The FDA cleared the Onclarity HPV Self-Collection Kit, allowing patients to collect samples at home for processing via the FDA-cleared BD Onclarity HPV Assay and BD COR System.
On April 8, 2026, the FDA cleared the Waters Corporation’s Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay, with extended genotyping for use at home, to expand access to cervical cancer screening. The company announced in a news release that the regulatory decisions could remove barriers for individuals that prevent the receipt of routine screening.1
Despite the availability of clinical screenings, approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened. Public health experts have identified at-home self-collection as an instrumental strategy for improving early detection rates and reducing overall mortality.
In January of this year, the Health Resources and Services Administration (HRSA)
"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, MD, FRCSC, Vice President of Medical Affairs at Waters Advanced Diagnostics, in a statement. “As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades, I have seen firsthand the profound difference early detection makes for patients. When more patients are able to get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner. That allows us to spend less time trying to reach patients who have fallen behind on screening and more time focusing on prevention, follow-up care, and treatment for those who need it."1
Related to the updated HRSA guidance for self-collection, Barbara Levy, MD, FACOG, FACS, clinical professor of obstetrics and gynecology at George Washington University School of Medicine and chief medical officer at Visana Health,
“This is huge,” Levy said. “In my over 40 years of practice in ob-gyn, the patients that I’ve had who had cervical cancer were people who never got screened.”
The self-collection kit is utilized in conjunction with the BD Onclarity HPV Assay, which detects all high-risk, carcinogenic genotypes of the virus. The assay is currently the only FDA-approved tool to identify 6 genotypes individually and 3 groups of pooled results.1
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 worked with the National Institutes of Health’s National Cancer Institute via the Cervical Cancer 'Last Mile' Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV testing.
"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,” added Jianqing Bennett, Senior Vice President of Waters Advanced Diagnostics.
According to the news release, “Waters is currently establishing partnerships to enable broader nationwide access to the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months. Covered by private insurance, Medicaid, and Medicare, the kit can be mailed directly to a patient's home, allowing them to collect a sample at their convenience and mail it to a laboratory for processing.”
From there, results are shared with the patient’s health care provider to gauge follow-up and further care decisions.
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