In response to a warning letter from the United States Food and Drug Administration (FDA), LabCorp (Burlington, N.C.) is no longer offering its OvaSure test for ovarian cancer. In a letter sent to LabCorp in late September, the FDA questioned the clinical validity of the laboratory developed test, which LabCorp launched in June.

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December 2008 - Table of Contents

DTTR December 2008 (full PDF issue)

Meridian Sees Double-Digit Growth in Diagnostics

Myriad Genetics Will Split Molecular Diagnostics, Pharma

Osmetech Begins Trials for Extended Warfarin Sensitivity Test

Invitrogen, Applied Biosystems Progress Toward Merger

Ikonisys Gets FDA Clearance for HER-2 Breast Cancer Test

ACLA Panel Sees Future of Genetic Testing in Multiplex, Microrray Analysis

LabCorp Discontinues OvaSure Testing After FDA Warning

Medicare Physician Fees Will Rise in 2009

Inside the Diagnostics Industry: As Rising Costs Threaten Future of Cancer Care, OncotypeDX Found to Influence Treatment Decisions

Sequenom’s Down Syndrome Test Enters Study

Protein-Based Blood Test Could Predict Impending Heart Attack

Risk of Esophageal Cancer Tied to Gene Variants

Study Finds Oral Fluid Drug Test Results Comparable to Urine Testing

Tumor Database to Combine Microscopy, Microarray Information

New CLIAC Guidance Will Tackle Molecular Testing

Paternity Testing Leader DNA Diagnostics Center Acquired by MTS Health Investors

LabCorp to Help Launch Reference Lab in Abu Dhabi

CMS Finalizes Anti-Markup Rules for Diagnostic Testing

IVD Stocks Fall 14%; Affymetrix Plummets 45%

A Blood Test to Predict Obesity?