The FDA has cleared a second at-home cervical cancer screening kit, adding another option to a growing market for self-collected HPV tests that health officials say could save lives by reaching patients who rarely or never get screened.
The Onclarity HPV Self-Collection Kit, made by Waters Corporation, detects all high-risk, cancer-causing HPV genotypes, according to the company. Waters announced the clearance on April 8 and said the kit will be available in the coming months, covered by private insurance, Medicaid, and Medicare.
Cervical cancer is widely considered the most preventable form of cancer when caught early. HPV causes nearly all cases, and routine screening remains the standard recommendation even for people who have been vaccinated. Despite that, significant gaps in screening rates persist, particularly among Black and Hispanic women, who face disproportionately high rates of cervical cancer diagnosis and death.
The new kit follows the FDA's approval of the Teal Wand in May 2025, the first at-home HPV test cleared for consumer use. That product is available through a prescription. The Onclarity kit represents the second such option to reach the market, part of a broader shift in how cervical cancer screening is being delivered.
Federal guidelines have also moved in this direction. In January, the Health Resources and Services Administration updated its cervical cancer screening guidelines to endorse at-home self-swab HPV tests. That followed a recommendation from the U.S. Preventive Services Task Force supporting self-collection methods for people starting at age 30.
Supporters say the appeal of at-home testing is straightforward. Traditional screening, typically a Pap smear performed in a clinical setting, requires a pelvic exam that some patients find uncomfortable or difficult to access. People in rural areas, those without reliable transportation, and those who have experienced trauma may avoid in-person screenings for years. Self-collection removes several of those obstacles at once.
Jeff Andrews, vice president of medical affairs at Waters Advanced Diagnostics, said in a company statement that broader screening access gives clinicians better information to identify risks earlier. "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," he said. "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."
The company has promised what it describes as "broader nationwide access" once distribution begins. No specific launch date has been announced beyond the general timeframe of the coming months.
