Waters Corporation and Quest Diagnostics Expand Nationwide Access to At-Home HPV Screening to Help Close Cervical Cancer Screening Gaps
Waters Corporation, a global life sciences and diagnostics leader, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, have announced a collaboration designed to expand access to at-home cervical cancer screening across the United States. Announced on October 20, 2026, the partnership will make the FDA-cleared Onclarity™ Self-Collection Kit available through multiple healthcare and consumer channels, helping more individuals overcome barriers to routine screening.
The collaboration combines Waters Corporation’s diagnostic technology with Quest Diagnostics’ extensive national laboratory infrastructure, clinician relationships, health plan services, and patient service center network. Beginning in 2027, the companies plan to broaden access to a screening option that allows patients to collect their own samples at home while benefiting from advanced human papillomavirus (HPV) testing.
The initiative represents an important step toward addressing persistent cervical cancer screening gaps in the United States. By making sample collection more convenient and offering detailed HPV genotyping information, the companies aim to help individuals participate in screening and support appropriate follow-up care.
Expanding Access to At-Home Cervical Cancer Screening
Cervical cancer is largely preventable through regular screening, early detection, and appropriate medical follow-up. Persistent infection with high-risk HPV types is the leading cause of cervical cancer, making the identification of these infections an important part of preventive healthcare.
Despite the availability of screening technologies, millions of people remain unscreened or inadequately screened. Traditional screening approaches can present practical challenges, including discomfort associated with sample collection, limited access to healthcare facilities, geographic distance, financial considerations, and difficulties arranging appointments.
The collaboration between Waters and Quest is intended to address some of these challenges by expanding access to the Onclarity Self-Collection Kit for at-home use. The kit works with the BD Onclarity™ HPV Assay, which provides extended HPV genotyping information to support clinical assessment.
Jeff Andrews, M.D., FRCSC, Vice President of Medical Affairs at Waters Advanced Diagnostics, Waters Corporation, highlighted the scale of the screening challenge in the United States.
According to Andrews, more than 24 million individuals are unscreened or underscreened, while approximately 14,000 new cervical cancer cases occur annually. He explained that combining Waters’ diagnostic innovation with Quest’s national reach creates an opportunity to make a meaningful difference for individuals who remain at risk.
The companies’ shared objective is to help reduce preventable disease by making appropriate screening options more accessible to a broader population.
Quest Diagnostics to Provide Nationwide Access Through Multiple Channels
Starting in 2027, Quest Diagnostics plans to expand access to the Onclarity Self-Collection Kit through several established healthcare and consumer service channels.
These include its broad clinician channel, its Gaps in Care services for health insurance plans, its consumer-initiated testing platform, Quest Health, and its nationwide network of approximately 2,000 patient service centers.
This distribution strategy is designed to give patients and healthcare providers multiple ways to access the screening option. Clinicians can incorporate the service into appropriate patient care pathways, while health plans can use available channels to help address gaps in preventive screening. Consumers will also have access through Quest’s online platform
Quest Diagnostics serves approximately one in three American adults and one in two physicians and hospitals each year. Its extensive presence across the healthcare system gives the company an established platform for reaching individuals who might otherwise experience difficulties obtaining routine screening.
Damian (“Pat”) Alagia, M.D., a board-certified obstetrician-gynecologist and Senior Medical Director of Women’s & Reproductive Health at Quest Diagnostics, emphasized the importance of reducing barriers to care.
He noted that geographic, socioeconomic, and logistical challenges can prevent many women from participating in traditional cervical cancer screening. Alagia said the collaboration reflects the companies’ commitment to making healthcare more proactive, personal, and connected, including through at-home self-collection options that can help address gaps in access.
How the At-Home HPV Testing Process Works
The new offering is designed to make sample collection more convenient while retaining the laboratory testing infrastructure needed to analyze specimens and deliver results.
Under the planned process, patients will use the Onclarity Self-Collection Kit to collect their own samples at home. Once collection is complete, they can mail the sample back to Quest Diagnostics or drop it off at one of the company’s approximately 2,000 patient service centers nationwide.
Quest’s full-service laboratory will then process the samples using the BD COR™ System, a fully automated laboratory platform that incorporates advanced robotics to prepare and analyze specimens and report results.
Automation is intended to support consistent laboratory workflows, preserve specimen integrity, and facilitate reliable, high-quality testing outcomes. By combining at-home collection with centralized laboratory processing, the service aims to make the screening process more accessible without eliminating the role of professional diagnostic testing.
The approach also offers an alternative for individuals who face difficulties attending appointments for sample collection. However, patients should follow the kit’s instructions and applicable clinical guidance to ensure that testing is appropriate for their circumstances.
Extended HPV Genotyping Supports More Detailed Risk Assessment
A key feature of the Onclarity Self-Collection Kit and BD Onclarity HPV Assay combination is its extended HPV genotyping capability.
Different HPV types carry different levels of risk for cervical disease. HPV types 16, 18, and 45 are particularly important because they are associated with an increased risk of cervical cancer. Identifying specific high-risk genotypes can provide clinically relevant information to help healthcare professionals determine appropriate follow-up and management.
The BD Onclarity HPV Assay individually identifies six HPV types: 16, 18, 31, 45, 51, and 52. It also reports three strategically pooled groups of additional HPV types, providing a broader view of high-risk HPV infections.
This extended reporting approach is important because cervical disease can be associated with multiple high-risk HPV strains. Although vaccination has reduced infections caused by HPV types 16 and 18, other high-risk strains remain relevant to cervical cancer prevention, including among vaccinated populations.
Detailed genotype information can help clinicians assess risk and make decisions consistent with applicable clinical guidelines. Screening results alone, however, do not establish a diagnosis of cervical cancer, and the appropriate next steps depend on the individual’s results, medical history, and clinical circumstances.
The companies state that the BD Onclarity HPV Assay is the first and only FDA-approved HPV test supporting all American Society for Colposcopy and Cervical Pathology (ASCCP) Enduring Risk-Based Management Guidelines. The assay provides extended genotyping information regardless of the supported sample collection method.
Updated Screening Guidelines Reinforce the Importance of Access
The collaboration comes as healthcare guidance increasingly recognizes HPV testing as an important screening approach for eligible populations.
Updated Health Resources and Services Administration (HRSA) guidelines identify high-risk HPV testing, whether based on clinician-collected or self-collected samples, as the preferred screening method for average-risk individuals ages 30 to 65.
Expanding access to self-collection options could help eligible individuals participate in screening when traditional sample collection methods create barriers. At-home collection may be especially useful for people who have difficulty arranging appointments, live far from healthcare facilities, or prefer to collect samples in a more private setting.
Nevertheless, screening recommendations vary according to age, medical history, previous screening results, and individual risk factors. Patients should consult qualified healthcare professionals or follow applicable screening guidance to determine the most appropriate testing schedule and follow-up pathway.
By connecting at-home collection with laboratory testing and established healthcare channels, Waters and Quest aim to make it easier for more people to access screening services within the broader healthcare system.
Strengthening Women’s Health and Diagnostic Innovation
Quest Diagnostics already offers a broad range of solutions for women’s and reproductive health, including services supporting cervical cancer screening and diagnosis. The collaboration builds on this existing capability by adding another access route for HPV testing.
For Waters Corporation, the partnership highlights the role of advanced diagnostic technologies in addressing real-world healthcare challenges. Its Onclarity Self-Collection Kit, used with the BD Onclarity HPV Assay, is intended to combine convenient sample collection with detailed laboratory analysis.
The partnership also demonstrates how collaboration between diagnostic technology providers and national laboratory organizations can help bring innovations into broader clinical and consumer settings.
Source Link:https://ir.waters.com/
