Pharmacogenetics product achieves CE mark for IVD
Jurilab, a privately-held Finnish biotechnology company, and Nanogen announce 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 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.
Pharmacogenetics is the study of genetic factors involved in causing individual variability in drug response.
According to a study published in the Journal of the American Medical Association, adverse drug reactions are a leading cause of hospitalization.
The US Food and Drug Administration (FDA) has recently released guidance encouraging the generation of more pharmacogenomics data and molecular diagnostic testing during drug development and clinical trials.
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 easy-to-use open-system sold both as a complete kit and a service.
Jurilab is dedicated to applying its proprietary discoveries of genes and genetic markers associated with the underlying cause of common diseases and drug response across healthcare.
The company's current product emphasis is on disease risk assessment and molecular subtyping tests, human-validated drug targets, pharmacogenetic profiling tests and biochemical and genotyping services.
Nanogen's advanced technologies provide researchers, clinicians and physicians worldwide with improved methods and tools to predict, diagnose, and ultimately help treat disease.
The company's products include real-time PCR reagents, the NanoChip electronic microarray platform and a line of rapid diagnostic tests.
Nanogen's ten years of pioneering research involving nanotechnology holds the promise of miniaturization and continues to be supported for its potential for diagnostic and biodefence applications.
Goal is to develop POC immunoassay that simultaneously detects influenza type A, type B, seasonal flu (H1N1 and H3N2) and avian flu (H5N1) in a simple to use assay format
Based in Italy, the Amplimedical diagnostics division has been active in the European and other markets since the early 1990s with its molecular diagnostic reagents
Nanogen, developer of advanced diagnostic products, announced that Fisher Scientific International has agreed to purchase approximately 5.7 million shares of Nanogen common stock at $2.65 per share
Cardiac Status line includes four FDA-cleared tests that can be used at the point-of-care to determine elevations of cardiac markers, diagnose acute coronary syndrome (ACS) as indicated by chest pain
Open and robust platform allows laboratories to use one system for multiple molecular applications, including the detection of SNPs and multi-gene targets for pharmacogenetics