Waters Corporation (NYSE: WAT) announced that the U.S. Food and Drug Administration has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay for at-home use.

The kit allows patients to collect samples at home for human papillomavirus testing, which is used to screen for cervical cancer. According to the company, approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened.

The BD Onclarity HPV Assay detects high-risk, carcinogenic genotypes of HPV and identifies six individually and three groups of pooled results. Samples are processed on the BD COR System using automated robotics.

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 will be available by prescription and covered by private insurance, Medicaid, and Medicare. Waters stated it is establishing partnerships to enable broader nationwide access, with availability expected in the coming months. Patients can receive the kit by mail, collect the sample at home, and mail it to a laboratory for processing. Results are shared with the patient's healthcare provider.

BD Biosciences and BD Diagnostic Solutions businesses were acquired by Waters Corporation, though Becton, Dickinson and Company remains the legal manufacturer of the products until regulatory transfers are completed.