Ipsogen Launches a New Test to Determine Tumor HER2 Status and Guide Herceptin(R) Prescription in Bre...(ate for as much as 20% of cases and this...),Health

Testing solution

Currently, tumors are tested for HER2 with 2 main complementary technologies: immunohistochemistry (IHC) which identifies HER2 protein expressed in the tumor cells and in situ hybridization (ISH), which quantifies 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 the expression of the HER2 protein at cell membrane level. The test, developed on a set of 152 tumors, was validated in 4 independent datasets totalling 269 tumors. The test correlates with the IHC method in 95% of the cases and it resolves IHC equivocal cases in 95 % of cases.

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

    - 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.

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

About IPSOGEN

Ipsogen, Cancer Profiler, develops and markets m
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