Commercial Testing Service Available for Acute Myeloid Leukemia

The comprehensive molecular diagnostic testing service provides eight of the most powerful diagnostic markers to perform accurate AML molecular subtyping, necessary to stratify and optimize treatment for each patient.

The assay menu consists of the AMLprofiler (Skyline Diagnostics; Rotterdam, The Netherlands) and the Leukostrat fms-like tyrosine kinase receptor-3 (FLT3) and Nucleophosmin (NPM1) Mutation Testing (Laboratory for Personalized Molecular Medicine [LabPMM]; Martinsried, Germany). Samples of patient suspected of AML are collected by courier and shipped to LabPMM’s brand new testing facility in Germany. The results are reported back to the customer within five working days.

The AMLprofiler Assay is a microarray-based in vitro diagnostic (IVD) product for the detection of seven prognostic or diagnostic AML markers, including inv(16), t(15; 17), t(8;21), NPM1 insertion mutation A/B/D, CCAAT enhancer binding protein alpha (CEBPA) double mutation and clinically relevant high-ecotropic viral integration site 1 (EVI1) expression and low-brain and acute leukemia, cytoplasmic (BAALC) expression.

Henk Vietor, MD, PhD, the CEO of Skyline Diagnostics, said, "We have been commercializing the AML profiler as a diagnostic assay through our commercial network in Europe, which allows doctors to rely on accurate and fast testing of seven key markers in AML1. By launching this joint centralized testing service we can now also offer the qualities of our product to those laboratories and hospitals that do not wish to set up molecular testing themselves, with the same benefits: fast and reliable."

Jeffrey Edward Miller, PhD, CEO of LabPMM said, "We are excited about this collaboration since it represents the commercial launch of our Leukostrat FLT3 and NPM1 tests in Europe. While offering it as a testing service, it will be the only licensed and standardized, CE IVD registered testing available for FLT3 in Europe. It is our firm belief that a central standardized approach will facilitate the regulatory process and will have a very a real benefit for drug development, clinical trials, and, most importantly, patient outcome."

Related Links:
Skyline Diagnostics
Laboratory for Personalized Molecular Medicine