[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62915-62916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21905]


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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: A SNP-based blood test for predicting breast 
cancer survival and determining treatment strategies.
    Keywords: SNP Single Nucleotide Polymorphism Array Probe Breast 
Cancer.

Description of Technology

    Metastasis is a primary cause of patient morbidity and mortality in 
solid tumors. Although recent advances in genomic technologies have 
provided major insights into tumor etiology, there is a significant 
lack of knowledge regarding the factors that contribute to metastasis.
    Through studying the metastatic susceptibility of tumors, 
researchers at NCI's Laboratory of Cancer Biology and Genetics have 
discovered a select panel of single nucleotide polymorphisms (SNPs) and 
a method for predicting

[[Page 62916]]

breast cancer patient's survival. In this array, SNPs are analyzed from 
a patient's genomic DNA (gDNA); the result can be used to predict 
whether a patient is likely to respond to current breast cancer 
treatment strategies. This invention can reassure newly diagnosed 
patients that they have a high probability of responding to treatment 
and can also identify those patients that require alternative, more 
aggressive therapeutic strategies. Importantly, this invention has 
several advantages over the currently-offered gene expression-based 
breast cancer prognostic tests. Since this array can be completed 
following routine blood draw, rather than through a tumor biopsy, the 
samples are more stable, the process is quicker, simpler, less-
invasive, and more cost-effective than current methods.

Potential Commercial Applications

     Identification of patients with higher susceptibility to 
tumor progression (i.e., metastasis).
     Prediction of breast cancer survival (less than 10 years, 
for example) using array and methods.
     Personalization of patient treatment.
    Value Proposition: Since the array processes DNA from blood rather 
than tissue from a standard biopsy or resection of a primary tumor, it 
is faster, simpler, more stable, more cost-efficient, and less-invasive 
because gDNA is more stable than tumor mRNA.
    Development Stage: Pre-clinical (in vivo validation).
    Inventor(s): Kent W. Hunter, Ph.D. (NCI), Howard H. Yang, Ph.D. 
(NCI), Maxwell P. Lee, Ph.D. (NCI).
    Intellectual Property: HHS Reference No. E-082-2015/0-US-01
    US Provisional Application 62/297,557 (HHS Reference No. E-082-
2015/0-US-01) filed February 19, 2016 entitled ``SNP-Based Assay to 
Predict Breast Cancer Survival''.
    Collaboration Opportunity: Researchers at the NCI seek licensing 
and/or co-development research collaborations for methods that provide 
significant improvements in examining additional SNPs for improved 
prognostics, and to evaluate whether the SNP signature is associated 
with overall cancer incidence or effective treatment strategies.
    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: September 5, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-21905 Filed 9-12-16; 8:45 am]
 BILLING CODE 4140-01-P