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Becton Dickinson obtains FDA approval for HPV assay

The FDA granted Becton Dickinson premarket approval for its Onclarity HPV assay, a molecular test designed to spot 14 high-risk types of human papilloma virus in specimens gathered through the BD SurePath liquid-based cytology vial to screen patients for cervical cancer. The test, which runs on the BD Viper LT system, is clinically validated for use in combination with a Pap test, as a primary screening test and as a triage for abnormal Pap test results.

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