In June, the United States Food & Drug Administration’s (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Device and Radiological Health, sent a letter to manufacturers who have listed analyte specific reagents (ASRs) with the FDA, reminding them to ensure that their Class II or Class III in vitro diagnostic devices that are currently inappropriately labeled and marketed as ASRs comply with the law by September 15 of this year.

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August 2008 - Table of Contents

DTTR August 2008 (full PDF issue)

California Cracks Down on DTC Genetic Testing

Monogram Launches Breast Cancer Assay

Invitrogen, Applied Biosystems to Combine in $6.7B Deal

BD’s C. difficile Molecular Test Gets CE Mark

J&J Acquires Swedish IVD Company

DTC Genetic Testing Under Greater Scrutiny

FDA Sends ASR ‘Reminder’ Letters to IVD Manufacturers

Dako Partners With Bristol-Myers Squibb for Companion Diagnostics

Rosetta Genomics Buys Parkway Clinical Labs for $3m+

New Biomarker-Based Test Predicts Prostate Cancer Recurrence

Elevated Fetuin-A Levels Associated With Increased Diabetes Risk

Urinary Albumin Levels Can Predict Hypertension

Boston Researchers Awarded Grant for Breast Cancer Biomarkers

CMS Adds More Waived Tests to Lab Fee Schedule

IVD Stocks Fall 9%; Third Wave Rises on Takeover News

See You at Lab Institute!