The FDA clearances cover two tests for the identification and diagnosis of B-cell non-Hodgkin lymphoma, including chronic lymphocytic leukemia.
Waters Corporation announced that the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test have received US Food and Drug Administration (FDA) 510(k) clearance, allowing commercialization in the US. The ready-to-use flow cytometry tests are intended to aid in identifying and diagnosing B-cell non-Hodgkin lymphoma, including chronic lymphocytic leukemia.
The clearances are the first for the broader BD OneFlow portfolio and the latest development since Waters combined with BD’s Biosciences and Diagnostic Solutions businesses.
The BD OneFlow Solution brings together reagents, instruments, defined staining protocols, pre-defined assay templates, and supporting consumables in one recurring workflow for immunophenotyping normal and abnormal cell populations. According to Waters, the approach significantly reduces hands-on time compared with liquid reagent cocktails, which can help labs improve workflow efficiency, speed turnaround time, and lower the risk of human error.
Standardizing a Lab-Developed Field
Clinical flow cytometry in the US has historically relied on laboratory-developed, institution-specific methods. “Clinical flow cytometry in the US has traditionally been laboratory-developed and institution-specific,” says Alexandra Kovach, MD, hematopathologist at Boston Children’s Hospital, in a release. She adds that standardizing gating, analysis, and interpretation across sample types and diseases supports reproducibility, reliability, and confidence in results, and that flow cytometry-based IVD diagnostics are well positioned to add value to patient care.
Waters says the need is significant. An estimated 79,320 people in the US will be diagnosed with non-Hodgkin lymphoma in 2026, including 22,760 cases of chronic lymphocytic leukemia, which is expected to cause about 4,350 deaths. Chronic lymphocytic leukemia is the most common form of leukemia in adults, accounting for roughly one-third of new leukemia cases in the US.
“We want to reduce the complexity and variability that labs face in diagnosing disease,” says Steve Conly, senior vice president of Waters Biosciences at Waters Corporation, in a release. He says the clearance establishes a foundation for bringing additional standardized tests for other blood cancers to market.
EuroFlow Foundation and Availability
The BD OneFlow portfolio is built on research and validation work from the EuroFlow Consortium, a collaborative effort to develop fast, highly sensitive flow cytometry tests for diagnosing, classifying, and monitoring hematological malignancies. Within the portfolio, tests supporting evaluation of multiple myeloma, acute lymphoblastic leukemia, and acute myeloid leukemia have been available as CE-IVD reagents.
The BD OneFlow LST and BD OneFlow B-CLPD T1 Tests are available for preorder and are expected to be commercially available in the US in spring 2027 through online ordering and local representatives.
Waters notes that Becton, Dickinson and Company remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains responsibility for all regulatory obligations of the legal manufacturer.
Photo caption: BD OneFlow LST and BD OneFlow B-CLPD T1 tests have received FDA clearance.
Photo credit: Waters Corporation
