Progenika receives CE Mark approval to market LPLchip in Europe

Sep 27 2010

Progenika Biopharma S.A., a pioneer in the field of personalized medicine, announced today that it has obtained the CE Mark allowing the sale in Europe of its LPLchip(R), the first DNA chip to detect mutations in the lipoprotein lipase (LPL) gene. This diagnostic tool rapidly diagnoses patients with complete and partial lipoprotein lipase deficiency (LPLD). The test has been developed under an agreement with Amsterdam Molecular Therapeutics Holding N.V. (Euronext: AMT), which has a gene therapy for patients with LPLD.

LPLD is characterised by a marked increase in triglycerides which can lead to serious complications such as acute recurring pancreatitis. Given the progressive nature of LPLD, early diagnosis is crucial to patients in order to reduce mortality and morbidity. The LPLchip(R) can precisely, quickly and economically detect more than 120 mutations in the LPL gene. The test uses Progenika's pioneering advanced DNAchip technology, which offers reliable and fast diagnosis. All that is required for analysis using the LPLchip(R) is a blood or salivaf sample.

At present, there is no approved treatment for LPLD, only lifestyle moderation guidelines to minimize diets rich in fat. However, AMT has developed a new genetic treatment for LPLD, Glybera(R), which has been filed for marketing authorization with the European Medicines Agency (EMA) in early 2010. A decision on the approval is expected mid-2011.

Long term follow-up of two clinical studies conducted in Europe and Canada is ongoing, as is a third clinical study in Canada. In these three studies, Glybera(R) has shown a sizeable decrease in the incidence of pancreatitis, or acute inflammation of the pancreas, the most debilitating complication of LPLD. In addition, these studies indicate that Glybera(R) has an excellent safety profile.