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Diagene Acquires Marketing Rights to Genetic Test

By Labmedica staff writers
Posted on 06 Dec 2006
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PGxHealth, a division of Clinical Data, Inc. (Newton, MA; USA), has entered into an agreement with Diagene GmbH (Reinach, Switzerland), whereby Diagene will have exclusive rights to market and sell Clinical Data's Familion test in Germany, Switzerland, and Austria.

Diagene is a reference laboratory for molecular genetics and medical analysis in Europe. Familion is a new genetic test designed to identify mutations in people with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome.

Cardiac channelopathies are a group of heterogeneous disorders that affect the ion channels of the heart. These disorders cause cardiac arrhythmias in otherwise healthy and typically young individuals and can lead to syncope, cardiac arrest, and sudden death. The ion channels mediate the flow of potassium, sodium, and calcium across the myocytes. Inherited channelopathies can be due to mutations in either sodium or potassium ion channel genes and are characterized by prolonged ventricular repolarization and risk for polymorphic ventricular tachycardia-ventricular fibrillation.

There is also evidence that mutations in these same genes may cause a percentage of the cases of familial atrial fibrillation, short QT syndrome, idiopathic ventricular fibrillation, progressive cardiac conduction disease, congenital sick sinus syndrome, and sudden infant death syndrome (SIDS).

The Familion test provides analysis of five major cardiac ion channel genes. This analysis includes sequence determination and variant detection (i.e., mutations and polymorphisms) in open reading frames (ORF) and intronic sequences containing splice junction sites. Sequencing is performed in both forward and reverse directions using dye-terminator chemistries.

Dr. Andre R. Miserez, founder and CEO of Diagene, said, "We are pleased to enter into this agreement with Clinical Data to exclusively provide their cardiac channelopathy test to customers in three significant markets in Europe. This agreement adds further depth and breadth to our existing portfolio of pharmacogenetic services and tests, and we see significant opportunities to build the franchise in Germany, Switzerland and Austria. Diagene has a strong relationship with many of the key research institutions and hospital systems in these countries. We look forward to exploring more opportunities with Clinical Data as it launches additional pharmacogenetic tests in Europe.”



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