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EGFR Biomarkers

News and reporting on EGFR biomarkers.

Although the decision to withdraw its accelerated approval NDA doesn't preclude the company from filing an entirely new NDA for Iressa in NSCLC patients with EGFR mutations, as it has done in several European countries, AstraZeneca has decided not to try to relaunch Iressa with a PGx strategy in the US.

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.

In the study, out of three patients with ALK gene rearrangements, two responded partially to Infinity's investigational drug IPI-504, and one experienced prolonged stable disease while on the treatment for 7.2 months and had a 24 percent reduction in tumor size.

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.

In addition to several PGx studies presented at the conference, the International Association for the Study of Lung Cancer and the European Thoracic Oncology Platform's European EGFR Workshop Group proposed recommendations on EGFR mutation testing in NSCLC when patients are treated with AstraZeneca's Iressa.

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.

Scientists from Case Western Reserve University and Fluidigm have demonstrated how the nanofluidic digital PCR platform can detect and quantify EGFR mutations at the single-molecule level from lung tumors, including FFPE samples.

Clarient Insight Dx Pulmotype is a five-antibody immunohistochemistry test that the company said can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in NSCLC tumor specimens.

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.

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A survey by Nature finds that most researchers want scientific meetings to continue virtually or with a virtual component, even after the pandemic ends.

Bloomberg reports that the B.1.351 SARS-CoV-2 viral variant could prompt the formulation of better vaccines.

Certain blood proteins may be able to distinguish COVID-19 patients who will become critically ill from those who will not, the Atlanta Journal-Constitution reports.

In Genome Biology this week: algorithm to assess regulatory features, approach to integrate multiple single-cell RNA-seq datasets, and more.