New Amplified Molecular Tests Launched to Help Improve Diagnosis and Treatment of Herpes Patients

BD Diagnostics has CE Marked its first fully automated Molecular Assays for HSV-1 and HSV-2

Sep 11, 2011

Oxford, UK (11 April 2011) – Clinicians now have a new tool to help diagnose and ultimately treat patients with Herpes Simplex Viruses (HSV) – one of the most common sexually transmitted infections in the world.

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it has CE marked its the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in clinician-collected external anogenital specimens.

"Genital herpes simplex virus (HSV) is the most common cause of genital ulcers in the UK, where it represents the fourth most common sexually transmitted infection" said Dr Raj Patel FRCP, Consultant GUM/HIV physician, Senior Lecturer, University of Southampton. "Molecular tests provide us with faster and accurate results improving our ability to identify infected patients and deliver faster treatment, management and counseling of the patient."

The BD ProbeTec™ HSV-1 and HSV-2 Qx Amplified DNA Assays 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 to aid in the diagnosis of herpes infection.

"Our new HSV tests are part of a growing portfolio of molecular diagnostics that is designed to give clinicians the tools they need to better manage patients, whilst providing solutions that drive laboratory efficiency and maximise clinical responsiveness," said Dr Hilja Ibert, Vice President and General Manager, Europe, Diagnostic Systems, BD Diagnostics. "This is a valuable resource at a time when laboratories are constantly being challenged to deliver more for less."

Data suggest that laboratories using existing culture methods to diagnose HSV often experience significant false negative rates, missing up to 25 percent of true positive cases. In addition, many clinicians and laboratories do not distinguish between HSV-1 and HSV-2.

The new BD ProbeTec HSV-1 and HSV-2 Qx Assays offers 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 run tests for chlamydia and gonorrhea, along with HSV-1 and HSV-2, on a single automated run.

Troy Kirkpatrick

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