The CE marking is a major requirement for the European Community regulation and the 98/79/CE directives for in vitro diagnostics medical devices
Ipsogen announces the CE marking of its JAK2 tests for myeloproliferative disorders.
These kits that were designed for research use only (RUO) have now reached a regulatory status enabling a wider diagnostic use.
Jak2 testing has revolutionised 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".
Ipsogen is the exclusive worldwide licensee of the intellectual property on JAK2V617F mutation discovered by the Inserm team of 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).
Since January, 2008, the World Health Organization (WHO) recognised the medical value of JAK2V617F mutation and recommended Jak2 testing as first intention for individuals for whom there is a suspicion of myeloproliferative disorders.
Jak2 tests offer a clear answer to unmet needs for the diagnosis of these group of leukemias, representing about 15% of blood cancers.
Pioneer in the field of leukemia molecular diagnostics, Ipsogen globally develops and markets a range of tests specific to most blood cancer molecular anomalies, including the rarest forms.
These tests, developed in close cooperation with highly specialised clinical centres, provide information on the type of disease (diagnosis, screening), the aggressiveness of cancer (prognosis), the efficacy of proposed targeted therapies (companion diagnosis) and the follow-up of minimal residual disease (monitoring).
