Waters Announces FDA Clearance of the Most Comprehensive At-Home Cervical Cancer Screening Tool, the Onclarity HPV Self-Collection Kit and FDA-Approved HPV Assay

Rhea-AI Summary

Waters (NYSE: WAT) announced U.S. FDA clearance (April 8, 2026) of the Onclarity HPV Self-Collection Kit and FDA approval of the BD Onclarity HPV Assay for at-home use. The assay provides extended genotyping (six individual types, three pooled groups) and works with the automated BD COR System.

The kit aims to increase screening access for unscreened or under-screened individuals (about 60% of cervical cancer cases) and will be available by prescription in coming months, covered by private insurance, Medicaid, and Medicare.

Positive

• FDA clearance for at-home Onclarity HPV self-collection (April 8, 2026)
• Extended genotyping: six individual types plus three pooled groups
• Automated processing via BD COR System for high-throughput labs
• Expected coverage by private insurance, Medicaid, and Medicare

Negative

• Availability by prescription may delay immediate consumer access
• No explicit commercial rollout date; timing described as "coming months"

News Market Reaction – WAT

+3.63%

+3.63% Session close to close

In the Apr 8 session, WAT gained 3.63%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights FDA clearance of Waters’ Onclarity HPV Self‑Collection Kit and approval...

Analysis

This announcement highlights FDA clearance of Waters’ Onclarity HPV Self‑Collection Kit and approval of the BD Onclarity HPV Assay for at‑home use, targeting the roughly 60% of cervical cancer cases arising in unscreened or under‑screened individuals. It builds on the recent BD Biosciences & Diagnostic Solutions combination and product launches, set against BDS quarterly revenue of $766 million versus $834 million a year earlier. Investors may watch adoption, reimbursement coverage, and future financing steps under the active S‑3ASR shelf.

Key Figures

Unscreened case share: 60% of cervical cancer cases Senior notes offering: $3.5 billion BDS quarterly revenue: $766 million +5 more

8 metrics

Unscreened case share 60% of cervical cancer cases Portion occurring in unscreened or under-screened individuals cited in article

Senior notes offering $3.5 billion Augusta SpinCo senior notes issued to refinance delayed draw term loan

BDS quarterly revenue $766 million Three months ended Dec 31, 2025; down from $834M prior year

BDS prior revenue $834 million Three months ended Dec 31, 2024 comparator for BDS Business

BDS net income $49 million Three months ended Dec 31, 2025; down from $78M prior year

BDS FY25 revenue $3,296 million BD’s fiscal year 2025 worldwide revenues for BDS Business

Shares outstanding 98,101,871 shares Waters common stock issued and outstanding as of Feb 19, 2026 in S-3ASR

Insider tax withholding 302 shares at $304.09 Shares withheld from Jianqing Bennett RSU vesting to cover taxes

Historical Context

5 past events · Latest: Mar 18 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 18	Debt refinancing	Neutral	-0.7%	$3.5B senior notes via Augusta SpinCo to refinance term loan.
Mar 09	Product launch	Positive	+1.0%	Launch of ARES‑G3 Rheometer with up to 10x data rate improvement.
Feb 23	Conference appearance	Neutral	-0.5%	CEO fireside chat announced for TD Cowen Health Care Conference.
Feb 17	Product launch	Positive	-0.6%	New microflow LC columns with MaxPeak Premier Technology introduced.
Feb 09	Business combination	Neutral	-13.9%	Completion of BD’s BDS business combination with Waters.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent product launches showed mixed price reactions, while the large BD combination saw a notably negative move.

Recent Company History

Over the last few months, Waters has combined BD’s Biosciences & Diagnostic Solutions business, refinanced $3.5 billion of debt via Augusta SpinCo notes, and launched several next‑generation analytical products such as the ARES‑G3 Rheometer and MaxPeak Premier microflow LC columns. The BD combination on Feb 9, 2026 coincided with a -13.94% move, while recent product launches produced modest, mixed reactions. Today’s FDA clearance for the at‑home Onclarity HPV Self‑Collection Kit extends this diagnostics strategy into patient-facing screening.

Key Terms

hpv, genotypes, medicaid, medicare, +4 more

8 terms

hpv medical

"Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV)"

Human papillomavirus (HPV) is a family of common viruses that infect skin and mucous membranes; some types cause harmless warts while others can lead to precancerous changes and cancers such as cervical cancer. For investors, HPV matters because vaccines, diagnostic tests, screening programs, and treatments drive regulatory approvals, public health policy, and recurring revenue streams for healthcare companies—think of it as a prevalent health risk that creates ongoing demand for prevention and care products.

genotypes medical

"detects all of the high-risk, carcinogenic genotypes of HPV and is the only FDA-approved HPV assay"

A genotype is an organism’s genetic blueprint — the specific set of DNA instructions that determine traits and how the body responds to drugs or diseases. For investors, genotypes matter because companies use them to design targeted medicines, diagnostic tests and clinical trials; knowing which patient groups will benefit can speed approvals, reduce development costs and create niche markets, much like tailoring a product to a specific customer group.

medicaid regulatory

"Covered by private insurance, Medicaid, and Medicare, the kit can be mailed directly"

Medicaid is a government-funded health insurance program that provides medical coverage to low-income individuals, families, elderly people and people with disabilities, administered jointly by the federal government and state governments in the United States. For investors, Medicaid matters because changes in eligibility, funding, or payment rules can alter patient volume and the prices hospitals, nursing homes, insurers and medical suppliers receive—similar to how a large customer or contract can shift a company’s revenue outlook.

medicare regulatory

"Covered by private insurance, Medicaid, and Medicare, the kit can be mailed directly"

Medicare is a large government-run health insurance program that primarily covers people aged 65 and older and certain younger people with disabilities. For investors it matters because Medicare acts like a huge customer and rule-maker for hospitals, drugmakers and medical-device companies—its coverage decisions, payment rates and regulatory policies can change demand, revenue and profit margins across the healthcare sector, similar to how a major client or regulator can shape a business’s prospects.

nih medical

"Waters collaborated with the National Institutes of Health's (NIH) National Cancer Institute (NCI)"

The NIH is the U.S. government’s primary medical research agency that funds and conducts health-related studies, ranging from basic biology to clinical trials. For investors, NIH involvement can signal scientific credibility, potential grant funding, or faster progress on a drug or technology—similar to a trusted lab backing a new product—while also influencing regulatory attention and the perceived risk and value of health-sector companies.

national cancer institute medical

"collaborated with the National Institutes of Health's (NIH) National Cancer Institute (NCI)"

A national cancer institute is a government agency that leads, funds and coordinates a country’s cancer research, clinical trials and treatment guidance. Think of it as a central roadmap and financing office for cancer science: its studies, approvals and endorsements can speed or slow drug development, influence the design and funding of trials, and affect which therapies gain credibility with doctors and patients—outcomes that can materially change the prospects and value of healthcare companies.

obstetrician-gynecologist medical

"As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades"

An obstetrician-gynecologist is a physician who cares for women's reproductive health, pregnancy, childbirth and related surgical needs; think of them as a combined family doctor for pregnancy and a surgeon for reproductive system issues. Investors watch demand for their services because it drives revenue for hospitals, clinics, medical device makers and drug companies tied to women's health—much like a steady customer base influences sales for any supplier in an industry.

robotics technical

"BD COR System, which uses advanced robotics to prepare, analyze, and report results"

Robotics is the design, building and programming of machines that can perform physical tasks autonomously or with minimal human control, ranging from simple mechanical helpers to complex intelligent systems. For investors, robotics matters because these machines can boost productivity, cut operating costs, and create new markets much like adding a team of tireless, precise workers; companies that develop or adopt robotics can gain competitive advantages and shift future revenue and expenses.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• FDA-approved BD Onclarity™ HPV Assay is the most comprehensive screening tool for HPV in the U.S.^1,4 with extended genotyping and end-to-end automated lab workflows.
• At-home self-collection reduces significant barriers for unscreened or under-screened individuals who make up approximately 60% of cervical cancer cases.³
• Waters is establishing partnerships to enable broader nationwide access to the Onclarity™ HPV Self-Collection Kit for patients and prescribers to reduce cervical cancer risk.

MILFORD, Mass., April 8, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that the U.S. Food and Drug Administration (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.

Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV), the virus responsible for nearly all cervical cancers.² Approximately 60% of cervical cancer cases occur in individuals who are unscreened or under-screened.³ Expanding screening options and access, including at-home self-collection, has been identified by public health experts as an instrumental strategy for improving early detection and reducing cervical cancer deaths.

"Expanding access to screening is one of the most important steps we can take to prevent cervical cancer, and at-home HPV self-collection is a game changer for making screening easier to complete," said Jeff Andrews, M.D., FRCSC, Vice President of Medical Affairs, Waters Advanced Diagnostics, Waters Corporation. "As a practicing obstetrician-gynecologist who has performed cervical cancer screenings for decades, I have seen firsthand the profound difference early detection makes for patients. When more patients are able to get screened, whether at home or in the clinic, clinicians have better information to identify risks earlier and intervene sooner. That allows us to spend less time trying to reach patients who have fallen behind on screening and more time focusing on prevention, follow-up care, and treatment for those who need it."

The kit is tested with the BD Onclarity HPV Assay, which detects all of the high-risk, carcinogenic genotypes of HPV and is the only FDA-approved HPV assay to identify six individually and three groups of pooled results, making it the most comprehensive HPV screening tool available in the U.S. today.¹ Samples are processed on the fully automated BD COR™ System, which uses advanced robotics to prepare, analyze, and report results while preserving specimen integrity and ensuring reliable, high-quality outcomes. Waters collaborated with the National Institutes of Health's (NIH) National Cancer Institute (NCI) through the Cervical Cancer 'Last Mile' Initiative SHIP Trial to evaluate the accuracy of self-collection for HPV testing.

"U.S. FDA clearance of the Onclarity Self-Collection Kit for at-home use marks a meaningful step towards removing today's primary barriers to screening, and supporting more personalized care," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "We're proud to provide this kit to advance earlier detection, achieve greater health equity, and ultimately reduce the burden of cervical cancer for women and persons with a cervix."

Waters is currently establishing partnerships to enable broader nationwide access to the Onclarity HPV Self-Collection Kit, which is expected to be available by prescription in the coming months. Covered by private insurance, Medicaid, and Medicare, the kit can be mailed directly to a patient's home, allowing them to collect a sample at their convenience and mail it to a laboratory for processing. Results are shared with the patient's healthcare provider to guide follow-up and care decisions.

Additional Resources:

• Product Page

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 Onclarity HPV Self-Collection Kit, Onclarity HPV Assay, and BD COR System are manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries.  

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 ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide. For more information, please visit www.waters.com/about.

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:

1. BD Onclarity HPV Assay Package Insert [8089894].
2. World Health Organization. (2026, March 17). Cervical Cancer. https://www.who.int/news-room/fact-sheets/detail/cervical-cancer.
3. Scarinci IC, Garcia FA, Kobetz E, Partridge EE, Brandt HM et al. (2010) Cervical cancer prevention: new tools and old barriers. Cancer 116 (11): 2531-2542.
4. Wei F, Georges D, Man I, Baussano I, Clifford GM. Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. Lancet. 2024;404(10451):435‑444. doi:10.1016/S0140-6736(24)01097-3.

Contact:

Molly Gluck
Head of External Communications
Waters Corporation
+1.508.498.9732
molly_gluck@waters.com

 

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SOURCE Waters Corporation

FAQ

What did Waters (WAT) announce on April 8, 2026 about the Onclarity HPV Self-Collection Kit?

Waters announced FDA clearance of the Onclarity HPV Self-Collection Kit and FDA approval of the BD Onclarity HPV Assay for at-home use. According to the company, the kit enables at-home sample collection, mail-in testing, and results reported to providers to guide follow-up care.

How comprehensive is the BD Onclarity HPV Assay approved for at-home use (WAT)?

The assay identifies six HPV genotypes individually and three groups of pooled results, making it highly comprehensive. According to the company, extended genotyping helps clinicians better stratify patient risk and prioritize follow-up based on specific HPV types detected.

When will the Onclarity HPV Self-Collection Kit from Waters (WAT) be available to patients?

The kit is expected to be available by prescription in the coming months after April 8, 2026. According to the company, Waters is establishing partnerships nationwide to enable distribution and provider access before commercial availability.

Will insurance cover the Waters Onclarity at-home HPV kit (WAT)?

Yes, the kit is reported to be covered by private insurance, Medicaid, and Medicare. According to the company, coverage should allow the kit to be mailed to patients' homes with results shared with their healthcare providers.

How could FDA clearance of the Onclarity self-collection kit affect cervical cancer screening rates for WAT-related products?

FDA clearance may increase access and uptake of screening among unscreened populations who account for about 60% of cases. According to the company, at-home self-collection reduces barriers and supports earlier detection and follow-up care.