Beckman Coulter Highlights the First US IVD Test Delivering Flow Cytometric Leukemia and Lymphoma Analysis in the Routine Clinical Lab

SAN DIEGO, CALIF. ─ (July 31, 2017) ─ Beckman Coulter Life Sciences featured its pioneering in vitro diagnostic ClearLLab reagents at the 69th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Laboratory Expo (CLE), which was held July 31 - August 3, 2017 in San Diego. Beckman Coulter Life Sciences, part of the Danaher Corporation, exhibited its expanding portfolio for the clinical lab on booth #3117 alongside Beckman Coulter Diagnostics (another Danaher company).**
ClearLLab reagents are the first to receive Food and Drug Administration (FDA) clearance (via the De Novo Process) to market them in the US. They deliver the first preformulated, IVD antibody cocktails for leukemia and lymphoma* immunophenotyping in the clinical lab. For clinical laboratories it means they no longer have to develop their own laboratory developed test (LDT), a technically demanding, manual, time-consuming, and potentially error-prone process. Previously, labs would have had to make and validate their own antibody cocktails. ClearLLab reagents simplify and standardize the process.
Beckman Coulter’s Miami operation is globally recognized as a center of innovation for the development of clinical flow systems**. 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. As easy to operate as a conventional hematology analyzer, they specifically address the diagnostic challenges and differing workflow requirements of clinical laboratories, worldwide.
‘FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas’ with the FDA confirming 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 alteative detection methods.
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 reagents deliver 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 preformulated combinations offer LEAN-focused benefits which:

• Reduce manual preparation and validation time
• Accelerate sample preparation time
• Improve workflow
• Streamline lab inventory managementProvide 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 inteational guidelines.”
ClearLLab reagents follow the 2006 Bethesda Inteational 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
The introduction of ClearLLab reagents further expands the portfolio of clinical diagnostic solutions offered by the diagnostic companies of Danaher Corporation, which include Beckman Coulter, Cepheid, Leica Biosystems, Radiometer, and SCIEX Diagnostics. The breadth of this portfolio extends from the established to novel diagnostic technologies for clinical and anatomic pathology laboratories and point-of-care testing. With a rich history and a tradition of innovation, the diagnostic companies of Danaher remain committed to developing new and unique diagnostic approaches for better, integrated patient care, and to helping the healthcare systems build comprehensive and efficient diagnostic services with a high degree of automation, standardization, and connectivity.

*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
Notes to Editor:
De Novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kind. ClearLLab reagents have been available in Europe under the CE-IVD mark since October 2015.
References:
1 Davis BH, et al. 2006 Bethesda Inteational Consensus Recommendations on the Immunophenotypic Analysis of Hematolymphoid Neoplasia by Flow Cytometry: Optimal Reagents and Reporting for the Flow Cytometric Diagnosis of Hematopoietic Neoplasia. Cytometry Part B (Clinical Cytometry 2007 72B: S5-S13
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. Blood 2009 114:937-951; doi: 10.1182/blood-2009-03-209262