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BD's HSV Molecular Tests Receive FDA Clearance

By a GenomeWeb Staff Reporter

NEW YORK (GenomeWeb News) – BD Diagnostics today announced the US Food and Drug Administration has given 510(k) clearance for its automated molecular tests for the detection and differentiation of herpes simplex virus types 1 and 2.

According to BD Diagnostics, a segment of Becton Dickinson, the BD ProbeTec Herpes Simplex Viruses Qx Amplified DNA Assays are the first automated molecular assays for the detection and differentiation of HSV types 1 and 2 in clinician-collected external anogenital specimens. The assays run on the BD Viper platform with XTR technology, which uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA.

The assays are not cleared by FDA for use with cerebrospinal fluid or lesions other than anogenital lesions, the company said, and are not for use for prenatal screening or for individuals under the age of 17 years.

The assays offer "excellent sensivity and specificity," BD said, and using the assays, laboratories will also be able to read up to 96 positive or negative results in about two-and-a-half hours, compared to between two and 10 days with culture methods.

Using the Viper with XTR technology, labs will also 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 company said.

In a statement, Wayne Brinster, vice president and general manager for Women's Health and Cancer at BD Diagnostics, said that identifying HSV patients and then being able to differentiate those with type 1 and type 2 is "critical" for proper treatment.

"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," he said.

The company filed for FDA clearance in January.

In May 2010, EraGen Biosciences said its test for the herpes simplex virus had been cleared by FDA, making it the first molecular assay to receive such clearance.

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