Ipsogen Announces the CE Marking of its “ProfileQuant(R) WT1″ Kit

By Prne, Gaea News Network
Sunday, March 15, 2009

MARSEILLE, France - WT1 is a Valuable Biomarker in the Prognosis and Follow-up
of Acute Myeloid Leukemia (AML) Patients.

- The ProfileQuant(R) WT1 kit was Developed and Validated in
the Context of an International Collaborative Study Coordinated by the
European Leukemia Network (ELN) Consortium.

- With its WT1 kit, Ipsogen Continues its CE Marking Strategy
and Confirms its Leadership Position in Molecular Diagnosis of Leukemia.

IPSOGEN SA (Alternext - FR0010626028 - ALIPS), a molecular
diagnostic company specialized in the development, manufacturing and
commercialization of diagnostic assays for breast cancer and leukemias, today
announces the CE marking of its ProfileQuant(R) WT1 kit.

The WT1 (for “Wilms’ tumor gene”) biomarker is used in the
prognosis and follow-up of normal karyotype AML patients, who account for
nearly half of AML adult patients. Quantification of WT1 expression level
helps predict disease aggressiveness and determine patient response to
treatment. In a recent large European study, WT1 proved to be a reliable
indicator that can be used for Minimal Residual Disease monitoring
distinguishing patients at differing risk of relapse.

The WT1 assay has been developed in the context of a collaborative project
coordinated by the ELN consortium, systematically evaluating 9 different
available assays to identify the best performing one.

“The WT1 gene has been reported to be switched on in the
majority of cases of AML making it an attractive target for novel treatment
approaches and monitoring response to therapy” says David Grimwade, leader of
the Minimal Residual Disease working group of ELN. “Therefore, there was a
pressing need to develop a highly reproducible and reliable assay that
quantifies WT1 transcript levels. IPSOGEN’s collaboration and industrial
support were key to the success of this international collaborative study
coordinated by ELN.”

The CE marking obtained by Ipsogen for the ProfileQuant(R)WT1
kit, confirms the quality of its validation and manufacturing processes. With
this kit, Ipsogen continues to contribute to the standardisation efforts in
place in Europe in order to reduce inter-laboratory variability and provide
consistent results over time.

“The CE marking of our ProfileQuant(R) WT1 will further
increase the adoption of this marker by European laboratories” says Vincent
Fert, founder and CEO of Ipsogen. “This test provides oncologists and
hematologists with a more precise picture of pathological processes and
disease evolution, and will help them to tailor their treatment strategy for
each individual AML patient, a critical need in a disease where only 60% of
normal karyotype AML patients survive on the long term”.

About IPSOGEN

Ipsogen, Cancer Profiler, develops and markets molecular
diagnostic tests designed to map diseases in order to guide patients and
oncologists decisions along their complex therapeutic path.

With more than 70 tests 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.

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 professionals and society.

Ipsogen employed 48 people as of December 31, 2008. Its
headquarters are located in Marseille, France. The company has also a
subsidiary, Ipsogen Inc., in New Haven, CT, USA.

For more information, visit: www.ipsogen.com

Source: Ipsogen SA

Contacts: IPSOGEN, Vincent Fert, President and CEO, Tel.: +33(0)4-9129-3090, fert at ipsogen.com; Hélène Peyro-Saint-Paul, Chief Medical Officer, Tel: +33(0)4-9129-3090, peyro-saint-paul at ipsogen.com; Stanislas Piot, Chief Financial Officer, Tel.: +33(0)4-9129-3090, piot at ipsogen.com; ATCG Press, Corporate and Product, Information, Marielle Bricman, Tel: +33(0)4-9125-0785, ipsogen at atcg-partners.com; NewCap, Financial Communication and Investor Relations, Axelle Vuillermet & Pierre Laurent, Tel: +33(0)1-4471-9493, ipsogen at newcap.fr

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