Company Profile

Skyline Diagnostics develops and markets microarray-based diagnostic tests using molecular signatures for personalized medicine in oncology. With its infrastructure, expertise and access to large collections of well-defined clinical samples, Skyline is an excellent partner for discovery, development and commercialization of new diagnostic assays and devices. Skyline is a privately owned company, boasting a highly experienced management team and professional life science investors.

Our core competencies are:

• Proven diagnostics track record – Track record in translational development of diagnostics.
• Biomedical science expertise – Team of scientists with biological, medical and diagnostic expertise. Specific knowledge of hematological and oncological indications.
• In-house bioinformatics and biostatistics capabilities
• Regulatory experience – Experience with regulatory processes in Europe (IVD CE-marking) and USA (FDA).
• Quality assured – QA and QC monitored product development process.
• Proprietary secure diagnostic data transfer framework – Secure IT infrastructure for diagnostic grade data transfer, analysis and reporting worldwide to facilitate immediate diagnostic analysis of microarray data.
• Affymetrix partner in diagnostics – Official Powered by Affymetrix Partner (Santa Clara, USA) and licensed the GeneChip® technology to develop diagnostic microarray products on the FDA approved Affymetrix GCS 3000Dx v.2 for applications in AML, ALL, MM and brain tumor diagnostics.
• Clinical trials – Track record in clinical trial organization and management.
• Diagnostic wet lab – Fully equipped diagnostic laboratory with Affymetrix GCS 3000Dx v.2 system.
• Direct communication – Agile and knowledgeable team with short communication lines.