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Pharmacogenetics Product Achieves CE Mark for IVD use
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Jurilab and Nanogen, Inc. have announced that the European CE Mark for IVD (in vitro diagnostic) use has been achieved for the DrugMEt® pharmacogenetic test.
"With this certification, Jurilab’s DrugMEt is now available for clinical diagnostic use within the European Union. This is a major step forward, both for healthcare in general and for Jurilab," said Kari Paukkeri, President and CEO of Jurilab.
"The pharmacogenetics market has been estimated to be growing at a compound annual rate of more than 20%, and CE designation of the Jurilab DrugMEt product strengthens our position in that market," said Howard C. Birndorf, chairman and CEO of Nanogen.
Nanogen holds worldwide, excluding Japan, distribution rights for DrugMEt, which is designed to detect up to 27 variations in eight genes encoding major drug-metabolizing enzymes.
First launched as a Research Use Only (RUO) product in 2004, the DrugMEt is designed to detect variation in genes including CYP2D6, CYP2C9, and CYP2C19, as well as duplication and deletion of the CYP2D6 gene.
Up to 48 samples can be processed simultaneously, using standard laboratory instruments and a range of different microarray scanners.
The medium-throughput capability is well-suited for genetically stratifying patient populations in clinical research trials. The DrugMEt test is an open-system sold both as a complete kit and a service.
