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.
\u2018FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas\u2019 with the FDA confirming that the test \u2018provides consistent results to aid in the diagnoses of these serious cancers\u2019. The FDA evaluated data from a multi-site clinical study which compared panel results to alternative detection methods.
Dr Mario Koksch, Vice President and General Manager of Beckman Coulter\u2019s Cytometry Business Unit said: \u201cFlow 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. \u201cClearance 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.\u201d
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 management and provide confidence in the accuracy and reliability of results.
As Dr Koksch added: \u201cThe 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.\u201d
ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia. 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.\nwww.beckman.com<\/link>\n","protected":false},"excerpt":{"rendered":"
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 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[35],"tags":[],"_links":{"self":[{"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/posts\/973"}],"collection":[{"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/comments?post=973"}],"version-history":[{"count":0,"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/posts\/973\/revisions"}],"wp:attachment":[{"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/media?parent=973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/categories?post=973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clinlabint.com\/wp-json\/wp\/v2\/tags?post=973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}