PRNewswire - November 20, 2002

Under the Company's collaboration agreement with Chiron, Procleix-branded assays are sold exclusively by Chiron to blood centers conducting NAT on donated blood or plasma intended for transfusion or further processing prior to administration to patients. The Procleix-branded assay is not sold to clinical diagnostic laboratories.

Any revenues expected from sales of the Procleix assay for the two additional intended uses were included in the Company's prior 2002 and 2003 year-end earnings guidance.

"We sought the voluntary source plasma claim in response to a request from the American Red Cross," said Henry L. Nordhoff, chairman, president and chief executive officer. "This extended approval on our blood screening license is indicative of Gen-Probe's ability to obtain regulatory approvals to meet the needs of our customers and to execute our strategy to help ensure the safety of the world's blood supply. Additionally, we see the significant benefits of a diagnostic NAT HIV test for customers outside of the blood banking market and are now pursuing a strategy to commercialize the dHIV test as a stand-alone diagnostic."

About the Procleix System

The Procleix system uses innovative NAT technology, developed by Gen-Probe, to detect HIV-1 and HCV in donated blood. The system is comprised of an assay to detect both viruses in a single test; discriminatory tests for each analyte; an enhanced semi-automated instrument system used to process the test (eSAS); custom, proprietary software; proficiency panels and external quality controls. All parts of the Procleix system have received FDA approval and/or clearance.

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 blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed worldwide to blood centers exclusively by Chiron Corporation. Gen-Probe and Bayer Corporation have formed a collaboration to develop, manufacture and market nucleic acid diagnostic tests for certain viral organisms, and under the agreement Bayer has the right to distribute these tests, including the recently approved VERSANT(R) HCV Qualitative Assay. 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 .

VERSANT is a registered trademark of Bayer Corporation Procleix is a trademark of Chiron Corporation

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 September 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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