Gen-Probe Received USFDA Clearance to Run Standalone APTIMA® Tests for Chlamydia and Gonorrhea on the TIGRIS® System

Filed in archive Diagnostics on October 20, 2006

The USFDA has granted marketing clearance that allows Gen-Probe Incorporated (Nasdaq: GPRO) to run its standalone APTIMA® assays for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) on the high-throughput, fully automated TIGRIS® system.

Previously approved to run on Gen-Probe's semi-automated instrument system, the two amplified nucleic acid tests detect the microorganisms that cause the most common bacterial sexually transmitted diseases (STDs) in the United States.

According to Steve Kondor, Gen-Probe's vice president of sales and marketing:

"With this clearance, customers can now run on the fully automated, high-throughput TIGRIS system all three APTIMA assays that were previously cleared for use on our semi-automated instruments, depending upon the needs of the patient and the market served.

We believe this clearance gives us the broadest menu of STD products in the industry. In addition, the five approvals or clearances we have received in the last two months illustrate our ability to commercialize innovative, high-value molecular diagnostic tests that help prevent serious medical complications and avoid unnecessary healthcare costs."

USFDA-cleared to run on the TIGRIS instrument in December 2003, Gen-Probe's primary amplified STD test, the APTIMA Combo 2® assay, simultaneously detects CT and GC. The APTIMA CT assay and the APTIMA GC assay received USFDA marketing clearance to run on Gen-Probe's semi-automated instruments in December of 2004 and March of 2005, respectively.

These three assays have been cleared to detect the target bacteria in a wide variety of sample types, including clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens.

The TIGRIS system is the only fully automated, high-throughput testing
instrument for molecular diagnostics.

Find more details from Gen-probe's press release.