Not waiting for the next annual update of the Medicare clinical lab fee schedule, the Centers for Medicare and Medicaid Services is adding 13 more waived tests to the schedule, effective July 1 with an implementation date of July 7. The tests are the latest approved by the Food and Drug Administration as waived under CLIA (the Clinical Laboratory Improvement Amendments).

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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!