Industry News & Literature
Stay ahead with expert-curated flow cytometry & cell/gene therapy news, landmark publications (including OMICs),
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Featured Industry News
Handpicked headlines in flow cytometry & cell/gene therapy. Non-members see a preview; members get the full feed.
July 15, 2025 – Flow Cytometry
Waters to Acquire BD’s Biosciences & Diagnostic Solutions (incl. Flow Cytometry) in a $17.5B Reverse Morris Trust
A transformative deal that would shift one of the largest U.S. flow cytometry portfolios (BD Biosciences) into Waters, reshaping competitive dynamics across instruments, reagents, and service; completion targeted for early 2026.
May 30, 2025 – Flow Cytometry
Cytek Introduces Aurora™ Evo Full-Spectrum Flow Cytometer
Cytek’s new flagship advances its Full Spectrum Profiling™ platform (greater sensitivity/throughput and workflow enhancements), strengthening its position in U.S. multi-color immunophenotyping and CGT applications.
May 29, 2025 – Flow Cytometry
Thermo Fisher Launches New Spectral Flow Cytometer
Thermo Fisher unveiled a next-gen spectral system aimed at higher-color panels, faster run times, and lower sample volumes—heightening competition in U.S. spectral cytometry for research and translational labs.
July 11, 2025 – Flow Cytometry/CGT
CMS Issues Enforcement Discretion on Certain CLIA Personnel Requirements
Federal flexibility on CLIA personnel standards may ease staffing constraints for U.S. clinical labs (including flow labs), with policy nuances affecting hiring/qualification pathways.
June 27, 2025 – CGT
FDA Eliminates REMS for Autologous CAR-T Immunotherapies
FDA removed the REMS requirement for all approved BCMA- and CD19-directed autologous CAR-T products, citing sufficient labeling and clinical experience to manage CRS/ICANS risks.
January 2025 – Flow Cytometry
CLSI H62: Update of Validation of Cell-Based Assays Performed by Flow Cytometry
This consensus standard, recognized by the FDA in 2025, provides detailed guidance for validating flow cytometry–based assays, including assay design, instrument setup, quality control, and performance characteristics (accuracy, precision, specificity, sensitivity, and linearity). It is particularly relevant for laboratories supporting clinical trials, diagnostic applications, and cell/gene therapy QC.
Curated Literature Highlights
2020-07-15 – Cytometry Part A
OMIP-069: 40-Color Full-Spectrum Flow Cytometry Panel for Deep Immunophenotyping of Major Cell Subsets of the Human Peripheral Blood
What it is: A community-adopted, 40-color spectral panel and workflow that unlocked routine, high-parameter immunophenotyping on full-spectrum instruments.
Why landmark (metrics): Cited well over 100 times (PubMed shows “Cited by” >300); method has become a go-to reference for building large spectral panels across core facilities.
2021-12-02 – Blood
2021 Update on MRD in Acute Myeloid Leukemia: A Consensus Document From the European LeukemiaNet MRD Working Party
What it is: The global standard-setting MRD guideline integrating flow cytometry (and molecular) with thresholds, time points, and reporting rules used in trials and clinical care.
Why landmark (metrics): Cited >600 times and directly drives assay design/interpretation and clinical decisions worldwide; widely implemented by hospital and reference labs.
2021-09-20 – Cytometry Part A
Full Spectrum Flow Cytometry as a Powerful Technology for Cancer Immunotherapy Research
What it is: A practice-oriented review that codified best practices for spectral instrumentation, panel design, unmixing, and analysis in immuno-oncology.
Why landmark (metrics): Cited ~110 times; catalyzed rapid adoption of spectral cytometry across IO programs and cores by providing a clear, implementable playbook.
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