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Waters Gains FDA Clearance for Flow Cytometry Tests for Blood Cancers
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Key Takeaways
Waters secured FDA clearance for two flow cytometry tests to help diagnose B-cell NHL, including CLL.
WAT's tests deliver 96.3% sensitivity and 98.2% specificity for CLL, with a U.S. launch set for spring 2027.
The BD OneFlow solution cuts manual steps by about 95%, improving lab efficiency and diagnostic consistency.
Waters (WAT - Free Report) recently received FDA 510(k) clearance for its BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test, enabling their commercialization in the United States. The ready-to-use flow cytometry tests are designed to aid in identifying and diagnosing B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL). The solution offers standardized diagnostic workflows, delivering 96.3% sensitivity and 98.2% specificity in identifying CLL.
Per management, the FDA clearance marks an important milestone in expanding access to reliable, high-quality flow cytometry diagnostics for blood cancers. The company aims to simplify diagnostic procedures and minimize variability across laboratories while establishing a foundation for introducing standardized tests for additional blood cancers in the future.
The clearance is significant given the prevalence of blood cancers in the United States. An estimated 79,320 people are expected to be diagnosed with NHL in 2026, including 22,760 cases of CLL. The BD OneFlow LST and BD OneFlow B-CLPD T1 Tests are currently open for preorders and are expected to launch commercially in the United States in spring 2027 through online channels and local sales representatives.
WAT Stock Trend Following the News
Following the announcement, shares of WAT rose 2.9% at yesterday’s close. Year to date, the stock jumped 25.2%, outperforming the industry’s 4.7% growth and the S&P 500’s 8.8% rise.
The FDA clearance provides WAT with an opportunity to strengthen its presence in the growing clinical diagnostics market and broaden the commercial reach of its Biosciences business. The introduction of standardized, ready-to-use tests could encourage wider adoption among clinical laboratories seeking to improve testing productivity and diagnostic consistency. Expansion of the BD OneFlow portfolio into other blood cancers could create additional revenue opportunities, allowing WAT to strengthen its presence in the growing hematology diagnostics market.
WAT currently has a market capitalization of $46.83 billion.
Image Source: Zacks Investment Research
More on BD OneFlow Flow Cytometry Tests
The BD OneFlow solution combines reagents, instruments, defined staining protocols, preconfigured assay templates and supporting consumables into a standardized workflow. By reducing manual steps by approximately 95% compared with conventional liquid reagent cocktails, the solution helps laboratories improve operational efficiency, accelerate turnaround times and minimize the likelihood of human errors.
The BD OneFlow portfolio builds on the research and validation work of the EuroFlow Consortium, a collaborative initiative focused on developing sensitive and efficient flow cytometry tests for diagnosing, classifying and monitoring blood cancers. Flow cytometry helps identify and characterize normal and abnormal cell populations by examining their physical and molecular characteristics.
The tests are designed to bring greater consistency to clinical flow cytometry, which has traditionally relied on laboratory-developed protocols and institution-specific testing procedures. Beyond NHL and CLL, the broader portfolio includes tests supporting the evaluation of multiple myeloma (MM), acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), which are currently available as CE-IVD reagents. This provides WAT with scope to pursue further regulatory clearances and expand its clinical diagnostics offerings across hematological malignancies.
Industry Prospects Favoring the Market
According to Grand View Research, the global flow cytometry market is estimated to reach $5.4 billion in 2026 and is projected to witness a CAGR of 6% through 2033.
Factors such as the rising prevalence of blood cancers and other hematological disorders, growing demand for accurate disease diagnosis and monitoring, increasing adoption of advanced clinical testing solutions and technological advancements in flow cytometry are driving market growth.
Other News
Waters recently launched AI-Powered Peak Integration for its Empower Software, automating chromatography data processing in regulated laboratories. The AI-powered capability is expected to reduce manual interventions by up to 95%, improve accuracy by 76% and lower user-to-user variability by 72%. Early access is expected in December 2026.
Waters also launched AI Link, integrating Anthropic’s Model Context Protocol into its waters_connect software to enable AI-driven laboratory workflows. The technology allows scientists to control instruments using AI agents, automate experiments and accelerate research and development, with workflows extending into regulated environments.
Some top-ranked stocks from the broader medical space are Glaukos (GKOS - Free Report) , Intuitive Surgical (ISRG - Free Report) and West Pharmaceutical Services (WST - Free Report) .
Glaukos, currently flaunting a Zacks Rank #1 (Strong Buy), reported third-quarter 2026 adjusted earnings per share (EPS) of 47 cents, which surpassed the Zacks Consensus Estimate by 491.7%. Revenues of $211 million beat the Zacks Consensus Estimate by 25%. You can see the complete list of today’s Zacks #1 Rank stocks here.
GKOS has an estimated earnings growth rate of 155.6% for 2026. The company’s earnings beat estimates in three of the trailing four quarters and missed once, the average surprise being 138.6%.
Intuitive Surgical, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2026 adjusted EPS of $3.00, which beat the Zacks Consensus Estimate by 13.6%. Revenues of $3.05 billion surpassed the Zacks Consensus Estimate by 4.9%.
Intuitive Surgical has a long-term estimated growth rate of 15.5%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.1%.
West Pharmaceutical, currently carrying a Zacks Rank #2, reported a third-quarter 2026 adjusted EPS of $2.66, which surpassed the Zacks Consensus Estimate by 22%. Revenues of $874.5 million beat the Zacks Consensus Estimate by 5.9%.
WST has an estimated long-term earnings growth rate of 17.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 18.6%.
View the Zacks #1 Rank List
Image: Bigstock
Waters Gains FDA Clearance for Flow Cytometry Tests for Blood Cancers
Key Takeaways
Waters (WAT - Free Report) recently received FDA 510(k) clearance for its BD OneFlow LST Test and BD OneFlow B-CLPD T1 Test, enabling their commercialization in the United States. The ready-to-use flow cytometry tests are designed to aid in identifying and diagnosing B-cell non-Hodgkin lymphoma (NHL), including chronic lymphocytic leukemia (CLL). The solution offers standardized diagnostic workflows, delivering 96.3% sensitivity and 98.2% specificity in identifying CLL.
Per management, the FDA clearance marks an important milestone in expanding access to reliable, high-quality flow cytometry diagnostics for blood cancers. The company aims to simplify diagnostic procedures and minimize variability across laboratories while establishing a foundation for introducing standardized tests for additional blood cancers in the future.
The clearance is significant given the prevalence of blood cancers in the United States. An estimated 79,320 people are expected to be diagnosed with NHL in 2026, including 22,760 cases of CLL. The BD OneFlow LST and BD OneFlow B-CLPD T1 Tests are currently open for preorders and are expected to launch commercially in the United States in spring 2027 through online channels and local sales representatives.
WAT Stock Trend Following the News
Following the announcement, shares of WAT rose 2.9% at yesterday’s close. Year to date, the stock jumped 25.2%, outperforming the industry’s 4.7% growth and the S&P 500’s 8.8% rise.
The FDA clearance provides WAT with an opportunity to strengthen its presence in the growing clinical diagnostics market and broaden the commercial reach of its Biosciences business. The introduction of standardized, ready-to-use tests could encourage wider adoption among clinical laboratories seeking to improve testing productivity and diagnostic consistency. Expansion of the BD OneFlow portfolio into other blood cancers could create additional revenue opportunities, allowing WAT to strengthen its presence in the growing hematology diagnostics market.
WAT currently has a market capitalization of $46.83 billion.
Image Source: Zacks Investment Research
More on BD OneFlow Flow Cytometry Tests
The BD OneFlow solution combines reagents, instruments, defined staining protocols, preconfigured assay templates and supporting consumables into a standardized workflow. By reducing manual steps by approximately 95% compared with conventional liquid reagent cocktails, the solution helps laboratories improve operational efficiency, accelerate turnaround times and minimize the likelihood of human errors.
The BD OneFlow portfolio builds on the research and validation work of the EuroFlow Consortium, a collaborative initiative focused on developing sensitive and efficient flow cytometry tests for diagnosing, classifying and monitoring blood cancers. Flow cytometry helps identify and characterize normal and abnormal cell populations by examining their physical and molecular characteristics.
The tests are designed to bring greater consistency to clinical flow cytometry, which has traditionally relied on laboratory-developed protocols and institution-specific testing procedures. Beyond NHL and CLL, the broader portfolio includes tests supporting the evaluation of multiple myeloma (MM), acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), which are currently available as CE-IVD reagents. This provides WAT with scope to pursue further regulatory clearances and expand its clinical diagnostics offerings across hematological malignancies.
Industry Prospects Favoring the Market
According to Grand View Research, the global flow cytometry market is estimated to reach $5.4 billion in 2026 and is projected to witness a CAGR of 6% through 2033.
Factors such as the rising prevalence of blood cancers and other hematological disorders, growing demand for accurate disease diagnosis and monitoring, increasing adoption of advanced clinical testing solutions and technological advancements in flow cytometry are driving market growth.
Other News
Waters recently launched AI-Powered Peak Integration for its Empower Software, automating chromatography data processing in regulated laboratories. The AI-powered capability is expected to reduce manual interventions by up to 95%, improve accuracy by 76% and lower user-to-user variability by 72%. Early access is expected in December 2026.
Waters also launched AI Link, integrating Anthropic’s Model Context Protocol into its waters_connect software to enable AI-driven laboratory workflows. The technology allows scientists to control instruments using AI agents, automate experiments and accelerate research and development, with workflows extending into regulated environments.
Waters Corporation Price
Waters Corporation price | Waters Corporation Quote
WAT’s Zacks Rank & Key Picks
Currently, Waters carries a Zacks Rank #3 (Hold).
Some top-ranked stocks from the broader medical space are Glaukos (GKOS - Free Report) , Intuitive Surgical (ISRG - Free Report) and West Pharmaceutical Services (WST - Free Report) .
Glaukos, currently flaunting a Zacks Rank #1 (Strong Buy), reported third-quarter 2026 adjusted earnings per share (EPS) of 47 cents, which surpassed the Zacks Consensus Estimate by 491.7%. Revenues of $211 million beat the Zacks Consensus Estimate by 25%. You can see the complete list of today’s Zacks #1 Rank stocks here.
GKOS has an estimated earnings growth rate of 155.6% for 2026. The company’s earnings beat estimates in three of the trailing four quarters and missed once, the average surprise being 138.6%.
Intuitive Surgical, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2026 adjusted EPS of $3.00, which beat the Zacks Consensus Estimate by 13.6%. Revenues of $3.05 billion surpassed the Zacks Consensus Estimate by 4.9%.
Intuitive Surgical has a long-term estimated growth rate of 15.5%. ISRG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.1%.
West Pharmaceutical, currently carrying a Zacks Rank #2, reported a third-quarter 2026 adjusted EPS of $2.66, which surpassed the Zacks Consensus Estimate by 22%. Revenues of $874.5 million beat the Zacks Consensus Estimate by 5.9%.
WST has an estimated long-term earnings growth rate of 17.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 18.6%.