Less than a year after approving a change in the labeling of warfarin to provide information about how people with certain genetic variations may respond to the popular blood thinner, the United States Food and Drug Administration (FDA) has cleared for marketing a third genotyping test to detect the presence of variations in the CYP2C9 and VKORC1 genes. Information about CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients at greater risk for warfarin sensitivity. The FDA previously cleared similar tests manufactured by Nanosphere (Northbrook, Ill.) and AutoGenomics (Carlsbad, Calif.).

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June 2008 - Table of Contents

DTTR June 2008 (full PDF issue)

SACGHS Report Calls for Expanded FDA Oversight

Myriad Genetics to Expand Direct-to-Consumer Marketing Efforts

FDA Clears Third Warfarin Genotyping Test

Congress Passes Ban on Genetic Discrimination, Measure Ready for Signing

Genzyme Genetics Launches Testing for Spinal Muscular Atrophy

Inverness Completes Acquisition of Matria Healthcare

SACGHS Calls for Expanded Regulation, Resources for Genetic Testing

Part B Lab Spending Climbs to $6.8 Billion in 2007

LabCorp Expands Companion Diagnostic Development Focus

Beckman Coulter Licenses HCV Test from Siemens

Group B Strep Increases Among Adults

NEJM Study Finds Genetic Links to Neuroblastoma

Saliva-Based Method Shows Promise for Early Diagnosis of Heart Attack

Enzo Biochem Buys Biomol to Boost Life Sciences Business

IVD Stocks Lose 4%; Affymetrix Drops 34%

Outreach Testing by the Numbers