Waters Achieves FDA 510(k) Clearance for Ready-to-Use Flow Cytometry Clinical Tests for Leukemia and Lymphoma
Key Highlights
- ➤FDA clears BD OneFlow tests for U.S. commercialization in B-cell non-Hodgkin lymphoma
- ➤Tests deliver 96.3% sensitivity and 98.2% specificity identifying chronic lymphocytic leukemia
- ➤All-in-one solution reduces manual steps 95%, improving workflow efficiency and turnaround times
- ➤BD OneFlow tests available for preorder; U.S. commercial launch planned for spring 2027
Expert Statements
Alexandra Kovach, Hematopathologist, Boston Children’s Hospital
“Clinical flow cytometry in the U.S. has traditionally been laboratory-developed and institution-specific.”
Alexandra Kovach, 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.”
Alexandra Kovach, Hematopathologist, Boston Children’s Hospital
“For these reasons, flow cytometry-based IVD diagnostics are well positioned to bring significant value to patient care.”
Steve Conly, Senior Vice President, Waters Biosciences, Waters Corporation
“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.”
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.”
Waters Achieves FDA 510(k) Clearance for Ready-to-Use Flow Cytometry Clinical Tests for Leukemia and Lymphoma PR Newswire
* 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% specificity(1) 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)
Get started
Create a free account to read the full story.