Waters Receives FDA Approval for Onclarity HPV Self-Collection Kit
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 08 2026
0mins
Should l Buy WAT?
Waters announced that the U.S. FDA has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use, marking a significant milestone in expanding access to cervical cancer screening, and removing barriers that currently prevent many individuals from receiving routine screening.
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Analyst Views on WAT
Wall Street analysts forecast WAT stock price to rise
13 Analyst Rating
8 Buy
5 Hold
0 Sell
Moderate Buy
Current: 335.610
Low
350.00
Averages
414.08
High
480.00
Current: 335.610
Low
350.00
Averages
414.08
High
480.00
About WAT
Waters Corporation is a global life sciences and diagnostics company. The Company offers analytical instruments, separations technologies, and software, serving life, materials, food, and environmental sciences. Its segments include Waters and TA. The Company primarily designs, manufactures, sells and services high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC and together with HPLC, referred to as LC) and mass spectrometry (MS) technology systems and support products, including chromatography columns, other consumable products and comprehensive post-warranty service plans. The Company designs, manufactures, sells and services thermal analysis, rheometry and calorimetry instruments through its TA Instruments (TA) product line. The Company is also a developer and supplier of advanced software-based products that interface with the Company’s instruments, as well as other manufacturers’ instruments.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Waters Corporation to Hold Q1 2026 Earnings Call on May 5
- Earnings Call Schedule: Waters Corporation will hold its Q1 2026 financial results conference call on May 5, 2026, at 8:30 a.m. Eastern Time, aimed at updating investors on the company's financial performance and outlook.
- Live Webcast Availability: The presentation will be available via live webcast on Waters' Investor Relations website, ensuring that global investors can access real-time financial information, thereby enhancing transparency and investor confidence.
- Replay Service: A replay of the webcast will be available until June 2, 2026, at midnight Eastern Time, allowing investors who cannot attend the live event to review the information, further improving accessibility to critical updates.
- Company Background: Waters Corporation is a global leader in life sciences and diagnostics, dedicated to accelerating scientific innovation through analytical technologies and informatics, showcasing its significant role in ensuring the release of high-quality medicines and food and water safety.
See More
Waters Launches omniDAWN™ Multi-Angle Light Scattering Photometer
- Technological Innovation: Waters Corporation's omniDAWN™ Multi-Angle Light Scattering Photometer features 18 detection angles, marking the first extended-range MALS detector for UHPLC and UPLC workflows, enabling size measurements from 50 nm to 500 nm, significantly enhancing the characterization of complex analytes.
- Efficiency Boost: When paired with UHPLC or UPLC systems, the photometer supports run times up to four times faster than conventional HPLC workflows, while reducing sample consumption by 30-50% and solvent use by approximately 40%, thereby improving laboratory efficiency and resource utilization.
- Data Quality Enhancement: The low dispersion design of the omniDAWN photometer preserves resolution and sensitivity, allowing for clearer differentiation between monomers, aggregates, and fragments, which supports scientists in making more informed decisions during drug discovery and development, accelerating the development of next-generation therapies.
- Software Integration: Powered by ASTRA™ Software, the device integrates MALS with UV and RI detection to enable comprehensive analysis of size, composition, and heterogeneity in a single run, compliant with 21 CFR Part 11 and EU Annex 11, and is expected to be available globally in summer 2026.
See More
Waters Corporation Launches At-Home Cervical Cancer Screening Tool
- FDA Approval for Self-Testing: The U.S. FDA has cleared Waters Corporation's Onclarity HPV Self-Collection Kit, which integrates with BD's Onclarity HPV Assay, aimed at enhancing accessibility and convenience for cervical cancer screening.
- High-Risk HPV Detection: The Onclarity HPV Assay detects all high-risk cancer-causing HPV genotypes and was approved by the FDA in 2024 for self-collection screening in healthcare settings, marking a significant advancement in cervical cancer prevention.
- Convenient Sample Processing: After collecting a cervical tissue sample, customers can mail the kit to a laboratory for processing, with results sent to their healthcare provider for follow-up, thereby improving screening efficiency.
- Strong Market Potential: Waters Corporation announced that the Onclarity HPV Self-Collection Kit will be available by prescription in the coming months, which is expected to drive growth in the cervical cancer screening market and further solidify its leadership in biosciences and diagnostic solutions.
See More
Waters Receives FDA Clearance for HPV Self-Collection Kit
- FDA Approval for Self-Collection Kit: Waters announced that its Onclarity HPV Self-Collection Kit has received FDA clearance, and when used with the BD Onclarity HPV Assay, it becomes the only FDA-approved HPV assay capable of identifying six individual results and three pooled results, enhancing accessibility for at-home testing.
- Nationwide Partnerships: The company is establishing partnerships to ensure nationwide availability of the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months, further facilitating convenient home health management.
- Automated Processing System: Samples will be processed on the fully automated BD COR System, which not only increases testing efficiency but also ensures result accuracy, thereby boosting consumer confidence in home self-testing.
- Positive Market Reaction: In pre-market trading on the NYSE, Waters shares rose by 2% to $313.53, reflecting market optimism regarding the launch of the new product and its potential market impact.
See More
Waters Corporation Launches At-Home HPV Self-Collection Kit
- FDA Approval Milestone: The FDA's clearance of Waters Corporation's Onclarity HPV Self-Collection Kit marks a significant milestone in expanding cervical cancer screening, expected to significantly increase screening rates and reduce the proportion of unscreened individuals, thereby lowering cervical cancer mortality.
- Comprehensive HPV Detection: The kit, tested with the BD Onclarity HPV Assay, detects all high-risk HPV genotypes, providing the most comprehensive screening solution available, which helps clinicians identify risks earlier and intervene sooner, improving patient health outcomes.
- Convenient Home Screening: The self-collection kit can be mailed directly to patients' homes via prescription, allowing them to collect samples at their convenience and send them back to the lab, which is expected to enhance accessibility to screening, especially for those unable to undergo regular screenings for various reasons.
- Promoting Health Equity: Waters Corporation aims to promote health equity through this innovative tool, with plans to establish partnerships for broader nationwide access, ultimately reducing the burden of cervical cancer on women and individuals with a cervix.
See More
Waters Corporation Launches HPV Self-Collection Tool
- FDA Approval: Waters Corporation announced that its Onclarity HPV Self-Collection Kit has received FDA clearance, marking a significant milestone in expanding cervical cancer screening in the U.S., which is expected to significantly increase screening rates and reduce cervical cancer risk.
- Increased Convenience: The kit allows patients to collect samples at home, addressing barriers faced by approximately 60% of unscreened or under-screened individuals, thereby promoting early detection and intervention, which enhances public health outcomes.
- Comprehensive Screening Capability: The Onclarity HPV Assay detects all high-risk HPV genotypes, making it the most comprehensive HPV screening tool available in the U.S. market, which is expected to improve clinicians' assessments of patient risks and subsequent care decisions.
- Nationwide Partnerships: Waters is establishing partnerships to enable the self-collection kit to be available by prescription in the coming months, expected to be covered by insurance, further promoting health equity and facilitating earlier detection.
See More
Waters Corporation to Hold Q1 2026 Earnings Call on May 5
- Earnings Call Schedule: Waters Corporation will hold its Q1 2026 financial results conference call on May 5, 2026, at 8:30 a.m. Eastern Time, aimed at updating investors on the company's financial performance and outlook.
- Live Webcast Availability: The presentation will be available via live webcast on Waters' Investor Relations website, ensuring that global investors can access real-time financial information, thereby enhancing transparency and investor confidence.
- Replay Service: A replay of the webcast will be available until June 2, 2026, at midnight Eastern Time, allowing investors who cannot attend the live event to review the information, further improving accessibility to critical updates.
- Company Background: Waters Corporation is a global leader in life sciences and diagnostics, dedicated to accelerating scientific innovation through analytical technologies and informatics, showcasing its significant role in ensuring the release of high-quality medicines and food and water safety.
See More
Waters Launches omniDAWN™ Multi-Angle Light Scattering Photometer
- Technological Innovation: Waters Corporation's omniDAWN™ Multi-Angle Light Scattering Photometer features 18 detection angles, marking the first extended-range MALS detector for UHPLC and UPLC workflows, enabling size measurements from 50 nm to 500 nm, significantly enhancing the characterization of complex analytes.
- Efficiency Boost: When paired with UHPLC or UPLC systems, the photometer supports run times up to four times faster than conventional HPLC workflows, while reducing sample consumption by 30-50% and solvent use by approximately 40%, thereby improving laboratory efficiency and resource utilization.
- Data Quality Enhancement: The low dispersion design of the omniDAWN photometer preserves resolution and sensitivity, allowing for clearer differentiation between monomers, aggregates, and fragments, which supports scientists in making more informed decisions during drug discovery and development, accelerating the development of next-generation therapies.
- Software Integration: Powered by ASTRA™ Software, the device integrates MALS with UV and RI detection to enable comprehensive analysis of size, composition, and heterogeneity in a single run, compliant with 21 CFR Part 11 and EU Annex 11, and is expected to be available globally in summer 2026.
See More
Waters Corporation Launches At-Home Cervical Cancer Screening Tool
- FDA Approval for Self-Testing: The U.S. FDA has cleared Waters Corporation's Onclarity HPV Self-Collection Kit, which integrates with BD's Onclarity HPV Assay, aimed at enhancing accessibility and convenience for cervical cancer screening.
- High-Risk HPV Detection: The Onclarity HPV Assay detects all high-risk cancer-causing HPV genotypes and was approved by the FDA in 2024 for self-collection screening in healthcare settings, marking a significant advancement in cervical cancer prevention.
- Convenient Sample Processing: After collecting a cervical tissue sample, customers can mail the kit to a laboratory for processing, with results sent to their healthcare provider for follow-up, thereby improving screening efficiency.
- Strong Market Potential: Waters Corporation announced that the Onclarity HPV Self-Collection Kit will be available by prescription in the coming months, which is expected to drive growth in the cervical cancer screening market and further solidify its leadership in biosciences and diagnostic solutions.
See More
Waters Receives FDA Clearance for HPV Self-Collection Kit
- FDA Approval for Self-Collection Kit: Waters announced that its Onclarity HPV Self-Collection Kit has received FDA clearance, and when used with the BD Onclarity HPV Assay, it becomes the only FDA-approved HPV assay capable of identifying six individual results and three pooled results, enhancing accessibility for at-home testing.
- Nationwide Partnerships: The company is establishing partnerships to ensure nationwide availability of the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months, further facilitating convenient home health management.
- Automated Processing System: Samples will be processed on the fully automated BD COR System, which not only increases testing efficiency but also ensures result accuracy, thereby boosting consumer confidence in home self-testing.
- Positive Market Reaction: In pre-market trading on the NYSE, Waters shares rose by 2% to $313.53, reflecting market optimism regarding the launch of the new product and its potential market impact.
See More
Waters Corporation Launches At-Home HPV Self-Collection Kit
- FDA Approval Milestone: The FDA's clearance of Waters Corporation's Onclarity HPV Self-Collection Kit marks a significant milestone in expanding cervical cancer screening, expected to significantly increase screening rates and reduce the proportion of unscreened individuals, thereby lowering cervical cancer mortality.
- Comprehensive HPV Detection: The kit, tested with the BD Onclarity HPV Assay, detects all high-risk HPV genotypes, providing the most comprehensive screening solution available, which helps clinicians identify risks earlier and intervene sooner, improving patient health outcomes.
- Convenient Home Screening: The self-collection kit can be mailed directly to patients' homes via prescription, allowing them to collect samples at their convenience and send them back to the lab, which is expected to enhance accessibility to screening, especially for those unable to undergo regular screenings for various reasons.
- Promoting Health Equity: Waters Corporation aims to promote health equity through this innovative tool, with plans to establish partnerships for broader nationwide access, ultimately reducing the burden of cervical cancer on women and individuals with a cervix.
See More
Waters Corporation Launches HPV Self-Collection Tool
- FDA Approval: Waters Corporation announced that its Onclarity HPV Self-Collection Kit has received FDA clearance, marking a significant milestone in expanding cervical cancer screening in the U.S., which is expected to significantly increase screening rates and reduce cervical cancer risk.
- Increased Convenience: The kit allows patients to collect samples at home, addressing barriers faced by approximately 60% of unscreened or under-screened individuals, thereby promoting early detection and intervention, which enhances public health outcomes.
- Comprehensive Screening Capability: The Onclarity HPV Assay detects all high-risk HPV genotypes, making it the most comprehensive HPV screening tool available in the U.S. market, which is expected to improve clinicians' assessments of patient risks and subsequent care decisions.
- Nationwide Partnerships: Waters is establishing partnerships to enable the self-collection kit to be available by prescription in the coming months, expected to be covered by insurance, further promoting health equity and facilitating earlier detection.
See More
