[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58949-58950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20444]


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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 and/or co-development 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 and/or co-development.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing and co-
development research collaborations, and copies of the U.S. patent 
applications listed below may be obtained by contacting: Attn. 
Invention Development and Marketing Unit, Technology Transfer Center, 
National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 
Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of invention:
    Detection of Colorectal Cancer Using Two Heme-Related Molecules in 
Human Feces.
    Description of Technology:
    Mortality from colorectal cancer (CRC) can be reduced by detecting 
the cancer or its precursor, colorectal adenoma (CRA), so that it can 
be removed at an early stage. Current tests involve screening stool 
specimens for blood, especially for hemoglobin. The fecal 
immunochemical test (FIT) for hemoglobin is positive in stool for about 
60% of early-stage and 85% of advanced CRC cases, with a false-positive 
rate of less than 10%. Assays with better accuracy are still needed.
    The subject technology is a novel assay that detects the presence 
or absence of one or both of two heme-related peptides, X-18565 and X-
19549 in stool samples. The presence of one, and especially both, of 
these peptides within the stool sample indicates a high likelihood that 
CRC or CRA is present within the patient. X-18565 was detected in 67% 
of CRC cases and the specificity of X-18565 was 99%, as it was detected 
in only 1% of control patients who did not have CRC (e.g., false 
positives). X-19549 was detected in 48% of CRC cases and the 
specificity of X-19549 was 97%, as it was detected in only 3% of 
controls patients who did not have CRC (e.g., false positives). The 
absence of both X-18565 and X-19549 from the stool sample (or extract) 
indicates a greater than 95% likelihood that CRC or CRA is not present 
within the patient from which the stool sample is obtained. The assay 
can be performed on fresh or frozen samples.

[[Page 58950]]

Potential Commercial Applications:

     Diagnostic for colorectal cancer.

Value Proposition:

     Assay has high specificity.
     Fresh and frozen samples can be utilized by this assay.

Development Stage:

    Pre-clinical (in vivo validation).
    Inventor(s):
    James J. Goedert (NCI) and Rashmi Sinha (NCI).

Intellectual Property:

    HHS Reference No. E-198-2014/0-PCT-02.
    International PCT Application No. PCT/US2015/038299 (HHS Reference 
No. E-198-2014/0-PCT-02) filed June 29, 2015 entitled, ``Detection of 
Colorectal Cancer with Two Novel Heme-Related Molecules in Human 
Feces.''

Publications:

1. J.J. Goedert et al. Fecal Metabolomics: Assay Performance and 
Association with Colorectal Cancer. Carcinogenesis. 2014 
Sep;35(9):2089-96. [PMID: 25037050].

Collaboration Opportunity

    The NCI seeks licensing or co-development collaborations the would 
enable eventual commercialization of the diagnostic technology.

Contact Information

    Requests for copies of the patent application or inquiries about 
licensing, research collaborations, and co-development opportunities 
should be sent to John D. Hewes, Ph.D., email: [email protected].

    Dated: August 17, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-20444 Filed 8-25-16; 8:45 am]
 BILLING CODE 4140-01-P