Waters and Labcorp to Expand Access to Cervical Cancer Screening with the Most Comprehensive FDA-Approved HPV Testing Option Beginning in Late 2026
Labcorp plans to offer the testing through clinician programs, health plan programs and its consumer channel.
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Rhea-AI Summary
Labcorp (NYSE: LH) and Waters (NYSE: WAT) announced a partnership to expand access to FDA-approved HPV testing beginning in late 2026. The companies intend to offer the BD Onclarity HPV Assay through Labcorp's nationwide laboratory network by year-end, with clinician-collected and self-collected screening options in clinics, patient service centers and at home.
Labcorp will provide the testing through its clinician programs, Gaps in Care health plan programs and Labcorp OnDemand consumer channel. Its network serves more than 850,000 physicians and healthcare providers and includes more than 2,200 patient service centers. The assay identifies six HPV types individually and provides three grouped results for eight other types. The companies describe the collaboration as a way to address cervical cancer screening gaps.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Labcorp–Waters partnership will expand access to FDA-approved BD Onclarity HPV testing through Labcorp's nationwide network.
- Minor point. Forward-looking: it has not happened yet and may not happen.Late-2026 rollout is planned across clinician-collected and self-collected options in clinic, patient service center and at-home settings.
Negative
- Minor pointSelf-collected specimens are an alternative when cervical sampling is contraindicated or cervical samples cannot otherwise be obtained.
News Explained
Labcorp’s planned offer is not a transfer of regulatory responsibility: BD remains the assay’s legal manufacturer and responsible for regulatory obligations until required transfers are complete, so the release describes a future testing option while BD retains that interim role.
Key Figures
- Labcorp network reach
- More than 850,000 physicians and healthcare providers
- Network supporting the screening options
- Patient service centers
- More than 2,200
- Labcorp network
- High-risk HPV genotypes identified
- 6 genotypes
- BD Onclarity HPV Assay
- Moderate-risk HPV genotypes
- 3 pooled results for 8 genotypes
- BD Onclarity HPV Assay
- Planned offering
- By the end of 2026
- Labcorp and Waters intend to offer the assay
Key Terms
hpv medical
extended genotyping medical
fda-approved regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Labcorp intends to be the first commercial laboratory to offer FDA-approved HPV testing with the BD Onclarity™ HPV Assay across clinician-collected and self-collected screening options in clinic, patient service center, and at-home settings
- Through a network serving more than 850,000 physicians and healthcare providers and more than 2,200 patient service centers, Labcorp is helping expand access to cervical cancer screening nationwide
- First and only FDA-approved HPV test that supports all ASCCP Enduring Risk-Based Management Guidelines by providing comprehensive extended genotyping
Cervical cancer is largely preventable through routine screening and early detection of human papillomavirus (HPV), yet millions of women remain overdue for recommended tests. This collaboration is designed to help address persistent cervical cancer screening gaps by bringing more accessible screening options to patients across
"Barriers such as privacy, access, and socioeconomic factors can make it difficult to stay current with cervical cancer screening," said Jeff Andrews, M.D., FRCSC, Vice President of Medical Affairs, Waters Advanced Diagnostics, Waters Corporation.5-7 "We are at the start of a new era in which screening can extend beyond the clinic, enable more personalized risk assessment, and reach people who have historically been underserved. By offering greater flexibility in how and where people are screened, our collaboration marks a critical step forward in bridging one of today's most profound care gaps."
The Most Comprehensive FDA-Approved HPV Testing Option
The BD Onclarity HPV Assay is the only FDA-approved HPV test that supports all American Society for Colposcopy and Cervical Pathology (ASCCP) Enduring Risk-Based Management Guidelines.2,9
"Cervical cancer screening saves lives, but too many women still face barriers to getting screened," said Dr. Brian Caveney, Chief Medical and Scientific Officer, Labcorp. "By expanding access and options for comprehensive FDA-approved HPV testing, we can help more women stay current with recommended screening, reach those who may be overdue for care, and support earlier identification of cervical cancer risk."
Certain HPV genotypes, including types 16, 18 and 45, are associated with an increased risk of cervical cancer, making genotype-specific information important for patient management.9 As HPV vaccination has reduced infections from HPV types 16 and 18, other high-risk HPV strains now account for a growing share of cervical disease, particularly among younger, vaccinated populations.10 The BD Onclarity HPV Assay offers extended genotyping that individually identifies HPV types 16, 18, 31, 45, 51 and 52 along with three sets of strategically pooled results, regardless of collection method, making it the most comprehensive HPV screening tool available in the
Waters and Labcorp intend to offer the BD Onclarity HPV Assay by the end of 2026. To learn more, visit https://womenshealth.labcorp.com/providers/cervical-cancer-screening.
About Labcorp:
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 71,000 employees serve clients in approximately 100 countries, provided support for more than
About Waters Corporation:
Waters Corporation (NYSE: WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~15,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide. For more information, please visit www.waters.com/about.
Disclaimer:
The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation ("Waters"). Becton, Dickinson and Company or one of its affiliates or subsidiaries ("BD") remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD's regulatory authority. To learn more about the relationship between Waters and BD during this transition period, please see our detailed summary: www.waters.com/bdtransaction.
BD is a trademark of Becton, Dickinson and Company. Waters is a trademark of Waters Corporation or its affiliates. All other marks are the property of their respective owners. The BD Onclarity HPV Assay is manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries.
Cautionary Statement Regarding Forward-Looking Statements:
This press release contains forward-looking statements, including, but not limited to, statements with respect to Waters Corporation and Labcorp and its competitors' timing and ability to offer the BD Onclarity HPV Assay across various settings, and the anticipated benefits to patients of screening for cervical cancer using the BD Onclarity HPV Assay.
Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the control of Labcorp or Waters Corporation. These factors, in some cases, have affected and in the future (together with other factors) could affect the ability of Labcorp or Waters Corporation to implement its respective business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements. The forward-looking statements included in this release represent the companies' estimates or views as of the date of this release and should not be relied upon as representing the companies' estimates or views as of any date subsequent to the date of this release. Neither Labcorp nor Waters Corporation has any obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in each of Labcorp's and Waters Corporation's most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the headings RISK FACTORS and MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS, and in each of Labcorp's and Waters Corporation's other filings with the SEC.
References:
- All figures are for 2025, rounded.
- BD Onclarity™ HPV Assay US Package Insert [8089894].
- Okunade KS. Human papillomavirus and cervical cancer. J Obstet Gynaecol. 2020;40(5):602-608. doi:10.1080/01443615.2019.1634030.
- World Health Organization, Cervical Cancer Fact Sheet (updated 3 July 2026).
- Sk Abd Razak R, Amsah N, Heng PP, Jane Ling MY, Mohtar N, Masdor NA, Othman R, Hod R, Idris IB. Barriers and facilitators of cervical cancer screening among female healthcare. professionals: a systematic review. BMC Public Health. 2026. doi:10.1186/s12889-026-27501-2.
- U.S. Centers for Disease Control and Prevention. Cancer: Reducing Structural Barriers Planning Guide. Published May 21, 2024. Accessed April 30, 2026, at https://www.cdc.gov/cancer/php/ebi-planning-guides/reducing-structural-barriers-planning-guide.html.
- Farajimakin O. Barriers to Cervical Cancer Screening: A Systematic Review. Cureus. 2024;16(7):e65555. doi:10.7759/cureus.65555.
- Self-collected vaginal specimens can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained.
- Massad et al. Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines Journal of Lower Genital Tract Disease • Volume 00, Number 00, Month 2025.
- Wright TC Jr, Parvu V, Stoler MH, et al. HPV infections and cytologic abnormalities in vaccinated women 21-34 years of age.
- There are currently two FDA-approved HPV tests with extended genotyping with different configurations. The BD Onclarity™ HPV Assay individually identifies 6 high-risk HPV genotypes and strategically groups 3 results for 8 moderate risk HPV genotypes.
Contacts:
Molly Gluck
Director, Product and Thought Leadership Communications
Waters Corporation
+1.508.498.9732
molly_gluck@waters.com
Alissa Lawver
Executive Director, Business & Product Communications
Labcorp
media@labcorp.com
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SOURCE Waters Corporation; Labcorp
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When will Labcorp offer BD Onclarity HPV testing through the Waters partnership?
Labcorp and Waters intend to offer the BD Onclarity HPV Assay by the end of 2026, with access beginning in late 2026. Labcorp will provide the testing through its nationwide laboratory network.
Who can use self-collected specimens for Labcorp's BD Onclarity HPV testing?
Self-collected vaginal specimens can be tested as an alternative when cervical sampling is contraindicated or cervical samples otherwise cannot be obtained.
Who manufactures the BD Onclarity HPV Assay following Waters' acquisition of BD businesses?
Becton, Dickinson and Company or an affiliate or subsidiary manufactures the assay. BD remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed and retains responsibility for the legal manufacturer's regulatory obligations during that period.