March 2007 Clinical Laboratory News: Volume 33, Number 3

 

COVER STORIES
The New Integrative Approach to Diagnostic Medicine
How Will the Acquisitions of Abbott, Bayer, DPC Impact Clinical Labs?
By Julie McDowell
  Corporate giants Siemens and GE are now positioned to establish themselves among the top in vitro diagnostic companies, with many observers saying that the move signals the beginning of a more comprehensive approach to diagnostic medicine.
 
Ready or Not, Here Comes Pharmacogenomics
Will FDA's Expected Change to the Warfarin Label Make Testing Mainstream?
By Deborah Levenson
  Laboratorian experts in pharmacogenomics and FDA officials agree: the forthcoming change to the warfarin label positions labs to take a leading role in educating clinicians about personalized medicine and to translate laboratory results into clinical practice.
   
FDA Weighs Reaction to Regulation of Multivariate Index Assays
Public Meeting Draws Large Crowd
By Julie McDowell
  FDA officials confronted both support and concern about the agency's draft guidance on a new class of tests known as in vitro diagnostic multivariate index assays. Some believe the guidance opens the door to FDA regulation of laboratory-developed tests.
   
SERIES ARTICLE
PSA Isoforms
The Next Generation of Prostate Cancer Detection
By Stacy Loeb, MD, and William J. Catalona, MD
  Although PSA testing has dramatically shifted the profile of newly diagnosed prostate cancer, its performance as a screening test has several limitations. The authors offer their view of the next generation of markers for prostate cancer. 
   
NEWSBRIEF
2006 Healthcare Report Reveals Low Screening Rates
 
PROFILES
News From the FDA
Diagnostic Profiles
Industry Profiles
Washington Profiles
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