Ipsogen, a cancer profiler that markets molecular diagnostic assays for leukemia and breast cancer, has announced the European launch of Mapquant DX Her2 test.
Developed on the Mapquant DX microarray diagnostic platform, Mapquant DX Her2 accurately measures a set of Her2-amplified genes that correlate with Her2 protein expression.
This Her2 test provides reliable, decisive information for pathologists, oncologists and patients.
The amplification of the Her2 region of chromosome 17 results in the constitutive over expression of the Her2 oncogene protein and fuels uncontrolled tumour growth in approximately 15 to 30 per cent of breast tumours.
Her2 is considered as a predictive marker for clinical benefit from trastuzumab, or Herceptin, a monoclonal antibody directed against the Her2 protein, in both primary and metastatic tumours.
However, current testing methods are inaccurate for as much as 20 per cent of cases and this may lead to missing the benefit of Herceptin therapy for some patients or, on the contrary, to prescribing unnecessary therapy for others.
Currently, tumours are tested for Her2 with two main complementary technologies: immunohistochemistry (IHC), which identifies Her2 protein expressed in the tumour cells, and in situ hybridisation (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 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 tumours, was validated in four independent datasets totalling 269 tumours.
The test correlates with the IHC method in 95 per cent of the cases and also resolves IHC equivocal cases 95 per cent of the time.
Mapquant DX Her2 test is available for diagnostic use in Europe together with Mapquant DX Genomic Grade test through Mapquant DX platform.
Secured sample collection and shipment at room temperature is done using the CE-marked Mapquant DX Path Kit.
Sample testing is performed using ISO-17025 Mapquant DX lab services at DNAVision on Affymetrix Genechip Systems 3000Dx2 (GCS3000Dx2), ensuring reproducible sample processing.
Data processing and result delivery with Mapquant DX CE-compliant software ensures reliable controls.
Mapquant DX is developed under the innovation support programme of the French Health Products Safety Agency (Afssaps).
Commercialisation in the US will depend upon the FDA's (Food and Drug Administration) formal approval.
