Ipsogen Accelerates its Development in Europe with the CE Marking of its JAK2 Diagnostic Kits
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’.
JAK2 Kits
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).
Since January, 2008, the World Health Organization (WHO) recognized 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.
Ipsogen’s blood cancer diagnostic tools
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 specialized 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).
About Ipsogen
Ipsogen, cancer profiler, develops and markets molecular diagnostic assays designed to map diseases and guide patients and clinicians’ decisions along the complex therapeutic path.
With more than 60 references already used routinely worldwide for the diagnosis, prognosis and follow-up of thousands of patients with leukemia, Ipsogen is now also targeting breast cancer. Its initial goal will be to provide diagnostic information that remained unavailable until now. Ipsogen is also a partner of choice for biopharmaceutical companies committed to the development of ’companion diagnostic‘ tests.
Strengthened by its first-rate scientific, clinical and technological partnerships, in addition to its highly-skilled multidisciplinary team in France and the USA, Ipsogen is striving to become the leader in the molecular profiling of cancers. It is pursuing its development and promotion of diagnostic standards that have a significant impact on patients, medical professionnals and society.
Ipsogen employed 40 people as of April 30, 2008. Its headquarters are located in Marseilles, France. The company also has a subsidiary, Ipsogen Inc., in New Haven, CT, USA.
To learn more visit : www.ipsogen.com
Contacts:
IPSOGEN
Marc Essodaigui, Marketing and sales Director
+ 33 (0)4 9129 3090 - essodaigui@ipsogen.com
ATCG PR
Corporate and product Communication
Marielle Bricman
+ 33 (0)4 9125 0785 - ipsogen@atcg-partners.com