Gen-Probe Receives FDA Approval for STD Testing on the TIGRIS® DTS™ System

Gen-Probe Incorporated announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for sexually transmitted disease testing on the company´s TIGRIS® DTS™ System, the first fully automated, high throughput instrument for the molecular diagnostics marketplace.

The TIGRIS® System has been approved to run Gen-Probe´s APTIMA COMBO 2® assay, an FDA-approved amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhoeae.

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 intends to begin clinical trials of the Procleix® Ultrio assay which will simultaneously detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissue, on the TIGRIS® System in January.