BD’s Onclarity HPV Self-Collection Kit has been cleared by the U.S. Food and Drug Administration (FDA) along with the approval of the BD Onclarity HPV Assay with extended genotyping, according to an announcement from Waters Corporation.
The goal of this action is to ensure more individuals have the opportunity to be screened for cervical cancer. Waters reported they are working on organizing partnerships to make the Onclarity HPV Self-Collection Kit more accessible and anticipate the product becoming available by prescription in the near future.
The kit and assay work in tandem to detect “all of the high-risk, carcinogenic genotypes of HPV.” The BD Onclarity HPV Assay “is the only FDA-approved HPV assay to identify six individually and three groups of pooled results.”
