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

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.