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Gen-Probe

Gen-Probe Receives FDA Approval -- Stock Has Risen 211%

01/02/04 Gen-Probe, up 210.7% since our buy signal last January, on Monday received FDA approval for its innovative system designed to improve workflow and increase productivity for clinical labs. After the news was released, the stock shot up 12.6%.

Gen-Probe Inc. (ticker: GPRO) manufactures testing products used for the diagnosis of diseases and screening of donated human blood. If you missed out on our recommendation to buy Gen-Probe and the subsequent 211% jump in its price, then subscribe today.

More information about the FDA approval follows:

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

SAN DIEGO, CA, December 29 -- Gen-Probe Incorporated (Nasdaq: GPRO) 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(TM) 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.

“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.

 
 
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