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CYP2C19 Linked to Plavix Response, Higher AE Risk

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Two new studies published in the New England Journal of Medicine found that patients with reduced-function alleles of CYP2C19 who had been treated with the popular anti-platelet drug clopidogrel experienced diminished platelet inhibition and a higher rate of major cardiovascular events compared to clopidogrel-treated patients without the alleles.

These studies are particularly meaningful since the US Food and Drug Administration has said it is looking to update labeling for Bristol-Myer's Squibb/Sanofi-Aventis' Plavix with genetic risk association information.

The first study, by Mega et al., found that patients with certain CYP2C19 alleles "had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events, including stent thrombosis, than did noncarriers."

Mega et al. was funded with research grants from Daiichi Sankyo and Eli Lilly, codevelopers of the anti-platelet prasugrel, which is currently under review at the FDA and stands to compete with Plavix. Plavix is BMS's top-selling drug. BMS did not respond prior to deadline.

The second study, by Simon et al., found that patients with an acute myocardial infarction who were receiving clopidogrel and were carrying CYP2C19 loss-of-function alleles had a "higher rate of subsequent cardiovascular events than those who were not." According to the paper, cardiovascular events were notably high among patients undergoing percutaneous coronary intervention.

Simon et al. was conducted by investigators from French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction, a registry affiliated with the French Society of Cardiology. The study was funded by unrestricted grants from Pfizer and Servier for FAST-MI, and a research grant from the French Caisse Nationale d'Assurance Maladie.

Turna Ray

PGx & Molecular Dx Notes

The Children's Hospital of Philadelphia received a $100,000 donation from the nonprofit Kortney Rose Foundation for research on childhood brain tumor research to be conducted at the hospital's Center for Applied Genomics.

Genomic Health reported findings from a -European study demonstrating that the Oncotype DX Recurrence Score result is an independent predictor of distant recurrence in both node-negative and node-positive hormone receptor-positive breast cancer patients who are treated with the aromatase inhibitor anastrozole or with tamoxifen.

The US FDA approved Roche's Cobas TaqScreen MPX Test for screening for the presence of different types of HIV in donated blood plasma and tissue.

DATAPOINT

£4.1million

Funding from the Wellcome Trust for a research partnership led by the Structural Genomics Consortium that will focus on developing chemical probes involved in
epigenetic signaling.

FUNDED GRANTS

$1,784,943/FY 2008
Development and Implementation of Genome-wide Exome Re-sequencing
Grantee: Stacey Gabriel, Broad Institute
Began: Sep. 30, 2008 ; Ends: Jun. 30, 2010

Gabriel will direct an effort using high-throughput sequencing to scan for DNA variants. "The aim of this proposal is [to] empower medical genetics by advancing DNA sequencing technology and analysis to a point at which one can routinely [sequence] all coding parts of the human genome in hundreds to thousands of samples for any given trait," the abstract says.

$342,738/FY 2008
A Novel Computational Framework for Individualized Clinical Decision-Making
Grantee: Nancy Guo, West Virginia University
Began: Sep. 15, 2008; Ends: Sep. 14, 2011

Guo and her team will study biomarker identification algorithms to determine the optimal combination of these tools to find clinically relevant biomarkers. As they describe in the abstract, "This proposal will develop a novel bioinformatics framework by combining genomics, proteomics, and clinical approaches for more informed clinical decision-making."

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