[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4105-4106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00825]


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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.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by communicating with Vidita Choudhry, Ph.D., Office of Technology 
Transfer and Development, National Heart, Lung, and Blood Institute, 31 
Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 
301-594-4095; email: [email protected]. A signed Confidential 
Disclosure Agreement may be required to receive any unpublished 
information.

SUPPLEMENTARY INFORMATION: Technology description follows.

High-Throughput COVID-19 Diagnostic Test That Detects Both Viral and 
Host Nucleic Acid

    The virus that causes COVID-19 is designated severe acute 
respiratory syndrome coronavirus 2 (SARS-CoV-2). The rapid worldwide 
spread and impact of COVID-19 has created a need for accurate, 
reliable, and readily accessible testing on a massive scale. The 
subject invention describes development of a

[[Page 4106]]

massively paralleled multiplexed screening method using next generation 
sequencing (NGS). This method uses sample-specific barcoded indexes 
that detect both SARS-COV-2 virus and the host's transcriptional 
response to infection simultaneously. By matching existing laboratory 
protocols for PCR-based sample processing, this assay is easily 
incorporated into existing CLIA-certified facilities. This testing 
approach provides the capability for testing tens of thousands of 
patient samples in a large bolus, allowing accurate and fast-turnaround 
SARS-CoV-2 testing capacity at population scale, and permits massive 
scale monitoring of at-risk individuals with minimal processing delay.
    Potential Commercial Applications: Diagnostic test for detecting 
infectious organisms, including SARS-CoV-2.

Competitive Advantages

     Reduction in reagents needed to perform a test, reducing 
test cost and bottleneck of critical reagents used during nucleic acid 
amplification.
     Simultaneously detect the pathogen and a host's 
transcriptional response to infection by the pathogen.
     Gene expression information from the donor can be used to 
predict disease severity.
    Development Stage:
     Early stage.
     Data from tests of human samples available.
    Inventors: Ozwaldo Alonso Lozoya (NIEHS), and Brian Papas (NIEHS).
    Intellectual Property: HHS Reference No. E-241-2020-0; U.S 
Provisional Patent Application 63/116,031 filed November 19, 2020.
    Licensing Contact: Vidita Choudhry, Ph.D.; 301-594-4095; 
[email protected]. This notice is made in accordance with 35 
U.S.C. 209 and 37 CFR part 404.

    Dated: January 8, 2021.
Bruce D. Goldstein,
Director, National Heart, Lung, and Blood Institute, Office of 
Technology Transfer and Development.
[FR Doc. 2021-00825 Filed 1-14-21; 8:45 am]
BILLING CODE 4140-01-P