Roche announced last week that it received FDA 510(k) clearance for the cobas HSV 1 and 2 Test to differentiate between the two causes of genital herpes infections. It will be conducted on the cobas 4800 System for real-time polymerase chain reaction amplification and detection.
Roche ($RHHBY) says knowing the type of herpes simplex virus impacts clinical decision-making. For instance, HSV-2 is considerably more likely to recur than HSV-1. Both types of herpes often go unrecognized, including 70% to 90% of patients in the case of HSV-2.
"Accurate diagnosis of genital herpes infections, whether caused by HSV-1 or HSV-2, has important personal and public health implications," said Dr. Edward Hook III, professor of medicine, epidemiology and microbiology at the University of Alabama, in a statement. "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 HSV tests to the Roche system further diversifies a diagnostic menu that already includes tests for human papillomavirus, MRSA/SA infections and genetic biomarkers for cancer like mutations to the BRAF gene.
The cobas HSV 1 and 2 tests enable labs to report up to 94 results faster than traditional methods and improves workflow, Roche says.
The company launched the HSV test in the Europe Union in 2014.
Clearance comes on the heels of FDA approval for its KRAS mutation test for metastatic colorectal cancer and the clearance of its rapid test for Clostridium difficile on the cobas 4800.
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