December 2008 Clinical Laboratory News: Volume 34, Number 12

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A New Role for Hemoglobin A1c 
Should It Be Used to Screen for Diabetes?
By Gina Rollins


As the prevalence of pre-diabetes and diabetes rises, the desire is great to find ways to identify at-risk patients earlier in their disease process. Now, an independent panel has proposed using HbA1c as both a screening and diagnostic tool.

Proprietary Lab-Developed Tests
Responding to Innovation or Skirting Regulation?

By Bill Malone


Lab-developed tests allow companies a way to get novel tests onto the market as quickly as possible. However, FDA and other stakeholders remain cautious as more and more of these tests come online through the so-called “back door” into clinical practice.


Endocrine Testing
Improving Patient Care with Tandem Mass Spectrometry
By Ravinder Jit Singh, PhD


Although labs routinely use automated immunoassays for steroids, proteins, and peptides, FDA-cleared immunoassays are not available for all endocrine analytes that labs need to measure. LC-MS/MS can help labs fill the gap and can offer improved precision and accuracy over other methods.


NCQA Report: Reform Must Tackle Uneven Care


LabCorp Cuts OvaSure Test


Diagnostic Profiles

Regulatory Profiles

Industry Profiles

News from the FDA

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