16 February 2018 - - Franklin Lakes, New Jersey-based global medical technology company Becton, Dickinson and Company (BD; NYSE: BDX) has received pre-market approval from the US Food and Drug Administration for the BD Onclarity HPV assay that detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening (Pap test) in the BD SurePath liquid based cytology vial, the company said.
The test The BD Onclarity HPV assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide, and are disproportionally responsible for up to 94% of glandular cervical cancer cases.
In evaluating the test, the FDA reviewed data collected during a multi-year, prospective, multi-center clinical trial conducted in the US that included more than 33,500 vaccinated and non-vaccinated women.
The BD Onclarity HPV assay may be used in accordance with clinical guidelines for cervical cancer screening and management to identify the presence of high-risk HPV types. 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.
The BD Onclarity HPV assay provides information that together with the physician's assessment and professional guidelines, may be used to inform clinical decision-making.
BD develops, manufactures, and sells medical supplies, devices, laboratory equipment, and diagnostic products worldwide.
The company provides solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, and support the management of diabetes.
Its nearly 50,000 associates across 50 countries work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety, and expand access to health.