Waters Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test, according to an announcement. The tests help with the identification and diagnosis of B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL).

The tests deliver 96.3% sensitivity and 98.2% specificity in identifying chronic lymphocytic leukemia (CLL), one of the most common types of NHL. They also reduce 95% of manual steps. The tests are results of the Waters-BD merger. 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. It 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, Waters says.

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.

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