February 2008 Clinical Laboratory News: Volume 34, Number 2



Targeted Therapeutics in Non-Small Cell Lung Cancer
How Molecular Assays Guide Their Use
By Deborah Levenson


New guidelines on non-small cell lung cancer suggest testing for extra copies or mutations in the gene that encodes the epidermal growth factor receptor (EGFR), as well as mutations in the K-ras oncogene. Tyrosine kinase inhibitors may help patients whose tumors depend on activation of the gene that encodes EGFR, but oncologists and lab experts note that testing and treatment strategies are still evolving.

CMS Rolls Out New CLIA Policy Changes
What Labs Can Expect
By Phil Kibak


New CLIA policy changes—announced in August 2007 and instituted in January 2008—are minimal but have again stirred some controversy regarding equivalent quality control (EQC). CMS plans to retain EQC for the immediate future until the revised quality control policy using the CLSI consensus process is finalized.


Warfarin Pharmacogenetics

The Challenges of Laboratory Testing 
By Linnea M. Baudhuin, PhD


The label of the anticoagulant drug, Coumadin, now advises physicians to incorporate data on a patient’s genotype into dosing decisions, placing clinical labs at the forefront of personalized medicine. However, this field is not without significant challenges for the laboratory.

Mean Total Cholesterol Levels Fall
News From the FDA
Diagnostic Profiles
Industry Profiles
Regulatory Profiles
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