Progenika Receives CE Mark for First DNA Chip to Detect Mutations in Lipoprotein Lipase (LPL) Gene
– LPLchip(R) Rapidly and Precisely Detects Mutations Causing LPL
Deficiency, a Cause of Acute Pancreatitis
– LPLchip(R) Identifies Patients who Could Benefit From
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
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
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
At present, more than 150 scientists work in the company facilities and
the company’s products are sold in America,
SOURCE Amsterdam Molecular Therapeutics B.V