Healthcare Industry News: genomic test
News Release - July 10, 2009
Ipsogen Reports Incorporation of the Genomic Grade in the 2009 St. Gallen International Consensus Meeting on the Primary Treatment of Early Breast CancerThe St Gallen Consensus Meeting Specifies that Genomic Grade Could be Considered as an Adjunct to Histological Grading
MARSEILLE, France, July 10 (Healthcare Sales & Marketing Network) -- 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.
MapQuant(TM) 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. MapQuant(TM) 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® 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).
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
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