CHICAGO, May 30 /PRNewswire/ -- Ipsogen SA (Marseilles, France and New Haven, CT, USA), a cancer profiler that markets molecular diagnostic assays for leukaemia announced today that it is entering the breast cancer diagnostic market with the European launch of MapQuant Dx(TM) Genomic Grade. MapQuant Dx(TM) Genomic Grade is the very first molecular diagnostic test to accurately measure tumor grade, a consensus indicator of tumor proliferation, risk of metastasis and response to chemotherapy.
Histological tumor grading is considered a decision factor in most national and international guidelines to breast cancer treatment. While it is generally recommended to treat high-grade “grade 3" breast carcinoma with chemotherapy because they are chemosensitive and will often recur otherwise. By contrast, most low-grade “grade 1" tumors should not be treated with chemotherapy because they have a good prognosis and are often chemo-insensitive.
A key clinical issue is how to treat the 50% of breast cancers tested today as uncertain/intermediate “grade 2" by current methods - based on the visual examination of tumor sections under the microscope.
MapQuant Dx(TM) Genomic Grade test directly measures the expression of the 97 genes that best characterize high-grade vs. low-grade tumors. It can resolve these “grade 2" tumors into either “grade 1" or “grade 3" tumors in 80 % of cases.
MapQuant Dx(TM) Genomic Grade test is especially useful when tumor grade information can be decisive for prescribing a chemotherapy. According to most guidelines, this is the case for hormone-sensitive (ER+) node-negative (N-) invasive breast carcinoma.
“In these patients, most grade 2 tumors are treated by chemotherapy and hormonotherapy. It is expected that MapQuant Dx(TM) Genomic Grade test downgrades 70% of grade 2 tumors to grade 1. This would represent about 50,000 spared chemotherapies in Europe and USA annually,” said Dr. Jean-Marc Le Doussal, Director of the Breast Cancer Program at Ipsogen.
“MapQuant Dx(TM) Genomic Grade demonstrates our commitment to address clinicians’ needs by translating the genomic profile of each tumor into reliable, intelligible and decisive information for pathologists, oncologists and patients,” said Vincent Fert, President and CEO of Ipsogen.
About MapQuant Dx(TM) Genomic Grade
Clinical Validation
MapQuant Dx(TM) Genomic Grade measures the Genomic Grade index, a gene expression index discovered by oncology researchers at the Bordet Institute (Brussels, Belgium) and ISREC (Lausanne, Switzerland), two leading European cancer research institutes. In their seminal paper published in 2006 in the Journal of the National Cancer Institute (1), Pr. Sotiriou & colleagues showed that the grade, as measured today and since 1890 by histological examination of breast tumor sections under a microscope, could not describe the proliferation ability of 30 to 60 % of tumors. By contrast, the Genomic Grade index could capture proliferation in most tumors and showed superior prognostic and classification value over conventional grading methods. These findings have been validated in more than 1,100 patients, including a second study published last year in the Journal of Clinical Oncology (2). In 2008, 3 studies from the MD Anderson Cancer Center (MDACC) validated that high Genomic Grade index was predictive for benefit from chemotherapy (3).
Affymetrix Technology
MapQuant Dx(TM) Genomic Grade is based on Affymetrix technology. “Affymetrix is partnering with the world’s leading diagnostic companies like Ipsogen to bring about new diagnostic tests that can provide more efficient and complete methods to better diagnose, classify and manage complex diseases like breast cancer,” said Kevin King, president of Affymetrix. “Affymetrix offers the only microarray instrumentation system that has been cleared for molecular diagnostic laboratories in the E.U. and U.S. and we continue to work with our partners to further enable the broad adoption of array-based diagnostic tests and help make personalized medicine a reality.”
Testing Solution
MapQuant Dx(TM) Genomic Grade is made available for diagnostic use in Europe by Ipsogen through its MapQuant Dx(TM) testing solution including: MapQuant Dx(TM) Path Kit, CE-marked, ensuring easy sampling, RNA-preservation and shipping at ambient temperature; ISO-17025 MapQuant Dx(TM) Lab Services performed by DNAVision SA (Gosselies, Belgium) using Affymetrix GeneChip® Systems 3000Dx2 (GCS3000Dx2) platform ensuring highly reproducible sample processing; and MapQuant Dx(TM) CE-compliant software, ensuring highly reliable quality controls, data processing and Genomic Grade index computation. MapQuant Dx(TM) testing solution is developed under the innovation support program of the French Health Products Safety Agency (Afssaps). Commercialization in the United States depends on FDA’s (Food and Drug Administration) formal approval.
About Ipsogen
Ipsogen is a cancer profiler that 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 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 has been inaccessible until now. Ipsogen is also a partner of choice for biopharmaceutical companies committed to revolutionary theranostics.
Strengthened by its first-rate scientific, clinical and technological partnerships, in addition to its highly-skilled multidisciplinary team in France and the US, 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 in general.
Ipsogen employed 40 people as of April 30,2008. Its headquarters are located in Marseille, France. The company also has a subsidiary, Ipsogen Inc., in New Haven, Connecticut, USA.
Find out more at http://www.ipsogen.com
References
(1) Sotiriou C et al. Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis. J Natl Cancer Inst. 2006 Feb 15;98(4):262-72.
(2) Loi S et al. Definition of clinically distinct molecular subtypes in estrogen receptor-positive breast carcinomas through genomic grade. J Clin Oncol. 2007 Apr 1;25(10):1239-46.
(3) Symmans WF et al. Use of genomic grade index (GGI) to predict pathologic response to preoperative chemotherapy in breast cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 541) - Tordai A et al. Evaluation of biological pathways involved in chemotherapy response in breast cancer. Breast Cancer Research 2008, 10:R37 - L. Pusztai et al. Combined use of genomic prognostic and treatment response predictors in breast cancer. J Clin Oncol 26: 2008 (May 20 suppl; abstr 527).
Source: Ipsogen SA
