Gen-Probe Receives Additional Blood Screening Funds
Diego, CA, October 1, 1998 - Gen-Probe Incorporated announced
today that it will receive $4.3 million from the National Heart,
Lung and Blood Institute (NHLBI) to develop a nucleic acid amplification
test for human immunodeficiency virus type 2 (HIV-2) and hepatitis
B virus (HBV) for use in blood screening. These funds, which will
be provided over a 30 month period, are in addition to Gen-Probe's
current $7.7 million 3-year contract for development of tests
for HIV-1 and hepatitis C virus.
Gen-Probe test is designed to improve the safety of the blood
supply by directly detecting the virus. Current tests detect antibodies
and antigens associated with the virus, which may not be detectable
for weeks or months after infection. The use of DNA probe testing
will reduce the "window" period for transmission of these viruses.
For example, the "window" for detection of HIV-1 is expected to
decrease from 16 days to 11 days.
NHLBI contract will enable Gen-Probe to complete the development
of these tests, conduct human clinical trials with approximately
30,000 individuals at a minimum of three sites, and then submit
the clinical data to the Food and Drug Administration for final
review and approval. Under the terms of the NHLBI contract, the
new blood screening products for HIV-2 and HBV, which are under
development, should be available and in use in blood banks across
the country by year-end 2001. Gen-Probe is also developing the
TIGRIS instrument, a fully automated system, which will be used
to perform these tests.
L. Nordhoff, president and chief executive officer of Gen-Probe
stated, "These additional funds reflect the progress we are making
in bringing ultra-sensitive nucleic acid test systems to the routine
clinical laboratory. We are very pleased to be a partner in helping
to ensure that the blood supply will be as safe as the latest
technology allows. As a result of our tests, fewer persons will
be at risk of acquiring HIV or hepatitis via blood transfusions."
a San Diego-based company, is the recognized world leader in the
development, manufacture and commercialization of diagnostic products
based on its patented genetic probe technologies. The company
has received 40 FDA clearances and approvals for genetic probe
tests to detect a wide range of microorganisms, including Chlamydia,
Mycobacterium tuberculosis and Neisseria gonorrhoeae. In 1997
Gen-Probe recorded revenues of $93.6 million and is one of the
few profitable biotechnology companies. It is also one of the
largest biotechnology firms in San Diego, employing over 500 people.
The company recently announced a strategic alliance with Chiron
Corporation to develop, manufacture and market nucleic acid probe
assay systems for blood screening and certain areas of diagnostics.
is a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd.
Chugai, a major pharmaceutical company in Japan, spends a higher
percentage of its sales on research and development than any other
large Japanese pharmaceutical company.