Cervical Cancer Identifying HPV Assay Approved by the USFDA
New Jersey-based BD (Becton, Dickinson and Company) has now received the FDA nod for its BD Onclarity HPV assay that detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening or “Pap test” in the BD SurePath liquid based cytology vial.
In addition, the test can also identify HPV genotypes 16, 18, and 45—genotypes that have been associated with the majority of cervical cancers on a global scale.
Results of the primary screening test could help to triage patients whose results come up as abnormal. Together with a physician’s assessment, information gathered from the BD Onclarity HPV Assay could be instrumental in clinical decision-making.
The FDA grants pre-market approvals (PMAs) to class 3 medical devices that, through scientific evidence and research, assure that the product is safe and effective in what it is intended to do. Obtaining a PMA grants the product marketing clearance in the United States.
The BD Onclarity HPV assay is designed for specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer screening. 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, BD said in a statement, adding it aligns with clinical screening guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology.“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 Dave Hickey, president, BD Diagnostics Systems. “The addition of the BD Onclarity™ HPV assay to BD’s women’s health and cancer portfolio will enable BD to continue to enhance the standard of patient care, representing the next milestone in cervical cancer screening.”
Dr. Thomas C. Wright, Jr., professor emeritus of pathology and cell biology at Columbia University noted that “The approval of the BD Onclarity™ HPV assay provides clinicians and laboratories an FDA-approved option for HPV primary screening with the BD SurePath™ liquid based cytology vial. The BD Onclarity™ HPV assay also aligns with clinical screening guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology and the American Society for Clinical Pathology.”
