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BD Diagnostics submits automated molecular assays for FDA approval

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has filed for US Food and Drug Administration (FDA) 510(k) clearance for the first fully automated molecular tests to diagnose and differentiate Herpes Simplex Viruses (HSV) types 1 and 2.

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

The new BD ProbeTec HSV-1 and HSV-2 Qx assays will improve accuracy and time to results over culture methods, which often take 2-10 days for results.

BD‘s new automated HSV assays will provide laboratories with the capability to read up to 96 positive or negative results in about two and a half hours.

Using the BD Viper System with XTR Technology, laboratories also will be able to run tests for chlamydia and gonorrhea, along with HSV-1 and HSV-2, on a single automated run.

BD Diagnostics Women’s Health and Cancer vice president and general manager Wayne Brinster said that when caring for a patient who may be suffering from HSV, clinicians need a precise picture of 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," Brinster said.