The test 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 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 percent of glandular cervical cancer cases.1,2 In evaluating the test, the
The BD Onclarity HPV assay may be used in accordance with clinical guidelines3,4 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 intends to seek approval in future submissions for reporting of HPV types beyond 16, 18 and 45 consistent with the extended genotyping capabilities of the assay's design and aligned with evolving cervical cancer screening guidelines.
'Our goal is to provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions that address the unique needs of individual healthcare providers and patients,' said
The BD Onclarity HPV assay is performed on the BD Viper LT system, a bench top molecular platform which automates sample processing and is also
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to better diagnose disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family.
Tel: 858 812 3724
Source : http://www.4-traders.com/BECTON-DICKINSON-AND-COM-11801/news/Becton-Dickinson-and-FDA-Approves-New-HPV-Test-that-Detects-and-Identifies-HPV-Genotypes-that-put-25999287/