New HPV Test Kit for At-Home Use Secures FDA Clearance

The FDA has cleared a new at-home cervical cancer screening solution developed by Waters Corporation that enables individuals to collect their own samples outside of traditional clinical settings.

The Onclarity HPV Self-Collection Kit, used in combination with the FDA-approved BD Onclarity HPV Assay, allows patients to collect a vaginal sample at home and send it to a laboratory for analysis. The test detects high-risk strains of human papillomavirus (HPV), the primary cause of cervical cancer.

This marks a significant evolution in HPV screening. While earlier FDA decisions permitted self-collection in healthcare settings, this latest clearance expands the option to fully at-home use, removing longstanding barriers such as discomfort with pelvic exams, limited access to providers and logistical challenges.

Related: Teal Wand Approved as First At-Home HPV Test for Cervical Cancer Screening

The BD Onclarity HPV Assay provides extended genotyping capabilities, identifying multiple high-risk HPV strains, including six individual genotypes and additional grouped types. This level of detail can help clinicians better assess a patient’s cancer risk and guide follow-up care.

According to reports, approximately 60% of cervical cancer cases occur in individuals who are not regularly screened, underscoring the urgent need for more accessible screening options.

Waters said it is currently building partnerships to support nationwide access to the Onclarity HPV Self-Collection Kit, which is expected to become available by prescription in the coming months. 

The kit is anticipated to be covered by private insurance, Medicaid and Medicare, and can be shipped directly to a patient’s home, where they can collect a sample at their convenience before mailing it to a laboratory for analysis. Test results are then shared with the patient’s healthcare provider to inform follow-up care and clinical decision-making.

“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, Waters Advanced Diagnostics, Waters Corporation, in a press release.

What HPV Test Kits Are Approved for At-Home and Self-Collection Screening?

Besides Waters’ Onclarity HPV Self-Collection Kit, a growing number of HPV tests have been approved in recent years, including those with self-collection and at-home options.

In 2025, Teal Health’s Teal Wand test became the first approved device for at-home cervical cancer screening, allowing patients to collect samples themselves and mail them to a lab for analysis. 

In 2024, the FDA expanded approvals for assays like the BD Onclarity HPV Assay from Becton, Dickinson and Company and Roche’s cobas HPV Test to allow patients to self-collect vaginal samples in healthcare settings. 

And in October 2025, SimplyTest launched a saliva-based oral HPV test designed for use in dental and functional medicine settings, enabling early, non-invasive detection of high-risk HPV strains linked to oropharyngeal cancers.