Waters Achieves FDA 510(k) Clearance for Ready-to-Use Flow Cytometry Clinical Tests for Leukemia and Lymphoma

U.S. commercialization is cleared, with preorders open ahead of planned commercial availability in spring 2027.

Rhea-AI Summary

Waters (NYSE: WAT) received FDA 510(k) clearance for two BD OneFlow tests that aid identification and diagnosis of B-cell non-Hodgkin lymphoma. The BD OneFlow LST and BD OneFlow B-CLPD T1 tests cover chronic lymphocytic leukemia (CLL), among other B-cell non-Hodgkin lymphomas. Clearance enables U.S. commercialization; preorders are available, with commercial availability scheduled for spring 2027.

An internal clinical study reported 96.3% sensitivity and 98.2% specificity for identifying CLL, measuring detection of disease and correct identification of its absence, respectively. Waters reports that the solution reduces manual steps by 95% compared with liquid antibodies. Following Waters' acquisition of BD's Biosciences and Diagnostic Solutions businesses, BD remains the legal manufacturer until required regulatory transfers are completed.

2 points · 0 major

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointFDA 510(k) clearance enables U.S. commercialization of BD OneFlow LST and B-CLPD T1 tests.
• Minor point. Forward-looking: it has not happened yet and may not happen.Preorders are available, with U.S. commercial availability scheduled for spring 2027.

Negative

• Minor pointRequired regulatory transfers remain pending; BD continues as legal manufacturer until completion.

Key Figures

FDA clearance: 510(k) clearance Sensitivity: 96.3% Specificity: 98.2% +2 more

FDA clearance

510(k) clearance

U.S. clearance for two flow cytometry tests

Sensitivity

96.3%

Identifying chronic lymphocytic leukemia

Specificity

98.2%

Identifying chronic lymphocytic leukemia

Manual steps reduction

95%

All-in-one solution

U.S. commercial availability

Spring 2027

Tests available for preorder

Key Terms

510(k), flow cytometry, immunophenotyping, ce-ivd

4 terms

510(k) regulatory

"have received U.S. Food and Drug Administration (FDA) 510(k) clearance"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

flow cytometry technical

"ready-to-use flow cytometry testing solution"

A laboratory method that uses lasers and sensors to count and analyze individual cells or tiny particles as they flow past a detector, like a high‑speed supermarket scanner that reads barcodes on each item. Investors care because flow cytometry is widely used in drug development, diagnostics and manufacturing quality control; demand for the instruments, reagents and services can signal progress in clinical programs, recurring revenue streams and adoption of new therapies or tests.

immunophenotyping medical

"workflow for immunophenotyping normal and abnormal cell populations"

Immunophenotyping is a lab method that identifies and counts different types of immune cells by detecting unique proteins on their surfaces, like reading name tags on cells. For investors, it matters because it helps developers show which patients are likely to benefit, track whether a therapy is hitting its target, and spot safety issues early—information that can reduce clinical trial risk and guide commercial prospects.

ce-ivd regulatory

"have been available as CE-IVD reagents"

CE‑IVD is the European conformity mark showing that an in vitro diagnostic device — a medical test used on samples like blood or tissue — meets the EU’s safety and performance requirements for sale. For investors, it’s like a stamped passport that opens access to EU markets, signaling lower regulatory risk, broader commercial potential, and a clearer path to revenue for companies that make diagnostic tests.

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• BD OneFlow™ LST and BD OneFlow™ B-CLPD T1 Tests now FDA 510(k)-cleared in U.S. for identifying B-cell non-Hodgkin lymphoma (NHL)
• Delivers 96.3% sensitivity and 98.2% specificity¹ in identifying chronic lymphocytic leukemia (CLL), one of the most common types of NHL
• All-in-one solution reduces 95% of manual steps,² delivering workflow efficiency, fast turnaround times, and a reduction in errors

MILFORD, Mass., Nov. 10, 2026 /PRNewswire/ -- Waters Corporation (NYSE: WAT) today announced that the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test have received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance enables commercialization in the U.S. and provides pathologists and clinicians a standardized, ready-to-use flow cytometry testing solution that aids in identification and diagnosis of B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL), for faster and reliable diagnostic insights.²

The latest in a series of innovations delivered since Waters combined with BD's Biosciences & Diagnostic Solutions Businesses, the BD OneFlow Solution integrates reagents, instruments, defined staining protocols, pre-defined assay templates, and supporting consumables into a consistent, recurring workflow for immunophenotyping normal and abnormal cell populations. The solution significantly reduces hands-on time compared to liquid reagent cocktails, helping labs increase workflow efficiency, speed turnaround time, and lower the risk of human error.

"Clinical flow cytometry in the U.S. has traditionally been laboratory-developed and institution-specific," said Alexandra Kovach, M.D., Hematopathologist, Boston Children's Hospital. "Standardization of gating, analysis, and interpretation of flow cytometry data across sample types and diseases provide reproducibility, reliability, and confidence in the results for patients and their providers in our increasingly fragmented health care system. For these reasons, flow cytometry-based IVD diagnostics are well positioned to bring significant value to patient care."

In 2026, an estimated 79,320 people in the U.S. will be diagnosed with NHL, including 22,760 cases of CLL, which is expected to cause approximately 4,350 deaths.³ CLL is the most common form of leukemia in adults, accounting for approximately one-third of new leukemia cases in the U.S.³ Expanding access to accurate, standardized diagnostic testing can help pathologists and clinicians identify disease and determine the appropriate path for further evaluation, monitoring, and treatment.

"Marking the first FDA clearance from the broader BD OneFlow portfolio, the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test represent an important step toward making reliable, high-quality flow cytometry diagnostics for blood cancers more accessible to U.S. laboratories and the patients they serve," said Steve Conly, Senior Vice President, Waters Biosciences, Waters Corporation. "We want to reduce the complexity and variability that labs face in diagnosing disease, and this clearance establishes a foundation for bringing additional standardized tests to other blood cancers in the future."

The broader BD OneFlow portfolio is comprised of tests built on the research and validation work of the EuroFlow™ Consortium, a collaborative research effort to develop fast, highly sensitive flow cytometry tests for diagnosis, classification, and monitoring of hematological malignancies. Within this portfolio, tests supporting the evaluation of other blood cancers including multiple myeloma (MM), acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML) have been available as CE-IVD reagents.

The BD OneFlow LST and BD OneFlow B-CLPD T1 Tests are available for preorder and will be commercially available in the U.S. in spring 2027 through online ordering and local representatives.

For more information, please visit www.bdbiosciences.com/oneflow-us.

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.

Additional Resources:

• Product Page: www.bdbiosciences.com/oneflow-us

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:

1. Internal clinical study.
2. Internal Waters Data from internal study comparing OneFlow assay tubes with liquid antibodies.
3. NIH Cancer Stat Facts: Leukemia - Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin Lymphoma.

Contact:

Molly Gluck
Director, Product and Thought Leadership Communications
Waters Corporation
+1.508.498.9732
pr@waters.com

 

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SOURCE Waters Corporation

FAQ

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Which Waters BD OneFlow tests received FDA clearance?

The BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test received FDA 510(k) clearance. They aid identification and diagnosis of B-cell non-Hodgkin lymphoma, including chronic lymphocytic leukemia, and the clearance enables commercialization in the United States.

When will Waters' FDA-cleared BD OneFlow tests be available in the U.S.?

The tests are available for preorder, with U.S. commercial availability scheduled for spring 2027. They will be available through online ordering and local representatives.