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FDA Approves BD HPV Genotyping Test

NEW YORK (GenomeWeb) – A molecular test from Becton Dickinson to detect 14 high-risk types of human papilloma virus has received pre-market approval from the US Food and Drug Administration, the company announced today.

The BD Onclarity HPV assay is designed for specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer screening. The test is clinically validated for use as a primary screening test, for triaging patients with abnormal Pap test results, and to be used in combination with a Pap test, BD said in a statement, adding it aligns with clinical screening guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology.

The Onclarity HPV test is performed on the BD Viper LT system, which the firm noted also runs FDA-cleared tests for chlamydia and gonorrhea infection.

"The addition of the BD Onclarity HPV assay to BD's women's health and cancer portfolio will enable BD to continue to enhance the standard of patient care, representing the next milestone in cervical cancer screening," said Dave Hickey BD Diagnostics Systems president.

The Onclarity HPV test was CE marked in 2014, received regulatory approval in Canada and Japan in 2017, and is currently commercially available in these markets.

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