PRNewswire - December 29, 2003

"FDA clearance of our revolutionary TIGRIS System with the APTIMA COMBO 2 assay represents another first for Gen-Probe and for the molecular diagnostics industry that will significantly improve the efficiency of testing for sexually transmitted diseases," said Henry L. Nordhoff, chairman, president and chief executive officer of Gen-Probe. "We have delivered on our goal to lead the development of higher throughput, fully automated systems that can improve workflow and reduce laboratory costs. Now we will focus on expanding the menu of clinical diagnostic and blood screening tests that can be performed on the TIGRIS System."

The TIGRIS System, which is intended initially for clinical diagnostics and later for blood screening laboratories, is the first diagnostic instrument to truly automate NAT testing from start to finish. For example, no manual sample preparation is required to initiate a run and generate test results. The TIGRIS System is expected to significantly reduce labor costs, minimize testing errors, improve operator ergonomics and increase laboratory productivity.

"We were very impressed with the performance of the TIGRIS System during our clinical evaluation," said Edward W. Hook III, M.D., professor of medicine and epidemiology at the University of Alabama at Birmingham (UAB) and director of UAB's center for social medicine and STDs. "The combination of the TIGRIS instrument and the APTIMA COMBO 2 assay provided outstanding sensitivity and specificity that was equivalent to the semi-automated system. At the same time, however, the TIGRIS System was much easier to use and dramatically increased productivity and testing throughput."

Clinical laboratories in the United States are facing serious shortages of skilled technical labor, with vacancy rates for laboratory positions at a 12-year high. The scarcity of trained technicians, combined with the challenges of keeping up with new testing technologies, have led both large and small laboratories to increasingly seek out automated solutions that increase productivity, reduce costs and ensure that accurate results are produced in time to improve patient care.

The TIGRIS System has the ability to process approximately 500 samples in an eight-hour shift and up to 1,000 samples in approximately 13 hours. Because one trained operator can run two or three TIGRIS machines simultaneously, the productivity of a single technician using the TIGRIS System could be as much as 10 times greater than a technician using current semi-automated systems.

In mid-2003, Gen-Probe conducted a clinical evaluation that demonstrated agreement between results on the TIGRIS System and Gen-Probe's existing semi-automated system using the APTIMA COMBO 2 assay. Gen-Probe announced on July 18, 2003 that it had filed its FDA Pre-market Notification, also called a 510(k) application, ahead of schedule, for U.S. marketing clearance for STD testing on the TIGRIS System.

The TIGRIS System is intended for eventual use in blood screening laboratories. In December, Gen-Probe filed an amended Investigational New Drug application with the FDA to initiate clinical trials of the Procleix(R) Ultrio(TM) Assay on the TIGRIS System. The Ultrio Assay will simultaneously detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissue. Gen-Probe intends to begin clinical trials of the assay on the TIGRIS System in January.

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 or clearances for more than 60 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 first FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Chiron Corporation as the Procleix(R) System. Gen-Probe has 20 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 .

TIGRIS, APTIMA, DTS and Ultrio are trademarks of Gen-Probe Incorporated 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 our goals for the TIGRIS System, growth opportunities, and plans and objectives of management 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 TIGRIS System, 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 generate market acceptance 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 and a discussion of our financial statements and footnotes, see documents we have filed with the SEC, including the Form 10-Q for the quarter ended September 30, 2003, 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: Michael Watts, Senior Director, Investor Relations and Corporate Communications, Gen-Probe Incorporated, +1-858-410-8673

SOURCE Gen-Probe Incorporated

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

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