Ipsogen Accelerates Its Development in Europe with the CE marking of its JAK2 Diagnostic Kits
News Jul 01, 2008
IPSOGEN SA has announced the CE marking of its JAK2 tests for myeloproliferative disorders.
The CE marking is a major requirement for the European Community regulation and the 98/79/CE directives for in vitro diagnostics medical devices.
These kits that were designed for Research Use Only (RUO) have now reached a regulatory status enabling a wider diagnostic use. JAK2 testing has revolutionized the diagnosis of this group of diseases that affect more than 40,000 Europeans every year.
Ipsogen is the exclusive worldwide licensee of the intellectual property on JAK2V617F mutation discovered by the INSERM team of Dr. Vainchenker at Institut Gustave Roussy, Paris, France.
This mutation plays a key role in the development of myeloproliferative disorders including Polycythemia Vera (PV), Idiopathic Myelofibrosis (IMF) and Essential Thrombocythemia (ET).
Ipsogen has developed a comprehensive range of tests enabling the indentification and the quantification of this mutation (JAK2 MutaScreen™ and JAK2 MutaQuant™ ranges, respectively).
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