Gen-Probe Stock Rises on FDA Approval

Gen-Probe Inc. on Monday said the Food and Drug Administration approved its automated system for diagnostic testing for sexually transmitted diseases, sending its stock up 12% to an all-time high.

Gen-Probe, based in San Diego, said the FDA approved running its Aptima Combo assay, an already approved nucleic acid test for simultaneous testing for Chlamydia trachomatis and Neisseria gonorrhoeae bacteria, 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 system has the ability to process about 500 samples in an eight-hour shift and as many as 1,000 samples in about 13 hours, Gen-Probe said.

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

This month Gen-Probe filed an amended application with the FDA to initiate clinical trials of the Procleix Ultrio assay, which would test for HIV-1, hepatitis C and hepatitis B in blood, plasma, organs and tissue, on the Tigris system.

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

Shares of Gen-Probe rose $4.17 to $37.34 on Nasdaq.