EGFR testing

NEW YORK (GenomeWeb) — Researchers from several European institutions working with AstraZeneca have published a study demonstrating that measuring EGFR mutations from circulating tumor DNA compares favorably to tissue-based EGFR mutation status.

Originally published May 7.

Boehringer Ingelheim has launched a campaign to educate healthcare providers about biomarker testing to personalize treatment for non-small cell lung cancer patients.

Using a pharmacogenetic strategy to home in on a molecularly defined non-small cell lung cancer patient population, researchers have shown in a clinical trial that the investigational EGFR inhibitor afatinib significantly prolongs survival in patients with EGFR-mutated tumors.

In separate agreements, Roche has obtained a worldwide sub-license from Genzyme to develop the EGFR assay, and will collaborate with OSI Pharmaceuticals to develop the companion diagnostic.

NICE's recommendation for NHS to pay for AstraZeneca's non-small cell lung cancer drug Iressa in EGFR mutation-positive patients marks the second personalized medicine product to be funded in the UK after Herceptin was approved in 2002 for HER2-overexpressing breast cancer patients.

In an out-of-court settlement, Qiagen and Roche decided they both would have distribution rights to TheraScreen tests from Qiagen subsidiary DxS.

Ahead of a cost-effectiveness appraisal by UK's NICE, AstraZeneca is paying for EGFR mutation testing for non-small cell lung cancer patients to determine if they will benefit from treatment with Iressa. The genetic testing program is part of a patient access scheme the company has agreed to with the National Health Service to provide more granularity about the cost and value of the treatment.

Clarient plans to commercialize Applied Genomics' five-antibody immunohistochemistry test for non-small cell lung cancer, called Pulmotype, within its network of pathologists by the first quarter of 2010.

According to an editorial in the New England Journal of Medicine, two new studies suggest "that EGFR mutations represent favorable prognostic markers of survival and are predictive of tumor shrinkage, but the evidence that they can predict a differential effect of tyrosine kinase inhibitors on survival is incomplete."

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