29.06.08 18:57 Age: 2 yrs
Ipsogen accelerates its development in Europe with the CE marking of its JAK2 diagnostic kits
Category: Leukemia, Investors
Ipsogen’s JAK2 V617F diagnostic kits are now available to all European diagnostic laboratories
Marseille, France, June 30, 2008 - IPSOGEN SA (Alternext - FR0010626028 - ALIPS), a molecular diagnostic company specialized in the development, the manufacturing and the commercialization of diagnostic assays for breast cancer and leukemia, today announces 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.
‘JAK2 tests represent a key range of products for Ipsogen; they already account for a major part of our sales’ says Vincent Fert, Ipsogen’s CEO, ‘with this CE marking, a much larger number of laboratories will now have the possibility to run this test’.
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