[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
