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BD Diagnostics Files for FDA Clearance for Herpes MDx Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – BD Diagnostics, a division of Becton Dickinson, announced on Monday that it has filed an application with the US Food and Drug Administration for 510(k) clearance of the first fully automated molecular tests for herpes simplex virus types 1 and 2.

The BD ProbeTec HSV-1 and HSV-2 Qx Amplified DNA assays will run on BD's Viper system with XTR technology, which uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV-1 from HSV-2 in clinician-collected external anogenital lesion specimens.

In a statement, BD said that laboratories running culture-based methods experience significant false negative rates and miss up to 25 percent of true positives. Many clinicians and laboratories also do not distinguish HSV-1 from HSV-2.

Culture tests take between two to 10 days for results, BD added. By comparison, its tests can read up to 96 positive or negative results in about two-and-a-half hours, and using the BD Viper system, results for Chlamydia and gonorrhea, in addition to HSV-1 and HSV-2 can be obtained in a single automated run, BD said.

In May, EraGen Biosciences' test received what it said is the first FDA clearance of a molecular test for HSV.

Wayne Brinster, BD Diagnostics' vice president and general manager for women's health and cancer, said that it is important for clinicians treating HSV to know precisely what they are dealing with. "Determining whether a patient has HSV and whether it is type 1 or 2 makes a big difference in how the infection is treated, especially with the increase in new anti-viral and suppressive therapies," he said.