DiaSorin Molecular LLC, Cypress, Calif, has received FDA clearance extending the sample type claims for its herpes simplex virus (HSV) direct assay, Simplexa HSV 1 & 2. The clearance expands the testable sample types to include genital swabs plus all cutaneous and mucocutaneous swab samples.

The company previously received FDA clearance for testing cerebrospinal fluid (CSF) samples with the assay. With the additional sample types, the DiaSorin Molecular Simplexa HSV 1 & 2 assay now claims the most comprehensive sample type coverage for HSV testing on the market. CE marking for the extended sample claims was attained late last year.

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Michelle Tabb, DiaSorin Molecular.

The Simplexa HSV 1 & 2 direct kit is a real-time polymerase chain reaction (PCR) assay used on the company’s Liaison MDX instrument for the in vitro qualitative detection and differentiation of HSV 1 and HSV 2 DNA in CSF and swab samples. The test does not require a DNA extraction step and processes up to eight samples per run in about 1 hour.

HSV 1 and HSV 2 cause a variety of diseases with multiple presentations, ranging from mucocutaneous and cutaneous lesions to fulminate encephalitis, a central nervous system infection with high mortality. Rapid detection of HSV infection through molecular testing is critical to decisionmaking for life-saving therapeutics. Clinical studies on patients of all age groups—from infants to adults—produced accurate results. Coverage for multiple sample types in a single assay of moderate complexity enables laboratories to easily manage various HSV testing needs with a single test.

“With this FDA clearance, we are able to meet our goal of offering the most comprehensive HSV molecular test available,” says Michelle Tabb, vice president for research and development at DiaSorin Molecular. “We are continually growing our test menu and expanding what the individual tests can do.”

To learn more, visit DiaSorin Molecular.