FDA clears new BD ProbeTec Qx Amplified DNA Assays to detect HSV 1 and 2

Clinicians now have a new tool to help diagnose symptomatic patients with Herpes Simplex Viruses (HSV1 and HSV2) -- one of the most common sexually transmitted infections in the world.  

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in clinician-collected external anogenital specimens.  

The new BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) run on the BD Viper™ System with XTR™ Technology, which uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA.

"HSV is a highly infectious virus that many patients do not even realize they have," said Edward W. Hook III, Director of Infectious Disease, University of Alabama at Birmingham Department of Medicine.  "Advances in molecular testing are enhancing our ability to identify these patients rapidly and accurately in order to treat them more effectively and minimize their risk of spreading it to others."

"Identifying HSV patients and determining whether they have a type 1 or 2 infection is critical to treating them effectively and preventing further spread of the disease," said Wayne Brinster, Vice President and General Manager, Women's Health and Cancer, BD Diagnostics.  "Our new HSV tests are part of a growing portfolio of molecular diagnostics that is designed to give clinicians better tools to manage patients who may be suffering from a variety of the most pressing sexually transmitted infections."

The new BD ProbeTec HSV Qx Assays offer excellent sensitivity and specificity and a significant improvement in the time-to-results over culture methods, which often take 2-10 days for results.  BD's new automated HSV assays also 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 test other samples for chlamydia and gonorrhea on the same automated run used for the BD ProbeTec HSV1 and HSV2 Qx Assays.  

The assays are not FDA cleared for use with cerebrospinal fluid (CSF) or any lesions other than anogenital lesions.  The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.

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