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March 2007 Clinical Laboratory News: Volume 33, Number 3
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| COVER STORIES |
The New Integrative Approach to Diagnostic Medicine
How Will the Acquisitions of Abbott, Bayer, DPC Impact Clinical Labs?
By Julie McDowell |
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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. |
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Ready or Not, Here Comes Pharmacogenomics
Will FDA's Expected Change to the Warfarin Label Make Testing Mainstream?
By Deborah Levenson |
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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. |
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FDA Weighs Reaction to Regulation of Multivariate Index Assays
Public Meeting Draws Large Crowd
By Julie McDowell |
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FDA officials confronted both support and concern about the agency's draft guidance on a new class of tests known as in vitro diagnostic multivariate index assays.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. |
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| SERIES ARTICLE |
PSA Isoforms
The Next Generation of Prostate Cancer Detection
By Stacy Loeb, MD, and William J. Catalona, MD
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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. |
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NEWSBRIEF |
| 2006 Healthcare Report Reveals Low Screening Rates |
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| PROFILES |
| News From the FDA |
| Diagnostic Profiles |
| Industry Profiles |
| Washington Profiles |
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