As of June 15, 2012, a comprehensive molecular diagnostic testing service is available for any hospital in Europe. The assay menu consists of Skyline’s AMLprofilerTM, and LabPMM’s LeukostratTM FLT3 and NPM1 Mutation Testing. The standardized comprehensive assays provide 8 of the most powerful diagnostic markers to perform accurate AML molecular subtyping, necessary to stratify and optimize treatment for each patient.
Samples of patient suspected of AML are collected by courier and shipped to LabPMM’s brand new testing facility in Martinsried, Germany. The results are reported back to the customer within five working days.
Skyline Diagnostics’ CEO Henk Vietor: “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 7 key markers in AML1. By launching this joint centralized testing service we can now also offer the qualities of our product to those labs and hospitals that do not wish to set up molecular testing themselves, with the same benefits: fast and reliable.”
Says Jeffrey Miller, CEO of LabPMM GmbH: “We are excited about this collaboration since it represents the commercial launch of our LeukostratTM 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”
About Skyline Diagnostics BV
Skyline Diagnostics develops and markets array‐based diagnostic tests for personalized medicine. Skyline’s product the AMLprofiler simplifies AML diagnostics by replacing 7 separate assays by a single microarray‐based test. The company has built strong collaborations with leading scientists and pharmaceutical companies and has several strategic alliances with industrial partners for distribution and manufacturing.
About LabPMM GmbH
The Laboratory for Personalized Molecular Medicine is a CLIA- and CAP-accredited international reference laboratory focused on Personalized Molecular Medicine and Personalized Molecular Diagnostics. LabPMM provides comprehensive FLT3 mutation testing and provides the only access to a standardized, IP-protected test that consistently determines FLT3 mutation status. Our customer base includes cancer treatment and cancer diagnostic centers from around the world.
Contact Information
Skyline Diagnostics BV
Email vasb@fxlyvar-qvntabfgvpf.pbz
Website www.skyline-diagnostics.com
LabPMM GmbH
Email vasb@ynoczz.qr
Website www.labpmm.de
Reference
1 The AMLprofiler™ Assay is a microarray-based in vitro diagnostic (IVD) product for the detection of 7 prognostic or diagnostic AML marker, including inv(16), t(15;17), t(8;21), NPM1 insertion mutation A/B/D, CEBPA double mutation and clinically relevant high-EVI1 expression and low-BAALC expression.
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