By Improving the Accuracy of Tumor Grading, MapQuant Dx(TM) Genomic Grade
Could Spare Tens of Thousands Chemotherapy Treatments per Year
ASCO Annual Meeting, May 30, 2008 - booth 23128
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(R) 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).
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Via: Healthcare
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