Ipsogen introduces new breast cancer genomic test

French molecular diagnostic company Ipsogen has launched the MapQuant Dx HR test in Europe. The MapQuant Dx testing solution has been developed under the Innovation Support Program of the French Health Products Safety Agency.

Running on an Affymetrix microarray diagnostic platform, this new genomic test will improve the identification of endocrine-responsive tumors by measuring the expression of genes related to oestrogen and progesterone biology in breast cancer, said Ipsogen.

The Genomic HR test measures the hormone receptor status of invasive breast tumors. It has been developed on a training set of 137 tumors with unequivoqual receptor expression by immunohistochemistry. It was validated in seven independent datasets totaling 691 tumors, the company said.

Together with the Genomic Grade test and the Genomic HER2 test, the Genomic HR test provides a complete genomic testing panel for breast cancer that will help pathologists to better determine tumor grade, HR and HER2 status, and, ultimately, allow a more individualized treatment decision in breast cancer patients, the company added.

The Genomic HR test is made available for diagnostic use in Europe through an ISO-17025/CLIA Lab Service performed by DNAVision (Gosselies, Belgium). It can also be performed directly by cancer care centers equipped with the CE-marked, FDA-cleared Affymetrix GeneChip 3000Dx2 (GCS3000Dx2) system.

According to Ipsogen, the MapQuant Dx testing solution for routine micro-array profiling of breast tumors also includes: a Path Kit, CE-marked, ensuring easy sampling, RNA-preservation and sample shipping at ambient temperature; and CE-compliant software, ensuring highly reliable quality controls, data processing and genomic test computation.