Flow Cytometry Tests Receive FDA Clearance for B-Cell Lymphoma Diagnosis

B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL), requires accurate identification to guide further evaluation, monitoring, and treatment. In 2026, an estimated 79,320 people in the U.S. will be diagnosed with NHL, including 22,760 CLL cases, and CLL is expected to cause about 4,350 deaths. Clinical flow cytometry in the U.S. has traditionally been laboratory-developed and institution-specific. A new innovation now advances standardized, ready-to-use flow cytometry testing for these blood cancers.

Waters Corporation (Milford, MA, USA) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test. The clearance enables commercialization in the U.S. for tests that aid pathologists and clinicians in identifying and diagnosing B-cell NHL, including CLL. The tests are available for preorder and are expected to be commercially available in the U.S. in spring 2027 through online ordering and local representatives.

The BD OneFlow Solution integrates reagents, instruments, defined staining protocols, pre-defined assay templates, and supporting consumables into a consistent recurring workflow. It is designed for immunophenotyping normal and abnormal cell populations. Compared with liquid reagent cocktails, the all-in-one solution significantly reduces hands-on time and is intended to improve workflow efficiency, support faster turnaround times, and lower the risk of human error.

According to an internal clinical study cited by Waters, the tests delivered 96.3% sensitivity and 98.2% specificity in identifying CLL. Internal Waters data comparing OneFlow assay tubes with liquid antibodies showed a 95% reduction in manual steps. The broader BD OneFlow portfolio is based on research and validation work from the EuroFlow Consortium, a collaborative effort focused on fast, highly sensitive flow cytometry tests for hematological malignancies.

The portfolio also includes tests supporting evaluation of multiple myeloma, acute lymphoblastic leukemia, and acute myeloid leukemia that have been available as CE-IVD reagents. Waters stated that this is the first FDA clearance from the broader BD OneFlow portfolio. The company said the clearance establishes a foundation for additional standardized tests for other blood cancers in the future.

“Clinical flow cytometry in the U.S. has traditionally been laboratory-developed and institution-specific. 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,” said Alexandra Kovach, M.D., Hematopathologist, Boston Children's Hospital.