AEGiS-Reuters: Gen-Probe diagnostic test approved, shares soar

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Gen-Probe diagnostic test approved, shares soar

Reuters NewMedia - December 29, 2003


NEW YORK (Reuters) - Gen-Probe Inc. on Monday said the U.S. Food and Drug Administration approved its automated system for diagnostic testing for sexually transmitted diseases, sending its stock up 12 percent to an all-time high.

Gen-Probe said the FDA approved running its Aptima Combo assay, an already approved nucleic acid test for simultaneous testing for Chlamydia trachomatis and Neisseria gonorrhea, on the company's Tigris DTS System.

The Tigris System is fully automated and is expected to allow laboratories to cut labor costs, minimize errors, and increase productivity, Gen-Probe said.

The company said it plans to expand its group of clinical diagnostic and blood screening tests that can be performed on the Tigris system.

Earlier this month, Gen-Probe filed an amended Investigational New Drug application with the FDA to initiate clinical trials of the Procleix Ultrio assay, which will test for HIV-1, hepatitis C and hepatitis B in blood, plasma, organs and tissue, on the Tigris System, the company said.

Gen-Probe said it intends to begin clinical trials of the assay on the Tigris System in January.

Gen-Probe shares traded up $3.68 at $36.85 on the Nasdaq, after hitting a record high of $37.23 earlier.


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