BD Diagnostics anoounced that they received clearance form FDA for its First Fully Automated Molecular Assays for HSV1 and HSV2. After this clinicians now have a tool to help diagnose patients with Herpes Simplex Viruses (HSV1 and HSV2).
BD Diagnostics, on March 28, 2011 announced that they received U.S Food and Drug Administration (FDA) 510(k) for their first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in clinician-collected external anogenital specimens. HSV is the most common sexually transmitted infections in the world.
The new BD ProbeTec HSV1, HSV2 ) Qx Amplified DNA Assays (HSV Qx Assays) which functions on the BD Viper™ System with XTR™ Technology. This uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA.
BD ProbTec HSV Assays have excellent specificity, sensitivity and have major improvement in the time-to-result over culture methods. This often take 2 to 10 days for getting results. BD’s new ProbTech HSV also provide labs with the ability to read up to 96 negative or positive result in just 2 and half hour. Labs using BD Viper System with XTR Technology will be able to test samples of Chlamydia and Gonorrhea on the same system. This system is not cleared form FDA using it other than Anogenital Lesions and are not to be used for Prenatal Screening for individuals under age 17.
Wayne Brinster, Vice President and General Manager, Women’s Health and Cancer, BD Diagnostics said “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.
Wayne Brinster also says “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. 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.”