Focus Diagnostics, a subsidiary of Quest Diagnostics, has obtained 510(k) approval from the US Food and Drug Administration (FDA) to add the genital swab claim to its Simplexa HSV 1 & 2 Direct molecular test on the integrated cycler.
The new labeling clearance comes after FDA’s de novo 510(k) clearance and CLIA moderate complexity categorization of the Simplexa HSV 1 & 2 Direct molecular test in March 2014.
At that time, the test received approval for use with cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis that can be caused by infection with herpes simplex 1 or 2 virus.
Focus Diagnostics research and development vice president Michelle Tabb said: "With nearly one in six adults 49 and younger infected with genital herpes, reliable, speedy diagnosis is key to patient care.
"The added genital swab claim significantly broadens our test’s potential clinical utility as an aid in diagnosing infection with one or both herpes simplex viruses."
Developed for use on the 3M integrated cycler, Simplexa tests are said to apply polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes.
According to the firm, the Simplexa HSV 1 & 2 Direct molecular test showed better performance in clinical studies, which will be presented at 2015 Annual Meeting of the Association for Molecular Pathology (AMP) meeting in Austin that will take place from 5 to 7 November.
Focus obtained FDA 510(k) approval for seven immunodiagnostic tests to detect herpes simplex viruses. In 2000, the firm received its first FDA approval for immunoassay test to detect immunoglobulin G (IgG) of both herpes simplex virus 1 and 2.