Progenika Receives CE Mark for First DNA Chip to Detect Mutations in Lipoprotein Lipase (LPL) Gene
BILBAO, Spain, September 27, 2010 /PRNewswire-FirstCall/ --
- LPLchip(R) Rapidly and Precisely Detects Mutations Causing LPL Deficiency, a Cause of Acute Pancreatitis
- LPLchip(R) Identifies Patients who Could Benefit From Gene Therapy, Such as AMT's Glybera(R), Currently Under Review for EU Approval
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 saliva 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.
The Progenika Group develops biochips in the field of personalised medicine aimed at the diagnosis, prognosis and prediction of response to treatment of complex illnesses in humans. The company offers molecular diagnostic tools in areas such as oncology, lipids, and nervous system disorders as well as the optimisation of their treatment.
Paramount among its technological developments are the LIPOchip(R) for the diagnosis of Familial Hypercholesterolaemia, and the BLOODchip(R) for ensuring compatibility in blood transfusions.
Founded in the year 2000, its research, development and production centres are located in the Biscay Technological Park and in Cambridge (Massachusetts, USA). It also has laboratories in the United Arab Emirates and in Kuwait. It has also set up commercial and intellectual property offices in Madrid and London.
At present, more than 150 scientists work in the company facilities and the company's products are sold in America, Europe and the Middle East.
SOURCE Amsterdam Molecular Therapeutics B.V