The FDA has granted marketing clearance for sexually transmitted disease testing on the Gen-Probe TIGRIS® DTS System, a fully automated, high-throughput instrument for the molecular diagnostics marketplace. The TIGRIS® System has been approved to run Gen-Probes APTIMA COMBO 2® assay, an FDA-approved amplified nucleic acid test 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, says Henry L. Nordhoff, chairman, president, and CEO of Gen-Probe. We have delivered on our goal to lead the development of higher throughput, fully automated systems that can improve work flow 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, requires no manual sample preparation to initiate a run and generate test results. The system can process approximately 500 samples in an 8-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 semiautomated systems.
We were very impressed with the performance of the TIGRIS System during our clinical evaluation, says Edward W. Hook III, MD, professor of medicine and epidemiology at the University of Alabama at Birmingham (UAB) and director of UABs 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 semiautomated system. At the same time, however, the TIGRIS System was much easier to use and dramatically increased productivity and testing throughput.