The U.S. Food and Drug Administration (FDA) has given the green light to public health and other qualified laboratories to make emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of the new H1N1 strain. The panel is authorized for use in “individuals who have been diagnosed with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices.”

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June 2009 - Table of Contents

DTTR June 2009

H1N1 Outbreak Puts Focus on Lab Testing Capability

ACLU Suit Challenges Breast Cancer Gene Patents

Nanogen Files for Chapter 11, Agrees to Sell Assets

Myriad Sees MDx Revenues Rise 47%, Launches Seventh Test

Inside the Diagnostics Industry: FDA Clears CDC Test for H1N1, Companies Race to Develop Own Tests

CMS Proposal Would Limit Medicare Coverage for Warfarin Response Testing

Combination Test Can Predict End-Stage Renal Disease

JAMA Study Links Albumin Levels to Blood Clot Risk

Genetix Acquires SlidePath to Expand in Digital Pathology

Thermo Fisher to Acquire Alesco’s Biolab Division for $120 Million

Prometheus Partners With Rosetta Genomics on Molecular Tests for Cancer

‘Comparative Effectiveness’ Is New Buzzword in Washington

IVD Stocks Up 6%; Quidel Soars 43% on Swine Flu Outbreak

G-2 Insider: Personnel Changes at FDA