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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.

Nanosphere is seeking FDA clearance for the assay, which would be used to provide early diagnosis of myocardial infarction and risk stratification for acute coronary syndromes.

Two FDA officials last week highlighted the agency's ongoing efforts to personalize healthcare by improving internal expertise in pharmacogenetics, increasing its focus on regulatory science, and launching a new group to coordinate its drug and diagnostics divisions’ application reviews for Rx/Dx combination products.

According to Woodcock, comparative effectiveness research and personalized medicine can come together in conducting community-based research. But for that, the US research infrastructure needs to be improved.

Speaking at a conference hosted by the Personalized Medicine Coalition, Clancy emphasized that AHRQ is in the business of conducting research, not setting healthcare policy. As such, the agency will continue to investigate personalized medicine interventions to inform the work of the CDC and EGAPP.

The guidance document is intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus, and provides information regarding filing for Emergency Use Authorization.

The FDA cleared the firm's microarray-based multiplex platform and a rheumatoid arthritis test that runs on the system.

Gen-Probe got the EUA for a test made by Prodesse for detecting H1N1.

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.

At a SACGHS meeting last week, FORCE said that Myriad Genetics sales representatives discourage doctors from referring patients to genetic counselors, and recommended the committee make recommendations for greater monitoring of such actions. SACGHS plans to invite Myriad to respond to the allegations.

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President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.