Collaboration to Expand Cervical Cancer Screening Access With At-Home HPV Collection

Screening gaps persist, in part because traditional sample collection can be inaccessible and uncomfortable for patients. A newly expanded at-home screening option now aims to broaden access to clinically appropriate HPV testing nationwide while providing extended genotype information.

Waters Corporation (MIlford, MA, USA) and Quest Diagnostics (Secaucus, NJ, USA) have formed a collaboration to broaden access to the FDA-cleared Onclarity Self-Collection Kit. The kit is used with the BD Onclarity HPV Assay, an FDA-approved HPV test with comprehensive extended genotyping. Beginning in 2027, Quest will provide access through clinician, health plan, and consumer-initiated testing channels, along with its patient service center network.

With the self-collection option, patients can collect their own sample at home using the Onclarity Self-Collection Kit. Samples can then be mailed back to Quest or dropped off at one of approximately 2,000 Quest patient service centers nationwide. Quest’s full-service laboratory will process samples using the fully automated BD COR System, which uses advanced robotics to prepare, analyze, and report results while preserving specimen integrity.

The BD Onclarity HPV Assay is the first and only FDA-approved HPV test that supports all American Society for Colposcopy and Cervical Pathology (ASCCP) Enduring Risk-Based Management Guidelines. The assay individually identifies HPV types 16, 18, 31, 45, 51, and 52, along with three sets of strategically pooled results, regardless of collection method. Certain HPV genotypes, including types 16, 18, and 45, are associated with increased cervical cancer risk, making genotype-specific information important for patient management.

This is Waters’ first collaboration to provide access to the Onclarity Self-Collection Kit through clinical, health plan, consumer health, and patient service center channels in the United States. Quest serves one in three American adults and one in two physicians and hospitals each year.

“Many women struggle to participate in traditional cervical cancer screening methods, primarily due to geographic, socioeconomic, and logistical barriers. We believe in making healthcare more proactive, personal, and connected for all patients, including through transformational options like at-home self-collection to help fill critical gaps in access to care,” said Damian (“Pat”) Alagia, M.D., Senior Medical Director, Women’s & Reproductive Health, Quest Diagnostics.