Validated technology

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Skyline Diagnostics has developed the AMLprofiler under QA, featuring a standardized procedure on FDA-cleared Affymetrix™ platform

Standardized and Validated Technologies

Skyline Diagnostics develops its products under a quality system according to ISO-13485:2003 and QSR 21 CRF part 820. Skyline Diagnostics laboratory operates in conformance with ISO-15189:2007. The AMLprofiler is analyzed on the FDA-cleared Affymetrix GeneChip 3000Dx v.2 System. In Europe, the AMLprofiler diagnostic service is CE-marked, with registration of the AMLprofiler kit in Europe and the USA expected soon.

Cost Effective

The integrated format of the AMLprofiler is a cost-saver for diagnostic laboratories by reducing labor and replacing numerous individual tests. In addition, improved classification reduces under- and overtreatment of the patient.

Best classification

Nine assays in one

Three days to diagnosis

Clear report

 

Dr. Molewaterplein 50, Suite Ee-1540, 3015 GE Rotterdam. The Netherlands, Europe. Phone: +31 (0)10 70 43 491. Fax: +31 (0)10 70 44 161. E-mail: bioinformatics@erasmusmc.nl