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Diagnostic Testing & Technology Report

H1N1 Outbreak Puts Focus on Lab Testing Capability
June 2009

The outbreak of a novel influenza A (H1N1) flu virus of swine origin that was first detected in April sent the world clamoring for effective diagnostics. The Centers for Disease Control and Prevention (CDC; Atlanta) promptly developed a polymerase chain reaction (PCR)-based diagnostic test kit to detect H1N1, secured FDA clearance for the test, and has now distributed test kits to all states in the United States, the District of Columbia, and Puerto Rico. The test kits are also being shipped internationally.

“We’re trying to build a strong foundation for understanding the spread of the virus by establishing lab diagnostic capability nationwide and throughout the world,” said Anne Schuchat, M.D., the CDC’s interim deputy director for science and public health program, in a May 12 call with reporters. “We’ve deployed the test kits to the states, and I’m happy to report that as of today, 29 of the states are now doing their own confirmatory testing for the novel H1N1 strain. We’ve sent the lab kits to a number of countries around the world, and testing is a critical part of understanding the situation around the world.” As of May 14, there were 4,298 confirmed and probable H1N1 cases in 47 states, including the District of Columbia.


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

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