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Beckman Coulter Receives FDA Clearance for First IVD Test Delivering Flow Cytometric Leukemia & Lymphoma Analysis

Beckman Coulter Diagnostics

ClearLLab products improve laboratory workflow by reducing manual preparation and routine validation

13 Jul 2017
Abigail Berry
Administrator / Office Personnel

Product news

Beckman Coulter Life Sciences has welcomed the announcement from the Food and Drug Administration (FDA) that it had received regulatory clearance (via the De Novo Process) to market its ClearLLab reagents for in vitro diagnostic use in the US. This is a milestone for the company as it globally expands its portfolio of clinical flow cytometry systems.

The ClearLLab reagents deliver the first preformulated, IVD antibody cocktails for leukemia and lymphoma* immunophenotyping in the clinical lab. The FDA confirmed that the test ‘provides consistent results to aid in the diagnoses of these serious cancers’. The FDA evaluated data from a multi-site clinical study which compared panel results to alternative detection methods.

Beckman Coulter’s Miami operation is already globally recognized as a center of innovation for clinical flow systems’ development**. The company is now building on this expertise to develop a new and advanced range of clinical flow systems to be launched over the next five years. ClearLLab is the first of this new generation of IVD systems, which are being developed to specifically address the diagnostic challenges and differing global workflow requirements of clinical laboratories.

Dr Mario Koksch, Vice President and General Manager of Beckman Coulter’s Cytometry Business Unit said: "Flow cytometry is a powerful tool for the detailed and fast analysis of complex populations, with the technique becoming increasingly valuable to the clinical hematology laboratory.

“Clearance to market the first IVD L&L reagents in the US has opened the door to the expansion globally of our clinical reagent and instrument portfolio.”

ClearLLab delivers fast and accurate qualitative identification of various hematolymphoid cell populations by immunophenotyping on the FC500 flow cytometer. With the reliability of a standardized kit and protocols, the premixed combinations offer LEAN-focused benefits which:

  • Reduce manual error and validation time
  • Accelerate sample preparation time
  • Improve workflow
  • Streamline lab inventory management
  • Provide confidence in the accuracy and reliability of results.

As Dr Koksch added: “The routine use of ready - to - use ClearLLab reagents delivers greater efficiency and cost savings. Preformulated antibody combinations enable the lab to avoid the potential errors of manual antibody cocktail preparation, with the reassurance of standardized reporting to international guidelines.”

ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia1. They are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia. WHO, in collaboration with the European Association for Hematopathology and the Society for Hematopathology, recently made important changes to the classification of these diseases. These included new criteria for the recognition of some previously described neoplasms as well as clarification and refinement of the defining criteria for others.2

*For lymphoma this refers to Non-Hodgkin’s lymphoma only

** Beckman Coulter Life Sciences is a separate company from Beckman Coulter Diagnostics and produces clinical flow cytometry systems for both Danaher companies.

References

1 Davis BH, et al. 2006 Bethesda International Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia.

2 Vardiman JW, Arber DA, Brunning DR et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes.

Links

Beckman Coulter DiagnosticsCompany website

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Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.LeukemiaCancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Cancer ResearchAlthough cancer is often referred to as a single condition, it actually consists of more than 100 different diseases. Microscopy, mass spectrometry, high throughput sequencing and flow cytometry are some of the most common techniques employed in cancer research labs.

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