A new at-home HPV test kit is ... Note
Fast Company

A new at-home HPV test kit is going national through Quest Diagnostics

Patients will soon have access to a new at-home cervical cancer test called Onclarity HPV Self-Collection Kit, a partnership between Waters and Quest Diagnostics. This kit, cleared by the FDA in April 2026, will be available in early 2027 and aims to eliminate barriers associated with traditional in-person pelvic exams. Patients can order the test through a clinician, collect a dry swab specimen at home, and return it for testing via mail or Quest service centers. This initiative seeks to reach underserved populations, as roughly 30% of eligible women are unscreened or underscreened due to factors like geography, cost, fear, or lack of awareness. HPV infection, often sexually transmitted, is linked to nearly all cervical cancer cases, with high-risk genotypes posing a significant threat. While cervical cancer is the fourth most common cancer in women, it is highly treatable, making regular screening crucial for prevention. The Onclarity test offers extended genotyping, providing more precise diagnostics than other self-collection kits and traditional Pap tests, which primarily look for cell abnormalities. The growing demand for at-home testing, spurred by experiences like the COVID-19 pandemic, has primed the market for such advancements. Quest Diagnostics' extensive network will facilitate the distribution of these kits, leveraging Waters' proven assay technology. This collaboration is designed to make vital cervical cancer screening more accessible and convenient for a broader population.
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