Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen International...

Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen
International Consensus Meeting on the Primary Treatment of Early Breast
Cancer
The St Gallen Consensus Meeting Specifies that Genomic Grade Could be
Considered as an Adjunct to Histological Grading

MARSEILLE, France, July 10 /PRNewswire-FirstCall/ -- Ipsogen SA
(Alternext: ALIPS) today reported that the St. Gallen International Consensus
Panel on the Primary Therapy of Early Breast Cancer indicated for the first
time that the Genomic Grade could be considered as an adjunct to the
histological grade. These new guidelines, published online in Annals of
Oncology, represent the consensus opinion of 43 European and US experts on
early breast cancer treatment that emerged from the conference which took
place in March 2009.
According to the guidelines, histological grade 2 is considered as "not
useful for chemo-endocrine-therapy decision" as compared to the established
decision making value of histological grades 1 or 3. The panel also stated
that the dominant prognostic information is provided by proliferation.
MapQuantTM Genomic Grade is available to European oncologists and
pathologists. The genomic grade test analyzes a set of 97 genes to precisely
quantify the proliferation potential of the tumor, and has been validated in
several studies, covering more than 2 800 tumor samples. MapQuantTM Genomic
Grade contributes to high-quality phenotyping of breast cancer, by resolving
80% of histological grade 2 tumors in genomic grade 1 or 3 of similar long
term outcome as histological grades 1 and 3.
"The St Gallen Consensus Panel decision to identify the genomic grade as
a valuable adjunct in the pathological characterisation of breast cancer
legitimates Ipsogen strategy to provide pathologists and oncologists with
state of the art molecular tests generating critical information for
treatment decisions" said Helene Peyro-Saint-Paul, Chief Medical Officer,
Ipsogen. "These new recommendations are going to support our regulatory and
reimbursement efforts, a critical step to make our assay widely available to
patients and pathologists/physicians," added Vincent Fert, Chief Executive
Officer, Ipsogen.
"Treatment decision in a number of ER+ HER2- tumors remains a daily
challenge", said Dr Fabrice Andre, Institut Gustave Roussy, France. "With
these new St Gallen recommendations, pathologists and clinicians will be
encouraged to move one step forward and to progressively incorporate
molecular assays in their clinical practice in order to resolve these
equivocal cases and tailor their treatment strategy for each individual
patient."
About tumoral grade
Tumoral grade is a pivotal phenotypical feature of invasive breast
cancer, which contributes to long term patient prognosis. European and US
guidelines consider tumoral grade as one of the most important drivers in
treatment decision, and several carefully validated and widely used treatment
decision algorithms, such as the Nottingham Prognostic Index (NPI) or
Adjuvant On Line (AOL), use grade in their risk calculation.
Tumoral grade is currently assessed by histological methods such as the
Elston-Ellis score, which classifies tumors into 3 grade categories of
growing potential for proliferation. Grade 2, which represents a substantial
percentage of tumors (30-60%), has limited informative value for clinical
decision making.
About MapQuant(TM) Genomic Grade
The Genomic Grade test is made available for diagnostic use in Europe
through an ISO-17025/CLIA Lab Service. It will soon be available as a product
for cancer care centers equipped with a CE-marked, FDA-cleared Affymetrix
GeneChip(R) 3000Dx2 (GCS3000Dx2) system. The MapQuant(TM) Dx testing solution
for routine micro-array profiling of breast tumors also includes a Path Kit,
CE-marked, ensuring easy sampling, RNA-preservation and sample shipping at
room Temperature, and a CE-compliant software, ensuring highly reliable
quality controls, data processing and genomic test computation. MapQuant(TM)
Dx testing solution is developed under the Innovation Support Programme of
the French Health Products Safety Agency (AFSSAPS).
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 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. As for leukemia, Ipsogen's goal is to provide diagnostic information
that was not available 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 molecular
profiling of cancers. It continues its efforts to identify develop and
commercialise diagnostic tests that will become standard references and will
have a significant impact on patients, medical professionals and society.
Ipsogen employed 60 people as of June 30, 2009. Its headquarters are
located in Marseille, France. The company also has a subsidiary, Ipsogen
Inc., in New Haven, CT, USA.
For more information, visit: http://www.ipsogen.com
SOURCE Ipsogen SA

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