RT-PCR

Originally published Feb. 20.

By Ben Butkus

This article has been updated to clarify that Genomic Health has submitted research data on Oncotype DX testing in the DCIS population to the San Antonio Breast Cancer Symposium. The abstract has not yet been accepted for presentation. Originally published Aug. 5.

In preliminary studies, "researchers observed a tumor size reduction of up to 76 percent over a treatment period of up to five months" in patients who had acquired resistance to standard tyrosine kinase inhibitors.

Two genomic tests for cancer risk recurrence -- Oncotype DX and PAM50 -- show reasonable agreement on high- and low-risk categories but do not agree in their classification of intermediate-risk patients, according to a recent comparison of the assays.

The company plans to take advantage of the double-digit growth rates it is seeing in the US market "to fund higher levels of investment in our international business, where market development activities are focused on physician education and payor reimbursement programs."

The drug/diagnostic codevelopment partners are each planning to complete regulatory submissions with the FDA in the first half of this year for a pharmacogenomic NSCLC treatment targeting patients with the EML4-ALK-fusion oncogene.

Genomic Health discussed the status of its ongoing work with Pfizer in renal cancer and suggested it might eventually develop a companion test for Erbitux that gauges mutations "beyond KRAS."

Affymetrix retains a majority share of the global array-based gene-expression market and believes its branched DNA-based QuantiGene kits, on board since its 2008 acquisition of Panomics, will spur future growth and provide it a platform to challenge RT-PCR.