Just three genotypes of Human Papillomavirus (HPV) are responsible for up to 94 percent of cervical cancer cases. Now, clinicians can use Becton, Dickinson and Company’s (BD) Onclarity HPV assay to identify these HPV genotypes in patient samples collected for the Pap test, as part of their regular cervical cancer screening programs.
“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.”
The FDA has granted BD pre-market approval for the assay, which detects 14 different types of HPV. The Onclarity HPV assay can also identify genotypes 16, 18, and 45, which are responsible for the majority of cases of cervical cancer, and is designed to be used with the BD SurePath liquid based cytology vial.
While the assay can be used as a primary screening test, BD recommends that physicians use it in combination with the Pap test, particularly in the investigation of abnormal Pap results.
“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,” said Dr. Thomas C. Wright, Jr., professor emeritus of pathology and cell biology at Columbia University. “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.”
In addition to its FDA approval in the US, the BD Onclarity HPV assay was granted a CE mark in the EU in 2014. Last year, the in vitro diagnostic (IVD) was also approved by regulatory agencies in Canada and Japan.