The U.S. Food and Drug Administration (FDA) has granted a CLIA waiver for the QuickVue respiratory syncytial virus (RSV) test manufactured by Quidel (San Diego, Calif.). The test qualitatively detects RSV, the leading cause of pneumonia and bronchiolitis among children two years of age and younger. The test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients.

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April 2008 - Table of Contents

DTTR April 2008 (full PDF issue)

JAMA Study Sends Chill Through IVD Market

Immucor Bets on Blood Genotyping

Third Wave Sees Clinical Revenue Grow 25% in '07

NEJM Study Probes Pharmacogenomics of Warfarin Metabolism

PerkinElmer Acquires Pediatrix’s Newborn Screening Lab

New Bioimaging System Promises Improved HER2 Testing

Ikonisys Boosts Automated FISH Platform with New Reference Lab

Quidel RSV Test Gets CLIA Waiver

Abbott to Co-Develop Pharmacogenomic Test for Lung Cancer Drug

Quest Diagnostics Signs Onto Google Health EHR

ACLA Presses SACGHS for Clarification on Genetic Testing Oversight

Beckman Coulter Launches High-Volume Testing System

IVD Stocks Fall 7%; Inverness Plummets 33%

Lung Cancer-Focused Allegro Diagnostics Raises $4 Million