- 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
MILFORD, Mass. and BURLINGTON, N.C., Oct. 23, 2026 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, and Waters Corporation (NYSE: WAT), a global life sciences and diagnostics leader, today announced a partnership to expand access to the FDA-approved BD Onclarity HPV Assay through Labcorp’s nationwide laboratory network beginning in late 2026.
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 the United States. Labcorp will provide these HPV testing options to support its clinician programs, Gaps in Care health plan programs, and Labcorp OnDemand consumer channel.2-8
“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 U.S. today.2,11
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 85% of the new drugs and therapeutic products approved by the FDA in 2025 and performed more than 750 million tests for patients around the world. Learn more at www.labcorp.com
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.
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
[email protected]
Alissa Lawver
Executive Director, Business & Product Communications
Labcorp
[email protected]
SOURCE Waters Corporation; Labcorp
Republished with credit to the original author. Read the original article.
