May 2010 Clinical Laboratory News: Volume 36, Number 5

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Blood Glucose Meters
Is FDA Ready to Tighten Up Accuracy Standards?
By Bill Malone

After a well attended March meeting on blood glucose meters, FDA now has support from stakeholders to work toward a two-track regulatory approach that would distinguish the needs of individuals monitoring diabetes at home versus healthcare professionals maintaining tight glycemic control (TGC) protocols in clinical settings.

A New Definition of Gestational Diabetes
Will Revised Diagnostic Criteria Help or Hurt?
By Genna Rollins

An international committee has released new recommendations on the diagnosis and classification of gestational diabetes. If healthcare providers accept these guidelines, two to three times more pregnant women could be considered to have the condition.


Array-based Cytogenetic Testing
Poised for a Transformative Role in the Lab and Clinical Genetics
By Bassem A. Bejjani, MD, and Marvin R. Natowicz, MD, PhD

DNA array-based testing has already contributed to advancements in clinical cytogenetics, especially assessment of DNA copy number changes.. As the technology becomes more accessible to labs, it will likely change the way in which cytogenetic abnormalities are diagnosed.


Warfarin Sensitivity Testing Cuts Hospitalization Rates


Regulatory Profiles

Industry Profiles

Diagnostic Profiles

News from the FDA

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Next Month

 What Can Labs Expect from Healthcare Reform?

Lab's Role in Detecting Misuse of Pain Medications.