Waters receives FDA 510(k) clearance for BD OneFlow lymphoma diagnostic tests
Waters Corporation announced that its BD OneFlow LST and BD OneFlow B‑CLPD T1 flow cytometry tests have been cleared by the U.S. Food and Drug Administration under 510(k). The tests target B‑cell non‑Hodgkin lymphoma, including chronic lymphocytic leukemia, and are slated for U.S. commercial launch in spring 2027. Waters highlighted that the ready‑to‑use solution cuts manual steps and improves diagnostic consistency.
Why it matters
The clearance allows Waters to market the tests in the United States, opening a new revenue stream from standardized lymphoma diagnostics. Laboratories can expect faster turnaround and fewer errors, which may drive adoption and increase market share for Waters' diagnostics portfolio.
Key facts
- 1The BD OneFlow LST and BD OneFlow B‑CLPD T1 tests received FDA 510(k) clearance. prnewswire.com
- 2The tests deliver 96.3% sensitivity in identifying chronic lymphocytic leukemia. prnewswire.com
- 3The tests deliver 98.2% specificity in identifying chronic lymphocytic leukemia. prnewswire.com
- 4The solution reduces manual steps by 95% compared with previous methods. prnewswire.com
- 5The tests will be commercially available in the U.S. in spring 2027. prnewswire.com
- 6Clearance was announced on November 10, 2026. prnewswire.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.