Roche announces FDA 510(k) clearance for cobas HSV 1 and 2 Test

RocheJun 4 2015

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® HSV 1 and 2 Test for the direct detection and differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients. With dual target detection and automation, the cobas® HSV 1 and 2 Test provides laboratories with the capability to report up to 94 results in significantly less time than traditional methods and provides a simplified workflow for sample handling in the laboratory. This can help labs reduce costs, improve turnaround time and enable staff to spend more time on other critical tasks.

"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, Division of Infectious Diseases and Professor of Medicine, Epidemiology and Microbiology, University of Alabama. "Many genital herpes infections present with non- 'classical' genital lesions. Culture is clearly inferior to nucleic acid amplification testing and use of polymerase chain reaction (PCR)-based tests will lead to improved etiologic diagnosis and better patient care."

"The addition of the cobas® HSV 1 and 2 Test expands the menu for the cobas® 4800 System, enabling labs to experience increased efficiency with innovative testing solutions," said Paul Brown, head of Roche Molecular Diagnostics. "This highly sensitive and specific new test for the detection of herpes simplex virus delivers reliable results to physicians for optimal patient treatment and clinical management decisions."

Treatment guidelines cite the importance of sensitivity for HSV detection, and that PCR has demonstrated superior clinical performance to culture techniques^1-2. Using one of the fastest, most advanced real-time PCR detection methods available today, the cobas® HSV 1 and 2 Test offers accurate and reliable results through the use of simple and reliable sample collection technology and automated processing. The test is performed on the cobas® 4800 System, currently the only FDA-cleared system which offers the flexibility to run sexually transmitted infection and healthcare-associated infection tests, in the same run, on a single platform.