FDA Approves New At-Home HPV Test for Cervical Cancer Screening, Expanding Access Nationwide

The FDA has approved another at-home cervical cancer screening option, further expanding access to early detection and prevention. The new Onclarity HPV Self-Collection Kit, developed by Waters Corporation, is designed to detect all high-risk, cancer-causing HPV genotypes, the company announced on April 8.

This approval follows the FDA’s clearance of the Teal Wand in May 2025, marking a significant shift toward self-collection methods in cervical cancer screening. Both tests are available with a prescription and aim to address barriers such as lack of access to care or discomfort with traditional screening methods like Pap smears.

How the Onclarity Kit Works

The Onclarity HPV Self-Collection Kit is a comprehensive screening tool that allows individuals to collect a sample at home for HPV testing. The kit will be available in the coming months and covered by private insurance, Medicaid, and Medicare, according to Waters Corporation.

“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, Vice President of Medical Affairs at Waters Advanced Diagnostics. “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.”

Why At-Home HPV Testing Matters

Cervical cancer is highly preventable with routine screening and early detection of HPV, which causes 90% of cases. However, 60% of cervical cancers occur in people who are under-screened or unscreened, often due to barriers like limited healthcare access or discomfort with traditional methods.

Self-collection methods are expected to reduce these barriers, particularly for populations facing disproportionately high risks, such as Black and Hispanic women. The U.S. Preventive Services Task Force (USPSTF) and the Health Resources and Services Administration (HRSA) have both endorsed self-swab at-home tests for HPV screening starting at age 30.

Key Facts About Cervical Cancer Screening

• HPV causes 90% of cervical cancer cases.
• 60% of cervical cancers occur in under-screened or unscreened individuals.
• The FDA approved the Teal Wand in May 2025, the first at-home cervical cancer test.
• The HRSA updated guidelines in January to endorse self-swab at-home HPV tests.
• The USPSTF recommends self-collection methods for screening starting at age 30.

What’s Next for At-Home Cervical Cancer Screening?

The Onclarity kit is expected to be available in the coming months, offering a new option for those seeking convenient and accessible cervical cancer screening. By reducing barriers to care, these at-home tests have the potential to save lives through earlier detection and intervention.