HER2 testing | GenomeWeb

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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In PLOS this week: nasal microbial communities in asthma patients; sequencing-based way to detect, track schistosomiasis; and more.

The New York Times speaks with Vanderbilt's John Anthony Capra about Neanderthal genes in modern humans.

A draft guidance from the FDA suggests the agency wants to more tightly control gene-edited animals, according to Technology Review.

Researchers were among this weekend's protesters bemoaning the new US administration, Vox reports.