COVER STORIES

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.

SERIES ARTICLE

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.

NEWS BRIEF

INSIDE

PROFILES