[Federal Register Volume 79, Number 23 (Tuesday, February 4, 2014)]
[Notices]
[Pages 6598-6609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

FOR FURTHER INFORMATION CONTACT: Licensing information and copies of 
the U.S. patent applications listed below may be obtained by writing to 
the indicated licensing contact at the Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to 
receive copies of the patent applications.

Nucleic Acid-based Compositions and Methods for the Species-Specific 
Detection of Pathogenic Candida Fungi

    Description of Technology: This invention pertains to the 
development of oligonucleotides for the rapid nucleic acid-based 
identification of the Candida fungi species C. haemulonii, C. kefyr, C. 
lambica, C. lusitaniae, C. norvegensis, C. norvegica, C. rugosa, C. 
utilis, C. viswanathii, C. zeylanoides, C. dubliniensis, and C. 
pelliculosa within biological samples. This identification is 
accomplished by targeting the internally transcribed spacer-2 (ITS2) 
region that is specific for each species. The assay is sensitive, 
specific and rapid. Implementation of the technology will facilitate 
earlier specific diagnoses, and lead to better antifungal therapy 
implementation for infected patients.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of Candida species from 
biological samples
     Addressing secondary infections of immunosuppressed 
individuals
    Competitive Advantages:
     Easily adapted for use in kits
     High-throughput capable
     Rapid and cost-effective
    Development Stage: In vitro data available
    Inventors: Christine J. Morrison, Errol Reiss, Cheryl M. Elie, 
Timothy J. Lott (all of CDC)
    Publication: Shin JH, et al. Rapid identification of up to three 
Candida species in a single reaction tube by a 5' exonuclease assay 
using fluorescent DNA probes. J Clin Microbiol. 1999 Jan;37(1):165-70. 
[PMID 9854084]
    Intellectual Property: HHS Reference No. E-340-2013/0--
     PCT Application No. PCT/US1998/015840 filed 30 Jul 1998, 
which published as WO 1999/006596 on 11 Feb 1999
     US Patent No. 6,242,178 issued 05 Jun 2001
     Various international issued patents
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-232-2013/0
     HHS Reference No. E-335-2013/0
     HHS Reference No. E-339-2013/0
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Nucleic Acid-based Compositions and Methods for the Detection of 
Pathogenic Candida or Aspergillus Fungi Species

    Description of Technology: This invention pertains to the 
development of oligonucleotides for the rapid nucleic acid-based 
identification of Candida or Aspergillus fungi species in biological 
samples. This identification is accomplished by the targeting the 
internally transcribed spacer-2 (ITS2) region that are unique to 
various Candida species. The assay is sensitive, specific and rapid. 
Implementation of the technology will facilitate earlier specific 
diagnoses, and lead to better antifungal therapy implementation for 
infected patients.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of Candida and Aspergillus 
species from biological samples
     Addressing secondary infections of immunosuppressed 
individuals
    Competitive Advantages:
     Easily adapted for use in kits
     High-throughput capable
     Rapid and cost-effective
    Development Stage: In vitro data available
    Inventors: Christine J. Morrison, Errol Reiss, Brian Holloway, Jong 
Hee Shin (all of CDC)
    Publication: Shin JH, et al. Rapid identification of up to three 
Candida species in a single reaction tube by a 5' exonuclease assay 
using fluorescent DNA probes. J Clin Microbiol. 1999 Jan;37(1):165-70. 
[PMID 9854084]
    Intellectual Property: HHS Reference No. E-339-2013/0--
     PCT Application No. PCT/US1997/016423 filed 15 Sep 1997, 
which published as WO 1998/011257 on 19 Mar 1998
     US Patent No. 6,235,890 issued 22 May 2001
     Various international issued patents
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-232-2013/0
     HHS Reference No. E-335-2013/0
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Nucleic Acid Assays for the Detection and Discrimination of Aspergillus 
Fungi Species within Biological Samples

    Description of Technology: This invention relates to assays for the 
detection and species-specific identification of Aspergillus fungi. 
Accurate clinical diagnosis of Aspergillus species has become 
increasingly important as certain species, such as A. terreus and A. 
fumigatus, are resistant to specific commonly employed antifungal 
compounds. Most contemporary fungal diagnostic methods are time-
consuming and inaccurate. This invention directly addresses those 
inadequacies by providing a method to rapidly and accurately 
differentiate all medically important species of Aspergillus based on 
differences in the DNA sequences of the internal transcribed spacer 1 
region of ribosomal DNA.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of Aspergillus species from 
biological samples
     Addressing secondary infections of immunosuppressed 
individuals or asthmatics
    Competitive Advantages:

[[Page 6599]]

     Easily adapted for use in kits
     Assay may be used in real-time PCR, in enzyme immunoassays 
and/or in microarrays
     High-throughput capable
    Development Stage: In vitro data available
    Inventors: Christine J. Morrison and Hans Peter Hinrikson (CDC)
    Publications:
    1. Hinrikson HP, et al. Assessment of ribosomal large-subunit D1-
D2, internal transcribed spacer 1, and internal transcribed spacer 2 
regions as targets for molecular identification of medically important 
Aspergillus species. J Clin Microbiol. 2005 May;43(5):2092-103. [PMID 
15872227]
    2. CDC Fact Sheet: Aspergillosis [http://www.cdc.gov/fungal/aspergillosis/]
    Intellectual Property: HHS Reference No. E-335-2013/0--
     PCT Application No. PCT/US2003/016076 filed 16 May 2003, 
which published as WO 2003/097815 on 27 Nov 2003
     US Patent No. 7,384,741 issued 10 Jun 2008
     US Patent No. 7,871,779 issued 18 Jan 2011
     Various international patents issued or pending
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-232-2013/0
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Nucleic Acid-based Differentiation and Identification of Medically 
Important Fungi

    Description of Technology: This invention entails nucleic acid-
based assays for detecting the presence of pathogenic fungi such as 
Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis, 
Pneumocystis brasiliensis, and/or Penicillium marneffei within a 
sample. Within a healthcare setting, this particular approach can 
greatly reduce pathogen identification time, better direct treatments 
and ultimately improve patient outcomes. Further, this technology 
provides improved diagnostic specificity compared to serologic tests 
for circulating antibodies using patient serum samples- an approach 
that may give particularly aberrant results for immunosuppressed 
individuals, and who are frequently afflicted with opportunistic fungi. 
This technology is readily adaptable as kits used for species-specific 
identification of fungal pathogen infections and environmental 
contamination.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of fungal pathogens
     Addressing secondary infections of immunosuppressed 
individuals or asthmatics
    Competitive Advantages:
     Rapid, sensitive, simple and specific
     Potential for automation and high-throughput screening
     Easily adaptable to kit form
    Development Stage: In vitro data available
    Inventors: Mark D. Lindsley, Zhenyu Qin, Christine J. Morrison, 
Jong S. Choi (all of CDC)
    Publication: Lindsley MD, et al. Rapid identification of dimorphic 
and yeast-like fungal pathogens using specific DNA probes. J Clin 
Microbiol. 2001 Oct;39(10):3505-11. [PMID 11574564]
    Intellectual Property: HHS Reference No. E-332-2013/0--
     PCT Application No. PCT/US2002/030605 filed 25 Sep 2002, 
which published as WO 2003/027329 on 03 Apr 2003
     US Patent No. 7,427,472 issued 23 Sep 2008
     Various international patents issued or pending
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-232-2013/0
     HHS Reference No. E-335-2013/0
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Nucleic Acid Detection of the Fungal Pathogen Histoplasma capsulatum 
from Clinical and Environmental Samples

    Description of Technology: This invention relates to detecting 
Histoplasma capsulatum by PCR using oligonucleotide probes specific for 
the fungus. Histoplasmosis is a mycotic infection of varying severity, 
usually localized in the lungs. Caused by H. capsulatum, infections are 
usually symptomatic but can develop into chronic disease, especially in 
immunocompromised individuals.
    Test samples may originate from the environment (soil, for 
example), where H. capsulatum spores are found or from clinical samples 
obtained from patients. Furthermore, the invention also provides for 
methods that detect the presence of H. capsulatum in a sample using a 
nested, or two-stage, PCR assay.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Occupational health and safety screening for workers who 
may encounter bird or bat waste
     Screening biological or soil samples for the presence of 
fungal pathogens
     Environment testing for immunocompromised patients
    Competitive Advantages:
     Rapid and precise
     Cost-effective
     Easily adapted for H. capsulatum detection kits
     Can positively identify small sample sizes of as few as 10 
spores
     High-throughput capable
    Development Stage: In vitro data available
    Inventors: Millie Schafer and Thomas Reid (CDC)
    Publications:
    1. Reid TM, Schafer MP. Direct detection of Histoplasma capsulatum 
in soil suspensions by two-stage PCR. Mol Cell Probes. 1999 
Aug;13(4):269-73. [PMID 10441199]
    2. CDC Fact Sheet: Histoplasmosis [http://www.cdc.gov/fungal/histoplasmosis/]
    Intellectual Property: HHS Reference No. E-313-2013/0--US Patent 
No. 6,469,156 issued 22 Oct 2002
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-232-2013/0
     HHS Reference No. E-335-2013/0
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Multiplexed Immunoassay for Rapid Serological Diagnosis of a Specific 
Viral Infection in Clinical Samples

    Description of Technology: CDC researchers have developed a 
multiplexed diagnostic assay for sensitive detection and distinction 
between viral group members based on the presence/absence of infection-
generated antibodies within a clinical serum sample. For example, this 
assay can be used for rapid discrimination of a clinical unknown as 
specifically a West Nile or St. Louis encephalitis viral infection. 
This is particularly beneficial as these two viruses are typically 
difficult to distinguish by standard serological assays.
    This new technique uses microsphere/microbead-based flow-analysis 
as a platform. Because of a basis in a pre-existing technology, the 
technique can be easily incorporated into current state and health 
department diagnostic testing protocols. The method is particularly 
unique because the assay-generated data can be standardized and then 
classified via discriminant analysis to determine the presence or 
absence of antibodies of interest within the clinical sample tested.

[[Page 6600]]

    Furthermore, along with allowances for single-result generation, 
data manipulation and classification algorithms allow for assay output 
comparisons to the original large data set references used in 
development. In this way, results from different laboratories can now 
be directly compared to one another, provided that the same controls 
are used.
    Potential Commercial Applications:
     Clinical diagnostics for specific identification and 
discrimination of viral infections
     Research tool for evaluation of vaccine candidates
     Assay standardization and quality control
     Public health and viral outbreak surveillance programs
    Competitive Advantages:
     Increased efficiency compared to single-antibody 
diagnostic approaches
     Easily implemented and integrated into present protocols 
and techniques, as this technology is based on current, widely used 
flow-analysis platforms
     Can be formatted as customizable kits for detection of 
viral group antibodies
     Rapid and precise
     Ideal for high-throughput analyses
    Development Stage: In vitro data available
    Inventors: Alison J. Basile and Bradley J. Biggerstaff (CDC)
    Publications:
    1. Basile AJ, et al. Removal of species constraints in antibody 
detection. Clin Vaccine Immunol. 2010 Jan;17(1):56-61. [PMID 19923570]
    2. Basile AJ, et al. Multiplex microsphere immunoassays for the 
detection of IgM and IgG to arboviral diseases. PLoS One. 2013 Sep 
25;8(9):e75670. [PMID 24086608]
    Intellectual Property: HHS Reference No. E-302-2013/0--
     US Patent No. 7,933,721 issued 26 Apr 2011
     US Patent No. 8,433,523 issued 30 Apr 2013
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4927; 
[email protected]

Detection and Differentiation of Pathogenic Fungi in Clinical Samples 
Using a Multi-Analyte Profiling System

    Description of Technology: This invention provides a rapid, 
sensitive and specific diagnostic tool for the detection of pathogenic 
fungi and subsequent species-specific discrimination. CDC scientists 
have developed nucleic acid probes to identify the six most medically 
important Candida species and endemic mycoses, and to differentiate 
them from other medically important fungi in a multi-analyte profiling 
system. Candida fungi are one of the leading causes of clinically-
acquired bloodstream infections and, although improved antifungal 
compounds have been recently introduced, they have unique, species-
specific treatment responses.
    This multi-analyte approach has the potential to simultaneously 
identify up to 100 different fungi in one assay. Additionally, the 
assay is quite cost effective in terms of resource input, time invested 
and technician labor. Used in conjunction with contemporary antifungal 
medications, this assay provides a very rapid and specific diagnosis 
allowing for the selective administration of appropriate compounds and 
ultimately improved patient outcomes.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of Candida species from 
biological samples
     High-throughput screening
     Liquid or solid phase microarray development to detect 
medically important fungi
    Competitive Advantages:
     Rapid, sensitive, simple and specific
     Multi-analyte nature provides cost-efficiency
     Easily adaptable to kit form
     Permits the multiplexing of up to 100 different 
hybridization reactions in a single sample
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Christine J. Morrison, Sanchita Das, Teresa Brown, Brian 
F. Holloway (all of CDC)
    Publication: Das, S. et al. DNA probes for the rapid identification 
of medically important Candida species using a multianalyte profiling 
system. FEMS Immunol Med Microbiol. 2006 Mar;46(2):244-50. [PMID 
16487306]
    Intellectual Property: HHS Reference No. E-293-2013/0--
     PCT Application No. PCT/US2006/037640 filed 26 Sep 2006, 
which published as WO 2007/038578 on 05 Apr 2007
     US Patent No. 8,119,788 issued 21 Feb 2012
     Several international filings issued or pending
    Related Technologies:
     HHS Reference No. E-232-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-335-2013/0
     HHS Reference No. E-339-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Novel Primate T-cell Lymphotropic Viruses (HTLV, STLV) for Development 
of Diagnostics, Therapeutics, Research Tools, and Vaccines

    Description of Technology: CDC researchers have isolated and 
characterized the novel primate T-lymphotropic viruses denoted human T-
lymphotropic viruses 3 and 4 (HTLV-3 and HTLV4), that are believed to 
have resulted from cross-species transmission at some point in the 
past. It has been previously established that HTLV-1 causes adult T 
cell leukemia and other inflammatory diseases; HTLV-2 is considered 
less pathogenic than HTLV-1 and has been associated with a neurologic 
disease similar to HTLV-1-associated myelopathy. At present, the human 
pathologies of HTLV-3 and HTLV-4 are yet uncharacterized, but have been 
identified as infecting rural Central African hunters who have much 
greater risk of contact with non-human primates, sometimes infected 
with simian T-lymphotropic viruses (STLVs). As HTLV infected 
individuals from rural, isolated populations have increasing contact 
with their urban brethren, there is increased potential for the rapid 
spread of new viral zoonotic-originating pathogens, much like the 
theorized ``bushmeat'' origins of HIV. There is a present and unmet 
need for increased surveillance, study, and preventative therapeutics 
directed towards mitigating the public health impact of these viruses. 
This CDC developed technology provides methods and tools to that end.
    Potential Commercial Applications:
     Development of HTLV diagnostics
     Simian/human T-cell lymphotropic virus research
     Zoonosis surveillance
     Vaccine design and development
    Competitive Advantages:
     Provides tremendous opportunity for phylogenetic, clinical 
and epidemiological investigations of HTLV and STLV
     Facilitates monitoring of viral diversity and study of 
zoonotic disease transmission
     Provides tools needed to address and mitigate a newly 
emergent blood-borne disease before widespread, regional/global viral 
dissemination occurs
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Donald S. Burke (Johns Hopkins Univ), Thomas M. Folks 
(CDC), Walid Heneine (CDC), Eitel Mpoudi

[[Page 6601]]

Ngole (CDC), William M. Switzer (CDC), Nathan D. Wolfe (Johns Hopkins 
Univ)
    Publications:
    1. Wolfe ND, et al. Emergence of unique primate T-lymphotropic 
viruses among central African bushmeat hunters. Proc Natl Acad Sci U S 
A. 2005 May 31;102(22):7994-9. [PMID 15911757]
    2. Switzer WM, et al. Ancient, independent evolution and distinct 
molecular features of the novel human T-lymphotropic virus type 4. 
Retrovirology. 2009 Feb 2;6:9. [PMID 19187529]
    Intellectual Property:
     HHS Reference No. E-281-2013/0--
--PCT Application No. PCT/US2006/005869 filed 21 Feb 2006, which 
published as WO 2006/091511 on 31 Aug 2006
--Various international patents granted and pending
 HHS Reference No. E-281-2013/1--

--US Patent No. 7,794,998 issued 14 Sep 2010
--US Patent No. 8,541,221 issued 24 Sep 2013
    Related Technologies: HHS Reference No. E-303-2013/2--
     PCT Application No. PCT/US2008/064270 20 May 2008, which 
published as WO 2008/144700 on 27 Nov 2008
     U.S. Patent Application No. 12/600,995 filed 19 Nov 2009
     U.S. Patent Application No. 14/013,947 filed 29 Aug 2013
     Various international patents granted and pending
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Method for Finding Usable Portion of Sigmoid Curve (the Taylor Method), 
Improved Assay Readouts, and Enhanced Quality Control/Assurance

    Description of Technology: CDC researchers have developed 
algorithmic methods for determining sigmoid curve optimums and 
calculating component concentrations. Sigmoid curves are commonly 
generated in bioassays and used to calculate results. Various 
techniques have been used to define the curve, analyze the 
observations, and calculate a concentration. This technology is an 
algorithmic approach to identifying the usable portion of a sigmoid 
curve. This approach is more objective than other methods, reducing the 
variability introduced by individuals and/or by repetition and allows 
substantially higher throughput in a situation where a lot of samples 
are being analyzed using the same assay.
    Potential Commercial Applications:
     Observation and data analysis
     Determining concentrations
     Improving calculations and estimations
     Enhancing consistency and reproducibility of outcomes for 
bio and chem assays
    Competitive Advantages:
     Less output-data subjectivity than alternate methods
     Rapid, accurate and simple to implement
     Quality control and assurance for a number of assays such 
as PCR, ELISA, toxin neutralization assays (TNA), flow cytometry, cell 
death assays, titrations, etc.
     Reduces data variability due to errant input
     Easily adapted to high-throughput analyses
     Demonstrated efficacy quantifying anthrax lethal toxin 
neutralization activity
    Development Stage: In vitro data available
    Inventor: Thomas H. Taylor (CDC)
    Publication: Li H, et al. Standardized, mathematical model-based 
and validated in vitro analysis of anthrax lethal toxin neutralization. 
J Immunol Methods. 2008 Apr 20;333(1-2):89-106. [PMID 18304568]
    Intellectual Property: HHS Reference No. E-270-2013/0--
     PCT Application No. PCT/US2004/008566 filed 19 Mar 2004, 
which published as WO 2004/084708 on 07 Oct 2004
     US Patent No. 7,469,186 issued 23 Dec 2008
     Australia Patent No. 2004224317 issued 25 Feb 2010
     Various international patent applications pending or 
issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Real-time PCR and High Resolution Melt Analysis for Genotyping of 
Chlamydophila psittaci

    Description of Technology: This nucleic acid assay employs Light 
Upon Extension (LUX) chemistry and High Resolution Melt (HRM) analysis 
to detect and distinguish the different genotypes of Chlamydophila 
psittaci. C. psittaci is an atypical pathogen which may result in 
severe pneumonia upon infection of birds, mammals and humans (depending 
on inter-relationships between host and pathogen genotypes). Presently, 
C. psittaci clinical identification is achieved by a cumbersome and 
time-intensive mix of ompA gene sequencing, microarray analysis, RFLP 
and/or serological testing. Accurate and timely molecular C. psittaci 
diagnosis techniques are not generally available in most clinical 
facilities, leading to improper treatment of patients.
    To that end, this robust CDC developed assay should be useful for 
epidemiological studies and may provide valuable information for best 
implementing public health measures in the event of outbreaks. This 
tool may also offer greater insight into the heterogeneity and 
dissemination of C. psittaci genotypes. Additionally, the assay can 
serve as a veterinary diagnostic and/or pre-screening tool for 
companion birds. Such applications would provide further benefit by 
resulting in reduced transmission of the disease to humans.
    Potential Commercial Applications:
     Validation studies, proficiency testing
     Public health and veterinary/zoonotic disease monitoring 
programs
     Diagnostic testing, especially within the poultry industry
     Disease screening of companion birds
    Competitive Advantages:
     Rapid and simple
     Simultaneous detection and discrimination of C. psittaci 
genotypes
     Improved efficiency in time and cost
     Easily adapted for use in kits
    Development Stage: In vitro data available
    Inventors: Stephanie L. Mitchell and Jonas M. Winchell (CDC)
    Publication: Mitchell SL, et al. Genotyping of Chlamydophila 
psittaci by real-time PCR and high-resolution melt analysis. J Clin 
Microbiol. 2009 Jan;47(1):175-81. [PMID 19005152]
    Intellectual Property: HHS Reference No. E-266-2013/0-US Patent 
Application No. 13/322,787 filed 28 Nov 2011
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Universal Diagnostic Assay for Detection and Identification of 
Poxviruses in Clinical Samples

    Description of Technology: CDC researchers have developed an assay 
for detection and diagnosis of poxviruses within clinical samples or 
from lab culture-systems. The assay specifically targets 
chordopoxviruses (except avipoxviruses) for PCR-based identification; 
an improvement upon the current standard of cell culturing 
methodologies. Individual chordopoxvirus species can cause disease in 
humans (e.g., vaccinia, cowpox, monkeypox/Molluscum contagiosum) and 
animals (e.g., sheeppox, myxoma, swinepox, mule

[[Page 6602]]

deer pox, tanapox/Orf virus, Bovine popular stomatitis virus). Some 
poxvirus species impart unique and obvious symptoms making them easy to 
diagnose, while many others are clinically ambiguous. For instance, 
parapoxvirus infections are often misdiagnosed as cutaneous anthrax, 
which unnecessarily contributes to overuse of antibacterial agents. 
There is therefore a demonstrated need to develop better diagnostic 
tools to detect and properly identify the agent of poxvirus infections. 
Regardless of the symptoms, this universal assay can quickly and 
reliably detect chordopoxvirus presence in clinical samples, allowing 
for proper identification, diagnosis, treatment, and improved patient 
outcomes.
    Potential Commercial Applications:
     Nucleic acid-based diagnostic for `unknown rash' illnesses 
and identifying novel poxviruses
     Disease surveillance programs, including public health and 
veterinary (livestock, domestic, wild/exotic)
    Competitive Advantages:
     Rapid and simple
     Allows for high-throughput, simultaneous sample screening
     Detects, identifies all low-G/C content non-avipox 
chordopoxviruses and most known high-G/C content chordopoxviruses
    Development Stage: In vitro data available
    Inventors: Yu Li, Inger K. Damon, Hui Zhao (all of CDC)
    Publication: Li Y, et al. GC content-based pan-pox universal PCR 
assays for poxvirus detection. J Clin Microbiol. 2010 Jan;48(1):268-76. 
[PMID 19906902]
    Intellectual Property: HHS Reference No. E-265-2013/0--
     PCT Application No. PCT/US2010/055061 filed 02 Nov 2010, 
which published as WO 2011/056771 on 12 May 2011
     US Patent Application No. 13/505,719 filed 02 May 2012
     Various international patent applications pending
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Novel Rift Valley Fever Virus Vaccines

    Description of Technology: This invention relates to recombinant 
Rift Valley fever (RVF) viruses containing deletions in one or more 
virulence genes. The recombinant RVF viruses, generated using a 
plasmid-based reverse genetics system, can be used as vaccines to 
prevent RVF infection in livestock and humans. The recombinant RVF 
viruses grow to high titers, provide protective immunity following a 
single injection, and allow for the differentiation between vaccinated 
animals and animals infected with wild-type RVF virus. Additionally, 
this technology relates to a method of using reverse genetics to 
generate recombinant RVF viruses.
    Potential Commercial Applications:
     Rift Valley fever (RVF) virus vaccine development or 
improvement
     Prevention of RVF virus infection in livestock and humans
     Biodefense, biosecurity
    Competitive Advantages:
     In vivo evidence shows single-dose protection
     Allows for discrimination between vaccinated and 
naturally-infected subjects
     Useful for controlled screening of therapeutic compounds
    Development Stage:
     In vitro data available
     In vivo data available (animal)
    Inventors: Brian H. Bird, Cesar G. Albarino, Stuart T. Nichol, 
Thomas G. Ksiazek (all of CDC)
    Publications:
    1. Bird BH, et al. Rift valley fever virus lacking the NSs and NSm 
genes is highly attenuated, confers protective immunity from virulent 
virus challenge, and allows for differential identification of infected 
and vaccinated animals. J Virol. 2008 Mar;82(6):2681-91. [PMID 
18199647]
    2. CDC Fact Sheet: Rift Valley Fever [http://www.cdc.gov/vhf/rvf/]
    Intellectual Property: HHS Reference No. E-254-2013/2--
     PCT Application No. PCT/US2008/087023 filed 16 Dec 2008, 
which published as WO 2009/082647 on 02 Jul 2009
     US Patent Application No. 12/809,561 filed 18 Jun 2008 
(select claims allowed as of 24 Oct 2013)
     Additional applications granted and pending
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Personal Air Sampler for Collecting Airborne Aerosol Particulates for 
Molecular Analysis

    Description of Technology: This invention consists of a sampling 
apparatus that utilizes one or more cyclone separators to collect 
airborne particles from the atmosphere. The apparatus not only 
separates out aerosols from the atmosphere, but also serves as a 
collection tube for aerosol particles. Through its unique design, this 
CDC-developed apparatus is able to use the centrifugal force of the air 
flow on aerosolized particles forcing them to separate. Since the 
sample is collected directly in a microcentrifuge tube, in situ 
analysis of the ambient particulates can be performed. Analysis may 
include, but is not limited to, PCR, immunoassay analysis, microscopic 
spore counting, and counting colony-forming units. The device should 
also have many additional uses for environmental surveillance and 
occupational health applications.
    Potential Commercial Applications:
     Analysis of ambient air particulates
     Environmental surveillance
     Occupational safety monitoring
     Biodefense
     Long-term exposure assessment
    Competitive Advantages:
     Rapid, on-site sampling and analysis
     Alternative to surface-sampling and culturing for 
aerosolized biological agents
     Superior extraction efficiency compared to filters, 
impingers, and impactors
     Real-world testing demonstrated device's ability to 
collect airborne mold and mycotoxins, pollen and pollen fragments, 
airborne dust particulates, as well as airborne influenza virus in a 
hospital environment.
    Development Stage:
     In situ data available (on-site)
     Prototype
    Inventors: Teh-Hsun R. Chen, Gregory Feature, Jyoti Keswani, 
Herbert D. Edgell (all of CDC)
    Publications:
    1. Lindsley WG, et al. A two-stage cyclone using microcentrifuge 
tubes for personal bioaerosol sampling. J Environ Monit. 2006 
Nov;8(11):1136-42. [PMID 17075620]
    2. Blachere FM, et al. Bioaerosol sampling for the detection of 
aerosolized influenza virus. Influenza Other Respir Viruses. 2007 
May;1(3):113-20. [PMID 19453416]
    3. Lindsley WG, et al. Measurements of airborne influenza virus in 
aerosol particles from human coughs. PLoS One. 2010 Nov 
30;5(11):e15100. [PMID 21152051]
    4. Cao G, et al. Development of an improved methodology to detect 
infectious airborne influenza virus using the NIOSH bioaerosol sampler. 
J Environ Monit. 2011 Dec;13(12):3321-8. [PMID 21975583]
    5. CDC-NIOSH Cyclone Bioaerosol Sampler Web page: http://www.cdc.gov/niosh/topics/aerosols/biosampler.html
    Intellectual Property: HHS Reference No. E-244-2013/0--
     US Patent No. 7,370,543 issued 13 May 2008
     US Patent No. 8,205,511 issued 26 June 2012

[[Page 6603]]

    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Warning System for Mobile Machinery Hazardous Zones

    Description of Technology: This invention relates to a warning 
system designed to protect individuals working near hazardous 
machinery. The system consists of a proximity-warning transmitter 
mounted to hazardous machinery and a receiver, worn by a worker, 
capable of detecting the transmitter signal. This worker-safety system 
can incorporate visual alerts and audible alerts. It also allows 
automatic shutdown of machinery upon receiver activation and may be 
particularly useful in the mining industry.
    Potential Commercial Applications:
     Auxiliary safety equipment for heavy machinery
     Occupational health and safety
     Mining worker safety
    Competitive Advantages:
     Easy transmitter installation
     Signal can be adjusted for an audio or visual ``warning 
zone alert'' and a proximal ``imminent danger zone alert''
    Development Stage:
     In situ data available (on-site)
     Prototype
    Inventors: William H. Schiffbauer and Carl W. Ganoe (CDC)
    Publication: Schiffbauer WH. A workplace safety device for 
operators of remote-controlled continuous mining machines. Am J Ind 
Med. 1999 Sep;Suppl 1:69-71. [PMID 10519790]
    Intellectual Property: HHS Reference No. E-239-2013/0--US Patent 
No. 5,939,986 issued 17 Aug 1999
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Species-specific Nucleic Acid Detection Assay for Fungi

    Description of Technology: This invention pertains to nucleic acid-
based assays for the detection of Aspergillus and other filamentous 
fungi. Assays cover the species-specific detection and diagnosis of 
infection by Aspergillus, Fusarium, Mucor, Penecillium, Rhizomucor, 
Absidia, Cunninghamella, Pseudallescheria or Sporthrix in a subject. 
This can reduce identification time from several days by conventional 
culture methods to a matter of hours. Furthermore, genus-specific 
probes are also provided for Aspergillus, Fusarium and Mucor, in 
addition to an ``all-fungus'' nucleic acid probe. This technology is 
readily adaptable as kits used for species-specific identification of 
opportunistic pathogen infections or possible work/home contamination.
    Potential Commercial Applications:
     Directing antifungal drug therapy for improved patient 
outcomes
     Detection, discrimination of fungal species from 
biological samples
     Addressing secondary infections of immunosuppressed 
individuals or asthmatics
    Competitive Advantages:
     Rapid, sensitive, simple and specific
     Cost-efficiency compared to culture or sero-diagnostic 
methods
     Easily adaptable to kit form
     High-throughput screening
    Development Stage: In vitro data available
    Inventors: Christine J. Morrison, Errol Reiss, Jong Soo Choi, 
Liliana Aidorevich (all of CDC)
    Intellectual Property: HHS Reference No. E-232-2013/0--
     US Patent No. 6,372,430 issued 16 Apr 2002
     US Patent No. 7,052,836 issued 30 May 2006
    Related Technologies:
     HHS Reference No. E-293-2013/0
     HHS Reference No. E-332-2013/0
     HHS Reference No. E-335-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Improved Protein Quantification Process and Vaccine Quality Control 
Production

    Description of Technology: This CDC invention is a method for 
identifying and quantifying a group of proteins in a complex mixture by 
a liquid chromatography-tandem mass spectrometry assay. The technology 
was developed for influenza although it can be used for a wide variety 
of protein quantification applications. As specifically developed, 
conserved peptides from the proteins of influenza (hemagglutinin, 
neuramidase, matrix 1 and 2, and nucleoprotein) have been synthesized 
and labeled to be used as internal standards for the quantification of 
those proteins in a complex (biological or manufactured) matrix. One or 
more of these peptides can be used to simultaneously detect and 
quantify the target proteins by establishing mass ratios and 
calibration curve comparison. This method for quantifying influenza 
proteins and peptides in samples has potential for improving vaccine 
production quality control and therefore, the effectiveness and overall 
cost-efficiency of influenza vaccines.
    Potential Commercial Applications:
     Vaccine production, especially influenza-related
     Quality assurance, quality control
     Influenza surveillance programs
    Competitive Advantages:
     Simultaneous, precise protein detection and quantification 
for complex mixtures
     Rapid; method cuts investigation/research time needed to 
formulate and optimize novel vaccines for emergent influenza strains
     Improved vaccine cost and production efficiency
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Tracie L. Williams, John R. Barr, Zhu Guo, Leah G. Luna, 
Ruben O. Donis, James L. Pirkle (all of CDC)
    Publications:
    1. Williams TL, et al. Quantification of influenza virus 
hemagglutinins in complex mixtures using isotope dilution tandem mass 
spectrometry. Vaccine. 2008 May 12;26(20):2510-20. [PMID 18440105]
    2. Pierce CL, et al. Quantification of immunoreactive viral 
influenza proteins by immunoaffinity capture and isotope-dilution 
liquid chromatography-tandem mass spectrometry. Anal Chem. 2011 Jun 
15;83(12):4729-37. [PMID 21591780]
    3. Williams TL, et al. Simultaneous quantification of hemagglutinin 
and neuraminidase of influenza virus using isotope dilution mass 
spectrometry. Vaccine. 2012 Mar 23;30(14):2475-82. [PMID 22197963]
    4. Woolfitt AR, et al. Amino acid analysis of peptides using 
isobaric-tagged isotope dilution LC-MS/MS. Anal Chem. 2009 May 
15;81(10):3979-85. [PMID 19364092]
    Intellectual Property: HHS Reference No. E-212-2013/0--
     PCT Application No. PCT/US2008/013396 filed 05 Dec 2008, 
which published as WO 2009/110873 on 11 Sep 2009
     US Patent No. 8,530,182 issued 10 Sep 2013
    Licensing Contact: Whitney Blair, J.D. M.P.H.; 301-435-4937; 
[email protected]

Novel Epitopes of Bacillus anthracis Lethal Factor for Development of 
Diagnostics and Therapeutics

    Description of Technology: CDC researchers have characterized 
epitopes of Bacillus anthracis Lethal Factor (LF), a critical component 
of the B. anthracis lethal toxin. These epitopes may allow for 
development of therapeutics for the treatment or prevention of B. 
anthracis infection. They may also allow screening for B. anthracis LF 
in a sample and development of a peptide anthrax vaccine.
    Potential Commercial Applications:

[[Page 6604]]

     Diagnostic tests assessing active Lethal Factor in a 
sample
     Anthrax neutralizing therapeutics and vaccines for B. 
anthracis
     Biodefense, biosecurity
    Competitive Advantages:
     Potentially faster, lower-input assay compared to current 
Edema Factor detection methods
     Easily adaptable for high-throughput screening of numerous 
specimens
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Jason Goldstein, Conrad Quinn, Dennis Bagarozzi, Anne 
Boyer (all of CDC)
    Publication: Boyer AE, et al. Detection and quantification of 
anthrax lethal factor in serum by mass spectrometry. Anal Chem. 2007 
Nov 15;79(22):8463-70. [PMID 17929949]
    Intellectual Property: HHS Reference No. E-210-2013/0--
     US Provisional Application No. 61/699,738 filed 11 Sep 
2012
     PCT Application No. PCT/US2013/059179 filed 11 Sep 2013
    Related Technologies:
     HHS Reference No. E-158-2013/2
     HHS Reference No. E-167-2013/0
     HHS Reference No. E-196-2013/0
     HHS Reference No. E-203-2013/0
     HHS Reference No. E-474-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Respiratory Syncytial Virus Immunogens for Vaccine and Therapeutics 
Development

    Description of Technology: CDC researchers have developed specific 
Respiratory Syncytial Virus (RSV) immunogens for use in the development 
of RSV-directed vaccines and therapeutics. RSV is the most common cause 
of serious respiratory disease in infants and young children and an 
important cause of disease in the elderly. To date, efforts to make a 
mutually safe and effective vaccine have been largely unsuccessful. 
This invention addresses both problems.
    CDC and collaborative researchers have demonstrated that a vaccine 
based on amino acid sequences corresponding to group-specific regions 
of the RSV G-protein can effectively induce antibodies, facilitate 
virus clearance, decrease the virus-induced inflammatory response to 
RSV challenge, and also decrease the enhanced disease following RSV 
challenge. This composition may be used alone as a vaccine to safely 
protect infants, children, and adults from RSV, as a booster with other 
RSV proteins or with inactivated virus as a vaccine to ensure that it 
can be given safely and effectively improve protection from RSV.
    Potential Commercial Applications:
     Prophylactic and therapeutic for the prevention and 
treatment of RSV infections
     Single or multi-component vaccine against RSV
     Improvements to currently developed/developing vaccines
     Developed antibodies may be employed for use in passive 
immunity or RSV research
    Competitive Advantages:
     Increased safety, effectiveness compared to current 
vaccines
     Findings suggest likely prevention or mitigation of RSV-
related pulmonary disease for previously established infections
    Development Stage:
     In vitro data available
     In vivo data available (animal)
    Inventors: Larry J. Anderson (CDC), Lia M. Haynes (CDC), Ralph A. 
Tripp (University of Georgia)
    Publications:
    1. Haynes LM, et al. Therapeutic monoclonal antibody treatment 
targeting respiratory syncytial virus (RSV) G protein mediates viral 
clearance and reduces the pathogenesis of RSV infection in BALB/c mice. 
J Infect Dis. 2009 Aug 1;200(3):439-47. [PMID 19545210]
    2. Miao C, et al. Treatment with respiratory syncytial virus G 
glycoprotein monoclonal antibody or F(ab')2 components mediates reduced 
pulmonary inflammation in mice. J Gen Virol. 2009 May;90(Pt 5):1119-23. 
[PMID 19264600]
    Intellectual Property:
     HHS Reference No. E-197-2013/0--

--US Patent Application No. 13/763,822 filed 11 Feb 2013
     HHS Reference No. E-197-2013/2--

--PCT Application No. PCT/US2010/044434 filed 04 Aug 2010, which 
published as WO 2011/017442 on 10 Feb 2011
--Several international patent applications pending
    Related Technologies:
     HHS Reference No. E-699-2013/0
     HHS Reference No. E-694-2013/0
     HHS Reference No. E-151-2013/0
     HHS Reference No. E-233-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Controlled Expression and Assembly of Human Group-C Rotavirus-like 
Particles for Creation of Rotavirus Diagnostic Assays and Improved 
Vaccine Formulations

    Description of Technology: CDC researchers have developed methods 
of producing unlimited quantities of Group-C (GpC) rotavirus antigens. 
GpC rotaviruses are a major, worldwide cause of acute gastroenteritis 
in children and adults that is distinct from Group-A rotavirus. 
However, GpC rotaviruses cannot be grown in culture, resulting in a 
lack of tools for detection and treatment of GpC rotavirus disease. 
Consequently, the true clinical burden of GpC rotavirus disease has not 
been clearly established.
    This technology allows for the expression of the three major capsid 
proteins (VP2, VP6 and VP7) of GpC rotavirus by recombinant baculovirus 
and assembly of virus-like particles (2-6-7 and/or 6-7) within insect 
cells. Further, this CDC generated technology allows for the large-
scale access to GpC rotavirus antigens, previously infeasible, and will 
permit use of these novel virus-like particles for the development of 
rotavirus diagnostic assays and improved vaccine formulations.
    Potential Commercial Applications:
     Development or improvement of rotavirus vaccines
     Rotavirus vaccine composition research
     Childhood illness vaccination programs and rotavirus 
monitoring endeavors
     Development of novel rotavirus diagnostic tools
    Competitive Advantages:
     Permits large-scale production of Group-C rotavirus 
antigens, previously impractical
     Produced virus-like particles/antigens can be used for 
rotavirus vaccines, other immunogenic uses and/or sero-diagnostic assay 
development
     Diagnostic tools for Group-C rotavirus are currently 
unavailable; this technology fulfills an unmet need for accurate 
assessment of the Group-C rotaviral global health burden
    Development Stage: In vitro data available
    Inventor: Baoming Jiang (CDC)
    Publication: Clark KB, et al. Expression and characterization of 
human group C rotavirus virus-like particles in insect cells. Virology. 
2009 May 10;387(2):267-72. [PMID 19285329]
    Intellectual Property: HHS Reference No. E-191-2013/2--
     PCT Application No. PCT/US09/045688 filed 29 May 2009, 
which

[[Page 6605]]

published as WO 2009/148964 on 10 Dec 2009
     US Patent Application No. 12/995,024 filed 26 Jan 2011
     Various international filings pending and/or deferred
    Related Technologies:
     HHS Reference No. E-122-2013/0
     HHS Reference No. E-150-2013/0
     HHS Reference No. E-153-2013/0
     HHS Reference No. E-521-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Diisocyanate Specific Monoclonal Antibodies for Occupational and 
Environmental Monitoring of Polyurethane Production Exposure-related 
Asthma and Allergy and Clinical Diagnosis

    Description of Technology: CDC researchers have developed 
monoclonal antibodies useful as diagnostics for diisocyanate (dNCO) 
exposure and for toxicity characterization of specific dNCOs. 
Currently, dNCOs are used in the production of all polyurethane 
products and are the most commonly reported cause of occupational-
induced asthma and also linked to allergic contact dermatitis. 
Presumptive diagnosis of dNCO asthma is presently dependent on criteria 
such as work history, report of work-related asthma-like symptoms and 
nonspecific airway reactivity to methacholine challenge.
    This invention is a cost-effective, objective alternative for 
clinical assessment of occupational/environmental dNCO exposure in 
patient samples. These antibodies may also provide for passive-
immunization and prevention of allergic contact dermatitis and/or 
asthma that can result from extended dermal exposure to dNCO 
contaminated surfaces and vapors. Further, the present technology 
allows for high-throughput testing of workplace dNCO air, fabric and 
working-surface contamination.
    Potential Commercial Applications:
     Occupational/environmental safety biomonitoring of 
polyurethane-worker/user exposure to diisocyanates(dNCOs)
     Clinical diagnostic use
     dNCO-induced allergy/asthma prevention by passive 
immunization
    Competitive Advantages:
     Ready for use in high-throughput immuno-histochemistry 
biomarker detection assays and kits
     Two sandwich ELISAs have been developed and validated 
using human samples
     Monitoring is currently performed by elaborate analytical 
chemical assays; this technology is more rapid and cost effective for 
dNCO exposure/contamination assessment
    Development Stage:
     Early-stage
     In vitro data available
    Inventors: Paul D. Siegel, Donald H. Beezhold, Tinashe Blessing 
Ruwona, Detlef Schmechel, Victor Johnson (all of CDC)
    Publications:
    1. Lemons AR, et al. Development of sandwich ELISAs for the 
detection of aromatic diisocyanate adducts. J Immunol Methods. 2013 Nov 
29;397(1-2):66-70. [PMID 24012971]
    2. Ruwona TB, et al. Monoclonal antibodies against toluene 
diisocyanate haptenated proteins from vapor-exposed mice. Hybridoma 
(Larchmt). 2010 Jun;29(3):221-9. [PMID 20568997]
    3. Ruwona TB, et al. Production, characterization and utility of a 
panel of monoclonal antibodies for the detection of toluene 
diisocyanate haptenated proteins. J Immunol Methods. 2011 Oct 28;373(1-
2):127-35. [PMID 21878336]
    Intellectual Property: HHS Reference No. E-189-2013/0--US Patent 
Application No. 12/577,241 filed 12 Oct 2009
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Real-time RT-PCR Assay for the Detection of Rift Valley Fever Virus in 
Humans and Livestock

    Description of Technology: A quantitative RT-PCR-based assay has 
been developed to rapidly detect all known strains of Rift Valley fever 
virus (RVFV). RVFV infections occur in both humans and livestock 
animals resulting in significant mortality and economic loss. Upon 
outbreak, RVFV has been known to cause devastating loss among livestock 
(primarily sheep and cattle) with outbreaks characterized by sweeping 
``abortion storms'' and elevation newborn animal mortality approaching 
100% in affected areas. The CDC-developed assay is capable of detecting 
and quantifying RVFV infection in both human and veterinary samples.
    Potential Commercial Applications:
     Diagnostic assay for the detection of Rift Valley fever 
virus in human and veterinary samples
     Research tool to quantitatively measure viral load in 
laboratory specimens
    Competitive Advantages:
     Assay detects positive infections for 33 known variants of 
Rift Valley fever virus
     Easily adaptable to kits for high-throughput screening of 
a large number of samples at once, useful for ensuring herd-health for 
example
    Development Stage: In vitro data available
    Inventors: Brian H. Bird and Stuart T. Nichol (CDC)
    Publications:
    1. Bird BH, et al. Complete genome analysis of 33 ecologically and 
biologically diverse Rift Valley fever virus strains reveals widespread 
virus movement and low genetic diversity due to recent common ancestry. 
J Virol. 2007 Mar;81(6):2805-16. [PMID 17192303]
    2. Bird BH, et al. Multiple virus lineages sharing recent common 
ancestry were associated with a Large Rift Valley fever outbreak among 
livestock in Kenya during 2006-2007. J Virol. 2008 Nov;82(22):11152-66. 
[PMID 18786992]
    Intellectual Property: HHS Reference No. E-187-2013/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Entangling/Entrapping Synthetic Setae for Control of Insects and Other 
Pests

    Description of Technology: In nature, some beetle larvae possess 
specialized barbed hastate setae that serve as an entanglement defense 
mechanism and incapacitate other insects. CDC researchers have 
developed synthetic setae for control and entrapment of insects and 
other pests. While smaller synthetic setae can trap mosquitoes and 
small insects, larger ``macro'' setae can be used for entrapment of 
bats, rodents, etc. Once used, the setae can be ``reset'' by a vigorous 
shaking of the fabric. This solution to pest control would be long-
lasting and non-toxic, with the additional benefit of avoiding the 
evolutionary selection of pesticide resistant organisms.
    Potential Commercial Applications:
     Insect and pest control agents
     Population sampling and monitoring
    Competitive Advantages:
     Fine entanglement setae can be used anywhere insects 
congregate, including mosquito bed netting, resting boxes, curtains, or 
wall linings
     Mosquitoes and other pests trapped in the setae will 
quickly desiccate
     Easy reuse of setae by shaking
     Long-lasting, non-toxic (no insecticide) alternative to 
insect control
    Development Stage: Prototype
    Inventor: Robert Wirtz (CDC)
    Intellectual Property: HHS Reference No. E-175-2013/0--US Patent 
Application No. 61/772,790 filed 05 Mar 2013
    Related Technologies:
     HHS Reference No. E-223-2013/0
     HHS Reference No. E-166-2013/0

[[Page 6606]]

     HHS Reference No. E-218-2013/1
     HHS Reference No. E-354-2013/1
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Sensitive Method for Detection and Quantification of Anthrax, 
Bordetella pertussis, Clostridium difficile, Clostridium botulinum and 
Other Pathogen-Derived Toxins in Human and Animal Plasma

    Description of Technology: CDC research scientists have developed a 
method to identify and quantify the activity of pathogenic bacterial 
adenylate cyclase toxins by liquid chromatography tandem mass 
spectrometry (LC-MS/MS). Bacterial protein toxins are among the most 
potent natural poisons known, causing paralysis, immune system 
collapse, hemorrhaging and death in some cases. A useful tool for 
quantitative detection of specific toxin activity in clinical samples 
will provide insights into the kinetics of intoxication, stage of 
infection and present stage of pathogenesis.
    This rapid, high-throughput analysis method will provide 
measurements that quantify the efficacy of toxin-based therapeutics and 
support patient management decisions during treatment. This technology 
is specific, ultrasensitive and can be implemented to detect toxins 
from a wide range of pathogenic bacteria. This method could be 
fabricated into a kit format to deliver to state or research 
laboratories for use during an anthrax emergency or for research 
purposes, i.e. animal studies evaluating anthrax therapeutics. This 
technology may be easily applied to detection/diagnosis of additional 
pathogenic bacterial species infections as well.
    Potential Commercial Applications:
     Detect toxins from a wide range of pathogenic bacteria
     Biodefense, biosecurity diagnostics
    Competitive Advantages:
     Presently no individual patient screening assay for 
anthrax-exposure is widely available; exposure is determined by public 
health investigation and environmental-sampling tests
     Current tests lack sensitivity and evidence of 
effectiveness
     Relatively rapid and exquisitely sensitive method for the 
detection and quantification of bacterial toxin activity from very 
small blood samples, accurately assessing exposure and infection
    Development Stage:
     In vitro data available
     In vivo data available (animal)
     In vivo data available (human)
    Inventors: Anne E. Boyer, Renata C. Lins, Zsuzsanna Kuklenyik, 
Maribel Gallegos-Candela, Conrad P. Quinn, John R. Barr (all of CDC)
    Publications:
    1. Duriez E, et al. Femtomolar detection of the anthrax edema 
factor in human and animal plasma. Anal Chem. 2009 Jul 15;81(14):5935-
41. [PMID 19522516]
    2. Boyer AE, et al. Quantitative mass spectrometry for bacterial 
protein toxins--a sensitive, specific, high-throughput tool for 
detection and diagnosis. Molecules. 2011 Mar 14;16(3):2391-413. [PMID 
21403598]
    Intellectual Property: HHS Reference No. E-167-2013/0--
     US Patent Application No. 13/878,378 filed 08 Apr 2013
     PCT Application No. PCT/US2011/059739 filed 08 Nov 2011, 
which published as WO 2012/074683 on 07 Jun 2012
     Various international filings pending
    Related Technologies:
     HHS Reference No. E-157-2013/0
     HHS Reference No. E-158-2013/2
     HHS Reference No. E-196-2013/0
     HHS Reference No. E-203-2013/0
     HHS Reference No. E-210-2013/0
     HHS Reference No. E-474-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

A Simple Colorimetric Assay for Anti-malarial Drugs Quality Assurance 
and Rapid, On-site Counterfeit Detection

    Description of Technology: This CDC assay aims to lessen the anti-
malarial drug counterfeiting epidemic by testing for the artemisinin-
type drugs (the active compound), through the use of a simple, 
inexpensive colorimetric test. Poor quality and counterfeit drugs pose 
an immediate threat to public health and undermine malaria control 
efforts, resulting in resistant-parasites and invalidates effective 
compounds, i.e. the artemisinins.
    In response to this threat, CDC researchers have developed a 
simple, inexpensive, field-adapted colorimetric test to determine 
artemisinin-derivative authenticity in anti-malarial tablets. This 
assay exploits a chemical reaction in which the active element in 
question readily reacts under mild conditions with diazonium salts 
producing a visually distinct green-colored product. The resultant 
product delineates a positive correlation between color intensity and 
the drug's concentration of active-compound; counterfeit drugs will 
have no or little change in color.
    Potential Commercial Applications:
     Quality assurance, fraud prevention for anti-malarials
     Public health and humanitarian concerns
     Artesunate, artemisinin sales and distributions
    Competitive Advantages:
     Potentially life-saving technology in developing nations 
and malaria affected regions
     Simple assay with an unaided-eye readout
     Inexpensive and field-adapted for use in low-resource 
environments
    Development Stage:
     In vitro data available
     In situ data available (on-site)
    Inventor: Michael D. Green (CDC)
    Publications:
    1. Green MD, et al. A colorimetric field method to assess the 
authenticity of drugs sold as the antimalarial artesunate. J Pharm 
Biomed Anal. 2000 Dec;24(1):65-70. [PMID 11108540]
    2. Green MD, et al. Authentication of artemether, artesunate and 
dihydroartemisinin antimalarial tablets using a simple colorimetric 
method. Trop Med Int Health. 2001 Dec;6(12):980-2. [PMID 11737833]
    Intellectual Property: HHS Reference No. E-161-2013/0--
     PCT No. PCT/US2008/082466 filed 05 Nov 2008, which 
published as WO 2009/061808 on 14 May 2009
     US Patent 8,435,794 issued 07 May 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Use of Detector Response Curves to Optimize Settings for Mass 
Spectrometry

    Description of Technology: This CDC developed optimization 
technology allows one to characterize the behavior of the coefficient 
of variation (CV) for a range of mass spectrometer machine settings. 
Surface-enhanced laser desorption/ionization (SELDI) and matrix-
assisted laser desorption/ionization (MALDI) are used for the early 
detection of numerous diseases, for example cervical cancer. A critical 
step in the analytical process is the optimization of experiment and 
machine settings to ensure the best possible reproducibility of 
results, as measured by the CV. The high cost of this procedure 
includes man hours spent optimizing the machine, opportunity cost, 
materials used, and spent biological samples used in the optimization 
process.
    This technology can be used to optimize the CV with the following 
advantages over conventional methods: (1) No need to use biological 
samples,

[[Page 6607]]

(2) fewer materials are consumed in the process, (3) improved CV and 
thus more reproducible results, (4) fewer man hours required to find 
ideal machine settings, and (5) potential full-automation of the 
process of optimizing CV. This idea is beneficial to all scientists and 
clinicians that use MALDI/SELDI for biomarker discovery and clinical 
diagnostics. Further, manufacturers of MALDI/SELDI mass spectrometer 
devices would find incorporation of this technology quite beneficial.
    Potential Commercial Applications:
     MALDI/SELDI mass spectrometer calibration improvement
     Biomarker discovery studies
     Quality control techniques
     Automated coefficient of variation (CV) optimization of 
mass spectrometer devices
    Competitive Advantages:
     Lower resource input requirement
     Increased cost efficiency
     Simplifies SELDI/MALDI setup, reducing technician man-
hours and need for extensive training
     Improves experimental optimization providing greater 
reproducibility
     Potential for automation of CV optimization
    Development Stage: In vitro data available
    Inventors: Vincent A. Emanuele and Brian M. Gurbaxani (CDC)
    Publications:
    1. Emanuele VA 2nd, Gurbaxani BM. Quadratic variance models for 
adaptively preprocessing SELDI-TOF mass spectrometry data. BMC 
Bioinformatics. 2010 Oct 13;11:512. [PMID 20942945]
    2. Emanuele VA 2nd, et al. Sensitive and specific peak detection 
for SELDI-TOF mass spectrometry using a wavelet/neural-network based 
approach. PLoS One. 2012;7(11):e48103. [PMID 23152765]
    Intellectual Property: HHS Reference No. E-157-2013/0--
     PCT Application No. PCT/US2011/055376 filed 07 Oct 2011, 
which published as WO 2012/048227 on 12 Apr 2012
     US Patent Application No. 13/575,317 filed 26 Jul 2012
    Related Technology: HHS Reference No. E-167-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Immunogenic Hepatitis E Virus Polypeptides for Vaccine and Diagnostics 
Development

    Description of Technology: This technology comprises specific 
hepatitis E virus (HEV) antigenic polypeptides. HEV causes epidemic and 
sporadic cases of hepatitis outbreaks with a mortality rate as high as 
20% for pregnant women. In order to address this problem, CDC 
scientists carried out thorough HEV antigen screenings and subsequently 
developed recombinant proteins that efficiently model major HEV 
neutralization epitope(s). These recombinant proteins may be considered 
as candidates for the development of an HEV subunit vaccine, as well as 
for the development of highly sensitive and specific diagnostic tests.
    Potential Commercial Applications:
     Development of a peptide subunit-based vaccine for 
hepatitis E virus (HEV)
     Development of HEV sero-diagnostic tools and reagents
     Blood transfusion screening
     Pregnancy screening safety precautions
     Hepatitis monitoring programs
     Basic research into hepatitis pathogenicity and immune 
response
    Competitive Advantages:
     Generated antibodies were cross-reactive with a number of 
geographically distinct HEV strains
     Useful for development of highly sensitive and specific 
diagnostic tests
     Could be useful for improving efficacy and HEV-strain 
immunity provided by current vaccine(s)
    Development Stage: In vitro data available
    Inventors: Howard Fields, Yury Khudyakov, Jihong Meng (all of CDC)
    Publication: Meng J, et al. Identification and characterization of 
the neutralization epitope(s) of the hepatitis E virus. Virology. 2001 
Sep 30;288(2):203-11. [PMID 11601892]
    Intellectual Property: HHS Reference No. E-152-2013/0--
     PCT Application No. PCT/US2001/010696 filed 03 Apr 2001, 
which published as WO 2001/077156 on 18 Oct 2001
     Various international patents issued
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

New Human Rotavirus Vaccine Strains

    Description of Technology: This invention relates to rotavirus 
vaccine compositions and methods of vaccination. The vaccine strains 
include Rotavirus A CDC-9 and CDC-66. These strains represent common 
rotavirus serotypes and may serve as improvements or alternatives to 
current live, oral rotavirus vaccine strains.
    Potential Commercial Applications:
     Novel rotavirus vaccines
     Childhood vaccination initiatives
     Rotavirus surveillance programs
    Competitive Advantages:
     Isolated strains are representative of those involved in 
community-acquired infection
     Suitable for the development of improved, broadly 
effective rotavirus vaccines
     Can be developed for injection and/or oral vaccine 
administration
     Derived vaccines may be administered alone or in 
combination with other vaccines
    Development Stage: In vitro data available
    Inventors: Baoming Jiang, Roger I. Glass, Yuhuan Wang (all of CDC)
    Publications:
    1. Esona MD, et al. Molecular characterization of human rotavirus 
vaccine strain CDC-9 during sequential passages in Vero cells. Hum 
Vaccin.;6(3). (Epub ahead of print) [PMID 20009519]
    2. Wang Y, et al. Inactivated rotavirus vaccine induces protective 
immunity in gnotobiotic piglets. Vaccine. 2010 Jul 26;28(33):5432-6. 
[PMID 20558244]
    Intellectual Property: HHS Reference No. E-150-2013/0--
     PCT Application No. PCT/US2010/034537 filed 12 May 2010, 
which published as WO 2010/132561 on 18 Nov 2010
     US Patent Application No. 13/320,095 filed 11 Nov 2011
     Various international filings pending or deferred
    Related Technologies:
     HHS Reference No. E-122-2013/0
     HHS Reference No. E-153-2013/0
     HHS Reference No. E-191-2013/2
     HHS Reference No. E-521-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Non-radioactive, Miniature Bipolar Aerosol Particle Charger for 
Personal, Portable Instrumentation

    Description of Technology: This CDC developed invention is a novel 
device for a miniature, nonradioactive bipolar charger to electrically 
charge aerosol particles for use in personal and portable aerosol 
instrumentation. Such devices are an integral component of aerosol 
instruments employing electrical mobility-based techniques. Current, 
commercial state-of-the-art mobility instruments employ aerosol 
chargers using radioactivity to achieve bipolar particle charging and, 
therefore, are not suitable for field-portable instruments. Due to 
strict regulatory restrictions on use of radioactive materials, these 
radioactive chargers also tend to be too bulky for use in compact 
aerosolization instruments.

[[Page 6608]]

    This invention circumvents these two critical drawbacks by 
eliminating radioactivity and miniaturizing overall unit size (1x0.75 x 
0.5 inch). Other unique aspects of the invention entail elimination of 
the need for additional air flows (other than the aerosol sample flow), 
minimal power consumption, a low per-unit cost, and simplicity of 
operation. In all, excellent transmission efficiency, steady-state 
charging characteristics and the miniature size make this bipolar 
particle charger well-suited for integration with portable or personal 
aerosol instrumentation.
    Potential Commercial Applications:
     Personal and portable aerosol instrumentation
     Component of field-use device for determining workplace/
environmental exposure to ultrafine aerosols and airborne nanoparticles
     Tool for environmental/occupational health, toxicology, 
workplace control evaluations and hazard identification involving 
aerosol exposure
    Competitive Advantages:
     Non-radioactive; no associated regulatory or 
transportation issues
     Low-cost and requires very little power to operate
     Additional air flows other than sample airflow are 
unnecessary
     Unit is small (1x0.75x0.5in; 2.54x1.91x1.27cm) and highly 
portable
     Eliminates a major barrier for reliable aerosol sampling 
using ``bipolar charger + differential mobility analyzer + condensation 
particle detector'' scheme in a compact device
    Development Stage: In situ data available (on-site)
    Inventors: Prarnod Kulkarni and Chaolong Qi (CDC)
    Intellectual Property: HHS Reference No. E-146-2013/0--US Patent 
No. 8,611,066 issued 17 Dec 2013
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Rapid Detection of Antiretroviral(s) Drug-Resistant HIV-1 Within 
Clinical Samples

    Description of Technology: One of the problems with the development 
of current therapies for HIV infection is that the virus rapidly 
develops resistance to drugs such as reverse transcriptase (RT) 
inhibitors. CDC researchers have developed an enzyme-based methodology 
for detecting phenotypic resistance to antiretroviral drugs whose mode 
of action decreases the efficiency of the HIV-1 RT enzyme.
    This invention will enhance clinical monitoring by providing data 
that tells physicians if and when the HIV-1 infecting a patient has 
become resistant to commonly used antiretroviral drugs, such as 
zidovudine/azidothymidine (AZT), nevirapine and lamivudine (3TC). This 
invention provides physicians and patient care facilities with a 
simple, rapid lab test that will tell them when a particular antiviral 
drug is not or no longer beneficial for a patient. Additionally this 
technology is superior to current culture-based methods for determining 
phenotypic resistance to HIV antiviral drugs, which are time-consuming 
and labor-intensive and therefore impractical for clinical monitoring.
    Potential Commercial Applications:
     Clinical monitoring of individual patient antiretroviral 
therapy
     HIV/AIDS public health programs
     Surveillance of retroviral drug resistance
    Competitive Advantages:
     Rapid diagnostic which greatly reduces time and labor for 
improved clinical monitoring of HIV treatment
     Ready for commercialization
     Easily adapted to kit format
     Assists continued usefulness of common antiretroviral 
therapeutics
    Development Stage: In vitro data available
    Inventors: Walid M. Heneine, Gerardo Garcia-Lerma, Shinji Yamamoto, 
William M. Switzer, Thomas M. Folks (all of CDC)
    Publication: Qari SH, et al. A rapid phenotypic assay for detecting 
multiple nucleoside analogue reverse transcriptase inhibitor-resistant 
HIV-1 in plasma. Antivir Ther. 2002 Jun;7(2):131-9. [PMID 12212925]
    Intellectual Property:
     HHS Reference No. E-129-2013/0--

--PCT Application No. PCT/US1999/013957 filed 16 Jun 1999, which 
published as WO 1999/66068 on 23 Dec 1999
--US Patent No. 6,787,126 issued 07 Sep 2004
--Various international patents issued
     HHS Reference No. E-129-2013/1--

--US Patent No. 7,691,572 issued 06 Apr 2010
    Related Technologies: HHS Reference No. E-232-1993--
     PCT Application No. PCT/US1996/001257 filed 26 Jan 1996, 
which published as WO 1996/023076 on 01 Aug 1996
     US Patent No. 5,849,494 issued 15 Dec 1998
     US Patent No. 6,136,534 issued 24 Oct 2000
     Various international patents issued or pending
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]

Antigen, Encoding Gene, Related Monoclonal Antibody and Hybridoma 
Clones for Streptococcus pneumoniae Serological Diagnostics

    Description of Technology: This CDC developed invention pertains to 
Streptococcus pneumoniae protein ``pneumococcal fimbrial protein A 
(PfpA),'' as well as the encoding pfpA gene. S. pneumoniae linked 
pneumococcal disease is prevalent among the very young, the elderly and 
also immunocompromised individuals. This invention covers the breadth 
of directly PfpA-related technology that might be employed for 
development of diagnostic tests for S. pneumoniae and/or vaccines 
directed against the pathogen. In addition to the intellectual property 
protected amino acid sequence and encoding plasmid, monoclonal 
antibodies and corresponding hybridomas are also available.
    Potential Commercial Applications:
     Screening diagnostic young, elderly and immunocompromised 
patients for possible S. pneumoniae infection
     Pneumococcal disease vaccine development or refinement
    Competitive Advantages:
     Easily adapted to a high-throughput assay for mass 
screening purposes
     Can be formatted as an on-site, lateral-flow diagnostic; 
both PfpA antigen and anti-PfpA mAb are available
    Development Stage: In vitro data available
    Inventors: Harold Russell, Jacquelyn Sampson, Steven P. O'Connor 
(all of CDC)
    Publications:
    1. Russell H, et al. Monoclonal antibody recognizing a species-
specific protein from Streptococcus pneumoniae. J Clin Microbiol. 1990 
Oct;28(10):2191-5. [PMID 2229341]
    2. Sampson JS, et al. Cloning and nucleotide sequence analysis of 
psaA, the Streptococcus pneumoniae gene encoding a 37-kilodalton 
protein homologous to previously reported Streptococcus sp. adhesins. 
Infect Immun. 1994 Jan;62(1):319-24. [PMID 7505262]
    Intellectual Property: HHS Reference No. E-157-1991/0--US Patent 
No. 6,312,944 issued 06 Nov 2001
    Related Technologies:
     HHS Reference No. E-030-2010/0
     HHS Reference No. E-250-2013/0
     HHS Reference No. E-325-2013/0
     HHS Reference No. E-660-2013/0
     HHS Reference No. E-661-2013/0
    Licensing Contact: Whitney Blair, J.D., M.P.H.; 301-435-4937; 
[email protected]


[[Page 6609]]


    Dated: January 27, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2014-02252 Filed 2-3-14; 8:45 am]
BILLING CODE 4140-01-P