SAN DIEGO, Oct. 5 /PRNewswire-FirstCall/ -- Gen-Probe announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the APTIMA(R) HIV-1 RNA qualitative assay. The assay may be used as an aid in the diagnosis of acute and primary HIV-1 infection, and to confirm HIV-1 infection in an individual whose specimen is repeatedly reactive (positive) for HIV-1 antibodies. The assay is the first FDA-approved qualitative nucleic acid test (NAT) for these intended uses.
Gen-Probe expects to launch the assay in November in conjunction with the APTIMA HCV (hepatitis C virus) RNA qualitative assay. Detection of HCV RNA is evidence of active HCV infection. The APTIMA HCV assay may be used to detect HCV RNA in individuals with antibody evidence of HCV infection and evidence of liver disease, individuals suspected to be actively infected with HCV with antibody evidence, and individuals at risk for HCV infection with antibodies to HCV.
"We believe these two new qualitative viral products may fill a small yet important medical niche in the detection of two treatable but potentially life-threatening diseases, especially in light of new CDC guidelines that support increased testing for HIV, and new scientific publications regarding hepatitis C," said Steve Kondor, Gen-Probe's vice president of sales and marketing.
Qualitative assays detect the presence of viral genetic material and give a "yes-no" answer as to whether the target virus is present. In contrast, quantitative assays are used to estimate the amount of genetic material present in a sample. Gen-Probe's new viral products are not approved for quantitative use.
In September, the U.S. Centers for Disease Control and Prevention (CDC) published new recommendations for health care providers that are designed to make voluntary HIV screening a routine part of medical care for all patients aged 13 to 64. The CDC estimated that more than 250,000 Americans are HIV-positive but unaware of their condition, and said that early diagnosis is critical in order for people with HIV to receive life-extending therapy.
A recent article in the journal Hepatology (Vol. 44, No. 2, 2006) illustrated the value of monitoring patients with chronic hepatitis C infection with a highly sensitive nucleic acid test. In the study, independent academic researchers retrospectively tested stored blood samples with an assay identical to the APTIMA HCV RNA qualitative assay. The authors concluded that negative results with this assay were more predictive of sustained virological response (SVR) than were negative results achieved with a less sensitive polymerase chain reaction (PCR)-based assay. According to the authors, SVR is an important endpoint associated with durable eradication of HCV infection and long-term remission, if not cure, of disease.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 20 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 900 people. For more information, go to http://www.gen-probe.com/ .
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning new products, potential regulatory approvals, customer adoption, and results of future R&D studies are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that new products will not be cleared for marketing in the timeframes we expect, if at all, (ii) the possibility that the market for the sale of our new products, such as our qualitative APTIMA viral products, may not develop as expected, (iii) we may not be able to compete effectively, (iv) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (v) we are dependent on third parties for the distribution of some of our products. The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact:
Michael Watts
Sr. director, investor relations and
corporate communications
858-410-8673
© 2006 PR Newswire
