Press release summary
Waters Corporation and Quest Diagnostics announced Oct. 20 a collaboration to expand U.S. access to the FDA-cleared Onclarity Self-Collection Kit for human papillomavirus screening beginning in 2027.
Quest plans to make the kit available through clinician, health-plan and consumer testing channels, supported by its national network of more than 2,000 patient service centers. Patients will collect vaginal samples at home and return them by mail or at a Quest location. Quest laboratories will process the specimens using the BD Onclarity HPV Assay on the automated BD COR system.
The assay individually identifies six high-risk HPV genotypes and reports three additional pooled genotype groups. The release said it supports current risk-based management guidelines and is intended as an alternative specimen type when cervical sampling is contraindicated or cannot otherwise be obtained.
For laboratory readers, the agreement matters because moving sample collection outside the clinic changes preanalytical controls, specimen logistics and patient-support requirements without removing the need for centralized laboratory processing. Quest will need to manage kit distribution, return shipping, specimen integrity, automated testing and results delivery across several ordering channels. The companies did not provide a specific launch date or volume forecast, and availability will begin during 2027.
Read the original Waters and Quest Diagnostics release, published Oct. 20, 2026.
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