FDA Clears C. diff, Genital Herpes Tests from Roche

Roche’s new tests to detect Clostridium difficile and genital herpes infection have been cleared by the FDA.

Both assays are performed on the company’s cobas 4800 System, which can now test for C. difficile, herpes simplex virus (HSV) 1 and 2, and methicillin-resistant Staphylococcus aureus all in the same run on a single platform.

“[Health care professionals] can run these assays together at least once in each shift, rather than once a day, which can greatly improve laboratory efficiency, ultimately leading to better infection control and patient care,” noted Steve Young, PhD, professor of pathology at the University of New Mexico, in a press release.

The cobas HSV 1 and 2 Test allows laboratories to report up to 94 results in less time than traditional culture methods, helping labs reduce costs and improve turnaround time.

“Accurate diagnosis of genital herpes infections, whether caused by HSV-1 or HSV-2, has important personal and public health implications,” said Edward Hook III, MD, director of the Division of Infectious Diseases at the University of Alabama, in a separate press release. “…Culture is clearly inferior to nucleic acid amplification testing, and use of polymerase chain reaction-based tests will lead to improved etiologic diagnosis and better patient care.”

Similarly, the cobas Cdiff Test provides timely results with a small number of pre-analytic steps, which facilitates earlier intervention for C. difficile-associated disease.

“Having the ability to provide a result quickly is important when supporting infection control for C. difficile," Dr. Young noted.