PRNewswire - November 8, 2002

SAN DIEGO, Nov. 8 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO), an established leader in molecular diagnostics based on its patented nucleic acid testing (NAT) technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of its PreMarket Application (PMA) for its Qualitative HCV Assay.

Gen-Probe developed this amplified assay based on its proprietary Transcription-Mediated Amplification (TMA) technology. The Qualitative HCV Assay, which will be marketed by Bayer Corporation, Diagnostics Division, under the brand name VERSANT(R), is to be used by clinical laboratories to detect the presence of HCV in human plasma or serum in patients suspected to be actively infected with HCV or with evidence of the HCV infection.

Positive results from a clinical study of Gen-Probe's Qualitative HCV Assay were presented in a poster at the 53rd Annual Meeting of the American Association for the Study of Liver Disease (AASLD) conference in Boston MA.

The poster documented that the Qualitative HCV Assay is a highly reliable, sensitive, and specific means for detecting HCV RNA. The superior sensitivity permits more accurate detection of HCV infections, which will provide physicians with better information to make treatment and disease management decisions.

"Among the approved assays for the detection of HCV RNA in blood, the VERSANT(R) HCV RNA Qualitative Assay is the most sensitive," stated Eugene R. Schiff, MD, Center for Liver Diseases, University of Miami School of Medicine.

Dr. Schiff was lead investigator on the poster presented at AASLD and was one of the lead investigators for the assay clinical trial.

"Gen-Probe developed this amplified assay based on our proprietary TMA technology, which is the same technology that is used in our FDA-licensed HIV-1/HCV assay for screening donated blood," said Henry L. Nordhoff, chairman, president and chief executive officer of Gen-Probe. "The approval of the Qualitative HCV Assay represents the introduction of TMA to the clinical virology market. With its exquisite sensitivity, the assay provides significant benefit to patients infected with HCV."

Under the terms of the Gen-Probe/Bayer agreement, the VERSANT(R) HCV Qualitative Assay is currently distributed by Bayer in the following 11 countries: Japan, Canada, France, Switzerland, Spain, Italy, Germany, Belgium, Greece, the United Kingdom and the Netherlands.

About Hepatitis C Virus

Hepatitis C virus is a blood-borne pathogen posing one of the greatest health threats in developing countries. According to the National Women's Health Resource Center, up to 85% of individuals infected with HCV develop chronic liver disease, which could lead to both cirrhosis and liver cancer.

According to the World Health Organization, approximately 170 million people are infected worldwide with HCV. Studies indicate that HCV is transmitted through contaminated blood and blood products, other close personal contact, and intravenous drug use.

Recent advances in the treatment of patients with hepatitis C have led to the need for improved diagnostic tools and testing algorithms. Additionally, early detection allows for early intervention, which may improve the effectiveness of antiviral therapies for HCV. Utilizing the latest approved therapies, roughly 40-80% of patients on therapy can expect clearance of the virus from their systems. The therapeutic response rate is influenced by the HCV genotype. Successful treatment response is determined by utilizing a sensitive test to detect HCV RNA at the conclusion of therapy and upon follow-up testing -six months post-treatment. A significant percentage of patients who have no detectable viral RNA after the usual course of treatment subsequently relapse and show detectable levels six months later. Gen-Probe's Qualitative HCV Assay has been shown to be of value in identifying a greater number of those patients who continue to have HCV in their blood.

About Gen-Probe Incorporated

Gen-Probe Incorporated, founded in 1983, is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid testing (NAT) products used for the clinical diagnosis of human diseases and for screening donated human blood. Using its patented NAT technology, Gen-Probe has received FDA approvals for more than 50 products that detect a wide variety of infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Additionally, the Company developed and manufactures the only FDA approved bloodscreening assay for the simultaneous detection of HIV-1/HCV, which is marketed by Chiron. Gen-Probe has over 19 years of nucleic acid detection research and product development experience, and its products are used daily in clinical laboratories and blood collection centers throughout the world. Gen-Probe is headquartered in San Diego, California and has approximately 700 employees. Additional information about the Company can be found on the Internet at http://www.gen-probe.com .

Any statements in this press release about our 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 financial condition, possible or assumed future results of operations, growth opportunities, industry ranking, plans and objectives of management, markets for our common stock and future management and organizational structure 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 any results, levels of activity, performance or achievements 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 possibility that the market for the sale of our new products, such as our APTIMA Combo 2 assay, may not develop as expected, (ii) the enhancement of existing products and the development of new products may not proceed as planned, (iii) we may not be able to attract and retain key employees, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations, (vi) we may not be able to complete development of our TIGRIS instrument, (vii) we are dependent on Chiron Corporation and other third parties for the distribution of some of our products, (viii) we are dependent on a small number of customers, contract manufacturers and single source suppliers of raw materials, (ix) changes in third-party reimbursement policies regarding our products could adversely affect sales of our products, (x) changes in government regulation affecting our diagnostic products could harm our sales and increase our development costs, and (xi) our involvement in patent and other intellectual property litigation could be expensive and could divert management's attention.

The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For information about risks and uncertainties we face, a discussion of our financial statements and footnotes, see documents the company has filed with the SEC, including the Form 10 filed September 5, 2002, and the Form 10-Q for the quarter ended June 30, 2002 and all subsequent periodic fillings made with the SEC. 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 press release or to reflect the occurrence of unanticipated events.

For further information, please contact: Lora Pike, Director, Investor Relations of Gen-Probe Incorporated, +1-858-410-8673, Lorap@gen-probe.com; or Amy Sullivan, Senior Vice President and General Manager of Noonan Russo Presence Euro RSCG, +1-415-677-4455, ext. 219, a.sullivan@nrp-euro.com, for Gen-Probe Incorporated.

SOURCE Gen-Probe Incorporated

Web Site: http://www.gen-probe.com

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