HER2 testing

The three organizations are inviting comment from health professionals on the recommendations.

NEW YORK (GenomeWeb News) – Biomarker-based diagnostics company Nuclea Biotechnologies today announced a partnership with Wilex aimed at better managing the treatment of metastatic breast cancer.

NEW YORK (GenomeWeb News) – Dako today announced that the US Food and Drug Administration has approved its HER2 IQFISH pharmDx assay for marketing in the US.

By Turna Ray
Ventana Medical Systems has been in a deal-making frenzy around companion diagnostics development.

This article has been updated from a previous version to clarify information about ongoing efforts to resolve the discordant results of the two studies.
By Ben Butkus

Without speculating on a specific release date for the draft document, FDA's Elizabeth Mansfield said the companion diagnostics guidance is "definitely moving" through the agency.

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.

Hal Barron, Genentech's chief medical officer, said that "by using [Dako's] diagnostics to help identify the right patients" who will benefit from treatment, Genentech hopes to make Herceptin "the first targeted option for advanced HER2-positive stomach cancer."

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A new report highlights the potential threats posed by advances in synthetic biology, NPR reports.

A Bloomberg reporter tried to get her genetic data deleted, but found it's not so simple to do.

Johns Hopkins University's Steven Salzberg and his colleagues have come up with a new estimate for the number of human genes, Nature News reports.

In Genome Research this week: study of intra-tumor heterogeneity, workflow resources for EPIGEN-Brazil, and more.