US-based medical technology company Becton, Dickinson and Company (BD) has submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for its human papillomavirus (HPV) test, the BD Onclarity HPV Assay.
The PMA application for the Onclarity HPV Assay is supported by data derived from a two-year, prospective, multi-centre clinical trial conducted by BD which involved more than 33,000 women.
BD women's health and molecular diagnostics vice-president and general manager 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."
The BD Onclarity HPV assay targets E6/E7 DNA oncogenes and provides a pooled result and discrete genotyping information for Type 16 and 18 to guide informed treatment decisions for their patients.
BD seeks approval for the usage of its Onclarity HPV assay with BD SurePath specimens to detect 14 high-risk HPV types to determine the requirement of colposcopy for women aged 21 and older with abnormal (ASC-US) Pap test results.
The test together with cervical cytology can also be used for women aged 30 years and above to detect high-risk HPV and individually identify HPV genotypes 16, 18 and 45.
BD also seeks approval for the usage of the Onclarity HPV assay with the BD Viper LT System which is a bench-top molecular platform for chlamydia gonorrhea infection (CT/GC) testing.
The BD Viper LT System automates sample processing, DNA extraction, Real-Time Polymerase Chain Reaction (RT-PCR) amplification and detection with minimal lab technician intervention during processing.
A part of the BD Totalys System, the BD Viper LT System automates cervical cancer screening including BD SurePath Pap Test slide preparation, imaging and slide review coupled with automated aliquot capabilities for ancillary testing.