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BD seeks FDA approval for Onclarity human papillomavirus assay

MDBR Staff Writer Published 07 September 2016

Becton, Dickinson and Company (BD) is seeking approval from the US Food and Drug Administration (FDA) for its Onclarity human papillomavirus (HPV) assay.

The company has submitted a pre-market approval (PMA) application to the FDA for the Onclarity HPV test.

BD has submitted PMA application based on the data of a two-year multi-center clinical trial, which assessed more than 33,000 women.

The PMA has been submitted for use of the BD Onclarity HPV assay with SurePath specimens to detect 14 high-risk HPV types to determine the need for referral to colposcopy for women 21 and older with abnormal (ASC-US) Pap test results.

BD Onclarity, along with cervical cytology, will also be used to adjunctively screen for high-risk HPV in women 30 years and older. It will also individually identify HPV genotypes 16, 18 and 45.

In addition, the assay will be used as a first-line primary cervical cancer screening test for women 25 years and older.

The firm’s submission seeks approval to use the assay on the BD Viper LT system, which is FDA-cleared molecular platform for chlamydia gonorrhea infection (CT/GC) testing.

BD women's health and molecular diagnostics general manager and vice president Doug White said: "The submission of BD's HPV PMA application marks the completion of a significant undertaking.

"Our goal is to provide clinical laboratories and clinicians with comprehensive cervical cancer screening solutions that include BD Onclarity HPV Assay, BD SurePath Pap Test and BD Totalys System processing automation."