Beginning in 2027, Quest Diagnostics will offer at-home sample collection for HPV screening, with laboratory testing that identifies individual high-risk HPV types to help guide patient care.
Quest Diagnostics and Waters Corp have formed a collaboration to expand access to at-home cervical cancer screening across the US using the FDA-cleared Onclarity Self-Collection Kit.
The initiative marks the first collaboration established by Waters to distribute the self-collection kit across clinical, health plan, and consumer-initiated channels, as well as Quest’s network of more than 2,000 patient service centers nationwide. Beginning in 2027, Quest will offer the testing option through clinician ordering, health insurance plan Gaps in Care programs, and its consumer platform, questhealth.com.
“In the US, there are over 24 million un- and under-screened individuals and approximately 14,000 new cases of cervical cancer each year,” says Jeff Andrews, MD, FRCSC, vice president of medical affairs, Waters Advanced Diagnostics, Waters Corp, in a release. “By bringing together Waters’ diagnostic innovation with Quest’s national reach and capabilities, we have an opportunity to make a meaningful impact for these millions of individuals who remain at risk, advancing our shared goal of eliminating this highly preventable disease.”
Automated High-Throughput Processing
Under the program, patients can collect their own cervical sample at home and return it by mail or drop it off at a Quest patient service center.
Quest’s laboratories will process the self-collected specimens using the BD Onclarity HPV Assay on the automated BD COR System. The instrument uses robotics to prepare, analyze, and report results while maintaining specimen integrity and analytical consistency across high-volume testing workflows.
“Many women struggle to participate in traditional cervical cancer screening methods, primarily due to geographic, socioeconomic, and logistical barriers,” says Damian Alagia, MD, senior medical director of women’s and reproductive health at Quest Diagnostics, in a release. “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.”
Extended Genotyping and Guideline Alignment
The BD Onclarity HPV Assay detects high-risk human papillomavirus genotypes and provides extended genotyping beyond the standard detection of HPV 16, 18, and 45. The assay individually identifies genotypes 16, 18, 31, 45, 51, and 52, alongside three sets of strategically pooled results, regardless of whether the specimen is clinician-collected or self-collected.
Genotype-specific data is increasingly relevant for clinical laboratories and clinicians managing post-vaccination patient populations. As widespread vaccination has driven down infection rates for HPV types 16 and 18, other high-risk genotypes account for an increasing proportion of cervical disease, particularly among younger cohorts.
The assay is the first FDA-approved HPV test to support all American Society for Colposcopy and Cervical Pathology Enduring Risk-Based Management Guidelines. In addition, updated Health Resources and Services Administration guidelines recommend high-risk HPV testing—utilizing either clinician collection or self-collection—as the preferred primary screening method for average-risk individuals aged 30 to 65.
The BD Biosciences and BD Diagnostic Solutions business units were acquired by Waters Corp, with Becton, Dickinson and Company remaining the legal manufacturer during the ongoing regulatory transfer period.
Photo caption: Onclarity Self-Collection Kit
Photo provided: Quest Diagnostics
