June 2007 Clinical Laboratory News: Volume 33, Number 6


Senate Bills Call for Oversight of Laboratory-Developed Tests
Could New Requirements Overwhelm Labs and the FDA?
By Julie McDowell
  As Congress weighs two Senate bills calling for oversight of laboratory-developed tests over the coming months, those who have scrutinized the bills recommend that clinical laboratorians start preparing now for potential landmark changes to how diagnostic tests are regulated.
A New Era in Cervical Cancer Screening
What Changes Will New HPV Tests and Vaccines Bring?
By Deborah Levenson
  Forthcoming guidelines, new HPV DNA assays, and the HPV vaccine could lead to a new testing paradigm. But widespread HPV testing faces several hurdles, including validation concerns and clinician comfort with the Pap.
Aspirin Resistance
Ready for Routine Testing?
By Thomas S. Kickler, MD
  A variety of laboratory tests measure platelet function, and there has been much interest in applying them to assess the risk for future arterial thrombotic events in high-risk patients. Learn which lab tests measure the antiplatelet effect of aspirin and how labs should approach testing for aspirin resistance.
Voters Rate Lab Test Experience Favorably
A Challenge to Support the Future of Clinical Chemistry
News From the FDA
Diagnostic Profiles
Industry Profiles
Washington Profiles
New Products
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Next Month

Cancer Biomarker Guidelines, Standards Under Consideration

New POCT Connectivity Guidelines