FDA Clears At-Home HPV Test with Extended Genotyping for Cervical Screening

Cervical cancer is largely preventable through regular screening and early detection of human papillomavirus (HPV), which causes nearly all cases. Yet roughly 60% of cervical cancers occur in people who are unscreened or under-screened, underscoring persistent access barriers. A new at-home self-collection kit and HPV assay now enable extended genotyping from clinician-ordered samples collected outside the clinic following recent U.S. Food and Drug Administration (FDA) decisions.

Waters Corporation announced FDA clearance of the Onclarity HPV Self-Collection Kit and FDA approval of the BD (Becton, Dickinson and Company) Onclarity HPV Assay with extended genotyping for at-home use. The combined offering is positioned to expand access to routine cervical cancer screening for individuals who face logistical, privacy, or other barriers to clinic-based testing. Waters is also establishing partnerships to broaden nationwide availability for patients and prescribers.

Image: A prescription kit is mailed directly to a patient’s home for self-collection, with the specimen then returned by mail to a laboratory for processing. (photo courtesy of BD)

The workflow enables a prescription kit to be mailed directly to a patient’s home for self-collection, with the specimen then returned by mail to a laboratory for processing. In the laboratory, specimens are analyzed using the BD Onclarity HPV Assay, which detects all high-risk, carcinogenic HPV genotypes and is the only FDA-approved HPV test that identifies six individual genotypes and three pooled genotype groups. Samples are processed on the fully automated BD COR System, which uses advanced robotics to prepare, analyze, and report results while preserving specimen integrity.

Waters collaborated with the National Institutes of Health’s National Cancer Institute through the Cervical Cancer “Last Mile” Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV testing. The kit is expected to be available by prescription in the coming months and is covered by private insurance, Medicaid, and Medicare. Results are shared with the patient’s healthcare provider to inform follow-up and care decisions.

"Expanding access to screening is one of the most important steps we can take to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete," said Jeff Andrews, M.D., FRCSC, Vice President of Medical Affairs, Waters Advanced Diagnostics, Waters Corporation.

"U.S. FDA clearance of the Onclarity Self-Collection Kit for at-home use marks a meaningful step towards removing today's primary barriers to screening, and supporting more personalized care," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "We're proud to provide this kit to advance earlier detection, achieve greater health equity, and ultimately reduce the burden of cervical cancer for women and persons with a cervix."

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