Gen-Probe have announced that the FDA has granted marketing clearance for the Company’s APTIMA® assay for Neisseria gonorrhoeae (GC), an amplified nucleic acid test that detects, on a standalone basis, the bacterium that causes one of the most common STDs in the United States.

Gen-Probe’s primary amplified STD test is the APTIMA Combo 2® assay, which simultaneously detects Chlamydia trachomatis (CT) and GC. Like the APTIMA Combo 2 assay, the APTIMA GC assay was cleared to detect GC from the widest variety of sample types: clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The APTIMA GC assay can be run on Gen-Probe’s semi-automated DTS instruments.

In December, Gen-Probe received clearance to market its standalone APTIMA CT assay. With clearance to market the APTIMA GC assay, Gen-Probe now offers its customers the ability to test for the two most common bacterial STDs, in combination or separately, depending upon the needs of the patient and the market served.

Because all three tests use the same APTIMA technology, laboratories can provide a greater number of testing options without the added costs of using multiple platforms. The APTIMA assays complement Gen-Probe’s PACE product line, which continues to be the most widely used non-amplified nucleic acid test for these organisms.