Download Progenika obtains the CE Mark for the first DNAchip to detect

Progenika Receives CE Mark for First DNA Chip to Detect Mutations
in Lipoprotein Lipase (LPL) Gene
 LPLchip® rapidly and precisely detects mutations causing LPL deficiency, a
cause of acute pancreatitis
 LPLchip® identifies patients who could benefit from gene therapy, such as
AMT’s Glybera®, currently under review for EU approval
Bilbao, Spain 27 September 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®,
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® 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® 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®, 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® 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® has an excellent safety profile.
About Progenika
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® for the diagnosis of Familial
Hypercholesterolaemia, and the BLOODchip® 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.
www.progenika.com
Contact: Juan Buela, Director de Gestión, BRAINco Biopharma, S.L., E-mail: [email protected], Phone:
+34-94-406-4525