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FDA approves addition of genital swab claim to HSV 1, 2 test
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Quest Diagnostics announced today that the FDA has given the company clearance to add a genital swab claim to its molecular test for herpes simplex virus types 1 and 2, according to a press release.
The Simplexa HSV 1 & 2 Direct molecular test is the first FDA-approved assay to use cerebrospinal fluid from patients suspected of herpes simplex virus (HSV) central nervous system infection, including encephalitis, according to the release. The test is designed to be used on the 3M Integrated Cycler and uses real-time PCR technology to detect DNA or RNA of viruses, bacteria and other substances. It uses a proprietary process that eliminates nucleic acid extraction, and results are delivered in approximately 1 hour.
The test previously received de novo 510(k) clearance from the FDA and was categorized as moderate complexity under the Clinical Laboratory Improvement Amendments in March 2014, allowing its use in certain physician offices, community hospitals, health clinics and delivery networks.
According to Quest Diagnostics, the test has performed well in clinical studies, and data from the studies will be presented at the Annual Meeting of the Association for Molecular Pathology in November.
“With nearly one in six adults [aged 49 years and younger] infected with genital herpes, reliable, speedy diagnosis is key to patient care,” Michelle Tabb, PhD, vice president, research and development for Focus Diagnostics, said in the release. “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.”
Focus Diagnostics has previously received FDA 510(k) clearance for six other immunodiagnostic tests for the detection of HSV, including group A streptococcal infections, influenza A and influenza B, and the 2007 approval of capillary sampling for an immunoglobulin G test for HSV type 2, according to the release.
Disclosure: Tabb is vice president of research and development at Focus Diagnostics.