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Although this update is only for Plavix, the FDA is mulling whether to update the labeling for CYP2C19-inhibiting drugs, and is looking at whether drug response is compromised in all patients or only those with certain CYP2C19 mutations.

This week's labeling change follows an earlier update from the agency informing healthcare providers of studies indicating poor CYP2C19 metabolizers have limited response to Plavix.

Medco's study will examine whether the 70 to 75 percent of patients who are "extensive metabolizers" of Bristol-Myers Squibb's Plavix will have "comparable outcomes" to patients taking Eli Lilly's more expensive Effient.

Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.

"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.

The companies aim to offer the K-RAS mutation companion test to US markets.

Following the GWAS, researchers plan to conduct a prospective, randomized-controlled trial and form a pharmacogenomics consortium specifically focused on validating and discovering new gene-response variants for clopidogrel.

A team of scientists led by researchers at the University of Maryland Medical School reports today in JAMA that CYP2C19*2 influences Plavix treatment response as well as the frequency of coronary problems in those at higher risk of such events.

In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.

The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

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The US Food and Drug Administration has approved an RNA interference drug to treat acute hepatic porphyria.

Stephen Hahn, the nominee to lead the US Food and Drug Administration, underwent a Senate confirmation hearing yesterday, the Washington Post reports.

Gizmodo looks over the past decade of consumer DNA testing to find the field to be lacking.

In Nature this week: native RNA sequencing and analysis of a human poly(A) transcriptome, nanopore sequencing-based method to analyze short tandem repeat expansions, and more.