The U.S. Food and Drug Administration (FDA) has cleared for marketing the AlloMap test developed by XDx (Brisbane, Calif.). The multi-gene, multi-pathway gene expression test can be used to assist physicians in managing heart transplant patients for potential organ rejection. AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.

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October 2008 - Table of Contents

DTTR October 2008 (full PDF issue)

Myriad Genetics May Spin Off Pharma Business

FDA Clears Third IVDMIA: XDx’s AlloMap

Nanogen to Merge With French Diagnostics Company

Meridian Bioscience Inks Canadian Distribution Deal

Inside the Diagnostics Industry: Nanogen’s David Ludvigson on Mergers, Markets, and Microarrays

New Gene Variant Linked to Prostate Cancer Risk

Protein Variant Predicts Chemotherapy Response

Pathwork Diagnostics Raises $20 Million

Pall Corporation Acquires GeneSystems

Physicians Frustrated by CMS’s Quality Reporting Initiative Feedback

IVD Stocks Down 6%; OraSure, Luminex Only Gainers

Biomarker for Soft Tissue Sarcoma