[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30964-30965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12181]


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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 invention listed below is owned by an agency of the U.S. 
Government and is available for licensing 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: Benjamin Hurley; tel. 240-669-5092; 
[email protected]. Licensing information may be obtained by 
communicating with the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases, 5601 
Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

FRugally Optimized DNA Octamer (FRODO): DNA Vector and Uses Thereof for 
Detecting HIV and SIV

Description of Technology

    Quantitative polymerase chain reactions (qPCRs) are commonly 
employed to enumerate genes of interest among particular biological 
samples. Insertion of PCR amplicons into plasmid DNA is a mainstay for 
creation of known quantities of target sequences to standardize 
quantitative PCRs. Typically, one amplicon is inserted into one plasmid 
construct, the plasmid is then amplified, purified, serially diluted, 
and then quantified to be used to enumerate target sequences in unknown 
samples. As qPCR is often used to detect multiple amplicons 
simultaneously, individual qPCR standards are often desired to be 
normalized one to another. Unlike prior methods using separate plasmid 
constructs for each target sequence, FRODO incorporates eight amplicons 
into one plasmid construct ensuring equivalent template copy numbers 
for all amplicons. Amplifying, purifying, diluting and quantifying one 
plasmid construct rather than eight individual constructs streamlines 
standard curve qPCR analyses, reducing reagents and simplifying 
normalization between amplicons.
    This technology is available for licensing for commercial 
development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as 
well as for further development and evaluation under a research 
collaboration.

Potential Commercial Applications

     Clinical Detection, Monitoring of Nucleic Acid Markers of 
HIV and Immunological Health: FRODO may be used to efficiently quantify 
target sequences in unknown samples.
     FRODO is a single plasmid containing 8 amplicons which can 
be used to quantify several different strains of SIV and HIV, cell 
number equivalents for humans and nonhuman primates, T cell receptor 
excision circles (humans and nonhuman primates), and bacterial 16S and 
ampicillin resistance DNA.
     FRODO may offer improved, more affordable, highly-
sensitive nucleic acid-based HIV quantification and/or diagnostic 
response times, enhancing patient treatment and interventions.
     FRODO can be used to quantify levels of bacterial DNA in 
clinical samples to determine potential sepsis.
     This technology is especially useful in translational HIV 
research in which human and nonhuman primate models are used to study 
HIV pathogenesis, informing public health responses.

Competitive Advantages

     A simplified workflow for qPCR testing. Amplifying, 
purifying, diluting and quantifying one plasmid construct rather than 
multiple, individual constructs streamlines standard curve qPCR 
analyses, reducing reagents and simplifying normalization between 
amplicons.
     At present, there are a number of antibody-based clinical 
tools that may be used for diagnosing/detecting HIV, but there are 
fewer products that affordably detect/monitor nucleic acids of HIV 
within cells, and immunological health, and efficacy of medicaments

[[Page 30965]]

aimed at reducing cells infected with HIV.
    Inventors: Jason Brenchley and Charlotte Langner, both of NIAID.
    Publications: Langer, Charlotte A. and Brenchley, Jason M.; 
Frugally Optimized DNA Octomer (FRODO) qPCR Measurement of HIV and SIV 
in Human and Nonhuman Primate Samples; Current Protocols, 2021.
    Intellectual Property: HHS Reference No. E-024-2021; US Provisional 
Application No. 63/128,392.
    Licensing Contact: To license this technology, please contact 
Benjamin Hurley at 240-669-5092 or [email protected], and 
reference E-024-2021.
    Collaborative Research Opportunity: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize this invention. For collaboration 
opportunities, please contact Benjamin Hurley; 240-669-5092, 
[email protected].

    Dated: June 2, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-12181 Filed 6-9-21; 8:45 am]
BILLING CODE 4140-01-P