[Federal Register Volume 60, Number 62 (Friday, March 31, 1995)]
[Notices]
[Pages 16655-16656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7994]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Opportunity For Licensing: HIV-1 Nucleocapsid Protein (p7nc) 
Capture Assay

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), Department of Health 
and Human Services (DHHS), seeks licensee(s) to develop a novel 
immunological capture assay for the detection of human immunodeficiency 
virus (HIV). Scientists at the National Cancer Institute have 
identified a new screening assay based on the detection in biological 
samples of p7nc, an HIV nucleocapsid protein. The assay is free from 
interference by antigen-antibody complexes. Potential uses for this 
assay include determining the prognosis of disease in an HIV-infected 
person, monitoring the effectiveness of antiviral treatment, detecting 
HIV infection in infants born to HIV-infected mothers, and detecting 
and quantitating HIV in laboratory experiments, i.e., virus production, 
infectivity assays, neutralization assays and drug effectiveness 
assays. NIH intends to grant the selected firm(s) world-wide royalty-
bearing license(s) to practice the inventions embodied in U.S. Patent 
Application Serial No. 07/967,658 from Dr. Larry O. Arthur and Dr. 
Louis E. Henderson entitled ``HIV Nucleocapsid Protein Capture Assay 
and Method of Use.'' The patent rights in these inventions have been 
assigned to the United States of America.

SUPPLEMENTARY INFORMATION: The current antigen capture assays for the 
detection of HIV-1 utilize the capsid antigen p24CA or the matrix 
protein p17MA. Antibodies to p24 and p17 found in HIV-1-infected 
persons interfere with the assays and limit their utility. The AIDS 
Vaccine Development Program at the National Cancer Institute-Frederick 
Cancer Research and Development Center has found that antibodies to p7 
are not prevalent in HIV-1-infected individuals. This observation 
coupled with the fact that p7 is found in equal molar quantities to p24 
in the virus, makes p7 an ideal candidate for an HIV antigen capture 
assay. A p7 capture assay has been developed and p7 assays of sera of 
seropositive individuals to which HIV-1 is added demonstrate that HIV-1 
can be detected. Similar experiments using commercial p24 assays are 
negative. The assay may be used for samples containing bodily fluids, 
tissues, or cell culture fluid. Because the assay is capable of 
measuring the nucleocapsid protein concentration, which correlates 
[[Page 16656]] with the level of infectious HIV in an infected person, 
it provides a surrogate marker for AIDS progression. This simple, 
rapid, quantitative, inexpensive assay may be used (1) As a prognostic 
indicator of HIV-1 infection and progression to AIDS; (2) in monitoring 
the effectiveness of anti-viral treatments; (3) to determine HIV-1 
infection in infants born to HIV-infected mothers; and (4) to determine 
if vaccinated persons are infected with HIV-1. In addition, the assay 
may be used to detect and quantitate HIV-1 in clinical and research 
laboratories such as propagation in cell culture, isolation from PBMCs, 
neutralization assays, drug-sensitivity assays, etc. The assay may 
serve as the basis for an ELISA or immunoblot kit.
    The NIH seeks licensee(s), who in accordance with requirements and 
regulations governing the licensing of government-owned inventions (37 
CFR part 404), have the most meritorious plan for the development of 
the assay to meet the needs of the public and with the best terms for 
the NIH. The criteria that NIH will use to evaluate exclusive or non-
exclusive license applications will include those set forth by 37 CFR 
404.7(a)(1)(ii)-(iv).

EFFECTIVE DATE: In view of the high priority for developing new drugs 
for the treatment of HIV infection, all proposals must be received by 
no later than May 30, 1995.

ADDRESSES: Requests for a summary of the technology or other questions 
and comments concerning the biomedical aspects of this technology 
should be directed to: Cindy Fuchs, J.D., Office of Technology 
Development, National Cancer Institute, 1003 West Seventh Street, P.O. 
Box B, Frederick, MD 21702-1201; Telephone 301/846-1501; Fax 301/846-
6820.
    Requests for a copy of the patent application, license application 
form, or other questions and comments concerning the licensing of this 
technology should be directed to: Steven M. Ferguson, Acting Chief, 
Infectious Disease Branch, Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
MD 20852-3804; Telephone 301/496-7735 ext 266; Fax 301/402-0220. A 
signed confidentiality agreement will be required to receive a copy of 
the patent application.

    Dated: March 17, 1995.
 Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-7994 Filed 3-30-95; 8:45 am]
BILLING CODE 4140-01-P