Ipsogen Launches a New Test to Determine Tumor HER2 Status and Guide Herceptin(R) Prescription in Breast Cancer

Tuesday, November 25, 2008 General News
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MARSEILLE, France, November 24 IPSOGEN SA(Marseille, France and New Haven, CT, USA), a cancer profiler that marketsmolecular diagnostic assays for leukemia and breast cancer announced todaythe European launch of MapQuant Dx(TM) HER2 test. Developped on the MapQuantDx(TM) microarray diagnostic platform, MapQuant Dx(TM) HER2 accuratelymeasures a set of HER2-amplified genes that correlate with HER2 proteinexpression. This new HER2 test provides reliable, intelligible and decisiveinformation for pathologists, oncologists and patients.

"MapQuant(TM) Dx HER2 is the second test to be developped on our MapQuantDx(TM) platform, after the Genomic Grade launched by Ipsogen earlier thisyear. Thanks to our experience in molecular diagnostics and to multipleresearch collaborations, we will keep delivering innovative tests at anaccelarated pace." says Dr. Jean-Marc Le Doussal, Director of the BreastCancer Program at Ipsogen.

Commenting on its experience with Ipsogen, Pr. Francois Bertucci, MedicalOncologist at Institut Paoli Calmettes Cancer Center in Marseille adds: "Iwas very pleased to collaborate with Ipsogen in rapidly and efficientlymoving from our research findings to a market-ready diagnostic test. As atranslational researcher, I believe that MapQuant Dx(TM) is a comprehensive"plug & play" solution, making research rapidly available to patients".

About MapQuant Dx(TM) HER2

Clinical Rationale

The amplification of the HER2-region of chromosome 17 results in theconstitutive overexpression of the HER2 oncogene protein and fuelsuncontroled tumor growth in approximately 15 to 30% of breast tumors. HER2 isconsidered today as a predictive marker for clinical benefit fromtrastuzumab, or Herceptin(R), a monoclonal antibody directed against the HER2protein, in both primary and metastatic tumors. However current testingmethods are inaccurate for as much as 20% of cases and this may lead tomissing the benefit of Herceptin(R)therapy for some patients or, on thecontrary, to prescribing unnecessary therapy for others.

Testing solution

Currently, tumors are tested for HER2 with 2 main complementarytechnologies: immunohistochemistry (IHC) which identifies HER2 proteinexpressed in the tumor cells and in situ hybridization (ISH), whichquantifies HER2 DNA copy number in the cell chromosomes. Some RT-PCR assays,that quantify the amount of HER2 mRNA, have also been developed more recently.

Ipsogen's MapQuant Dx(TM) HER2 test was designed to correlate with theexpression of the HER2 protein at cell membrane level. The test, developed ona set of 152 tumors, was validated in 4 independent datasets totalling 269tumors. The test correlates with the IHC method in 95% of the cases and itresolves IHC equivocal cases in 95 % of cases.

MapQuant Dx(TM) HER2 test is available for diagnostic use in Europetogether with MapQuant Dx(TM) Genomic Grade test through MapQuant Dx(TM)platform. It includes :

MapQuant Dx(TM) solution is developed under the innovation supportprogram of the French Health Products Safety Agency (Afssaps).Commercialization in the United States will depend upon FDA's (Food and DrugAdministration) formal approval.


Ipsogen, Cancer Profiler, develops and markets molecular diagnostic testsdesigned to map diseases in order to guide patients and oncologists decisionsalong their complex therapeutic path.

With more than 60 tests already used routinely worldwide for thediagnosis, prognosis and follow-up of thousands of patients with leukemia,Ipsogen is now also targeting breast cancer. Its initial goal will be toprovide diagnostic information that remained unavailable until now.

Strengthened by its first-rate scientific, clinical and technologicalpartnerships, in addition to its highly skilled multidisciplinary team inFrance and the USA, Ipsogen is striving to become the leader in the molecularprofiling of cancers. It is pursuing its development and promotion ofdiagnostic standards that have a significant impact on patients, medicalprofessionals and society.

Ipsogen employed 41 people as of September 30, 2008. Its headquarters arelocated in Marseille, France. The company has also a subsidiary, IpsogenInc., in New Haven, CT, USA.

For more information, visit: http://www.ipsogen.com- Easy and secured sample collection and shipment at room temperature using the CE-marked MapQuant Dx(TM) Path Kit. - Sample testing performed using ISO-17025 MapQuant Dx(TM) Lab Services at DNAVision SA (Gosselies, Belgium) on Affymetrix GeneChip(R) Systems 3000Dx2 (GCS3000Dx2), ensuring highly reproducible sample processing. - Data processing and result delivery with MapQuant Dx(TM) CE-compliant software , ensuring highly reliable quality controls.


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