New product joins CE-marked chips for blood-donor compatibility and familial hypercholesterolemia.
Spanish gene-chip firm Progenika Biopharma obtained a CE mark for its LPLchip® DNA chip for detecting mutations in the lipoprotein lipase (LPL) gene. LPLchip is designed to diagnose patients with complete and partial lipoprotein lipase deficiency (LPLD), and it detects more than 120 mutations in the LPL gene. The EU approval is the first for a DNA chip for LPL mutations, the firm claims.
The product was developed as part of a 2009 agreement between Progenika and Amsterdam Molecular Therapeutics (AMT) to develop a companion diagnostic for use alongside the latter’s Glybera® gene therapy for LPLD. Glybera is currently under regulatory review in the EU, and is in Phase I/II development in the U.S. In August AMT said it was confident that Glybera was on track for a regulatory decision by the European authorities by mid-2011.
Progenika’s core business is the design and production of genotyping microarrays for the diagnosis and prognosis of genetically complex diseases and predicting patient response to therapy. Product development hinges on the firm’s Sendagene pharmacogenomics platform, which it claims allows the optimization of each stage of chip development.
The firm’s LIPOchip® array for the early detection of familial hyperchoesterolemia is designed to rapidly screen of over 250 mutations in the LDLR, APOB, and PCSK9 genes as well as detect copy number changes. Launched in Europe in 2004, LIPOchip was the first CE-marked DNA microarray for routine clinical diagnosis, Progenika claims. The firm’s BLOODchip® DNA-chip for blood donors screens for 128 polymorphisms representing the main allelic variants of the blood group factors: ABO, RhD, RhCE, Kell, Kidd, Duffy, MNS, Diego, Dombrock, and Colton, as well as 12 platelet antigens. The firm maintains that BLOODchip is the first extensive CE-marked blood-group gentoyping test to allow donor-recipient compatibility. PHARMAchip® is a tool for predicting drug response in a broad array of metabolism pathways. Evaluating 30 genes and 90 SNPs, the chip has been designed for both basic pharmacogenetics research and for use in clinical studies to help predict a patient’s risk of experiencing adverse drug reactions or failure to respond to particular treatments. Both BLOODchihp and PHARMAchip were launched in 2007.
In June Progenika granted Grifols exclusive worldwide distribution rights for its BLOODchip molecular biology products. At the start of this year ,the Spanish firm opened its new development center located in the Bizkaia Technology Park. Progenika has ploughed over €8 million into the new facility, which includes over 650 square meters of R&D laboratories.