Waters and Quest Diagnostics to Launch Home-Based HPV Screening in US
Waters and Quest Diagnostics have partnered to offer at-home HPV testing kits by early 2027, aiming to improve screening accessibility for underserved populations.
Life sciences company Waters is collaborating with Quest Diagnostics to launch an at-home testing service for HPV, the primary driver of cervical cancer. The partnership will utilize the BD Onclarity HPV assay, which received FDA clearance for home use in April 2026. Under the new model, clinicians will order the test kits for patients, who can then collect samples at home and either mail them or drop them off at a Quest service center.
The initiative addresses barriers to conventional screening, including geographic isolation, lack of insurance, and patient discomfort with pelvic examinations. According to Dr. Jeff Andrews of Waters Advanced Diagnostics, approximately 30% of eligible women in the U.S. remain unscreened or underscreened. This self-collection model is designed to reach these individuals by removing the requirement for an in-person clinic visit.
The Onclarity test differentiates itself from standard Pap smears by detecting the presence of the virus itself rather than cell abnormalities. Furthermore, it provides extended genotyping, which allows for more granular diagnostic results. Dr. Damian Alagia of Quest Diagnostics noted that the model leverages consumer comfort with at-home testing, a behavior that accelerated significantly during the COVID-19 pandemic.
The companies plan to begin rolling out the service in early 2027, leveraging Quest’s existing network of 2,000 service centers to facilitate sample processing. The expansion marks a shift in preventive medicine, positioning at-home diagnostics as a primary tool for increasing public health compliance.