FDA Clears Two STD Tests for the Roche cobas 4800 Diagnostics System

Roche Molecular Diagnostics received FDA clearance for two new tests on its cobas 4800 PCR detection system. The cobas 4800 is a fully automated sample preparation device, which amplifies and detects DNA targets using real-time PCR. The device can run up to 94 tests in 4 hours, enabling rapid analysis of several STD screening tests. 5 different optical channels make it possible to detect multiple targets from one reaction tube. All reagents are easy to load and no thawing or mixing is required. An advanced results algorithm eliminates the need for extra manual curve analysis on the digitally captured data.

The two newly approved tests are used to detect chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs. The test runs in a multiplex dual probe assay, which means the two targets can be detected in only one sample.

A Human Papilloma Virus (HPV) test already received FDA clearance for the cobas 4800 in April of last year. This test simultaneously provides pooled results on high-risk genotypes like HPV 16 and HPV 18. This makes it possible for laboratories to combine the CT/NG Test and HPV Test onto a single platform.

According to the press release, the registrational trial for the cobas CT/NG test confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen. The self collection of specimen may help promote the screening compliance for sexually transmitted infections.

Barbara Van der Pol, assistant professor of epidemiology at the Indiana University School of Public Health was cited in the press release:

This test will contribute to lowering the burden of disease by providing accurate results from easy to obtain samples – self collected vaginal swabs from women and first catch urine from males. Allowing patients to be active participants in maintaining their health will encourage screening and facilitate clinic flow.

Product page:  cobas 4800 System

Press release: Roche receives FDA clearance for test to screen and diagnose chlamydia and gonorrhea infection in symptomatic and asymptomatic patients