September 2010 Clinical Laboratory News: Volume 36, Number 9

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Regulation of Lab-Developed Tests
How Will FDA Expand Oversight?
By Bill Malone

Stakeholders packed the public meeting on laboratory-developed tests (LDT) held by the Food and Drug Administration in July to hear what the agency intends to do about regulating direct-to-consumer genetic tests and other proprietary tests.  What can labs expect as the agency now intends to forgo its policy of enforcement discretion and instead begin actively exercising oversight of LDTs.

Mass Spec in Clinical Labs
What Does It Take to Bring This Technology Online?
By Genna Rollins

Mass spectrometry primarily has been a research tool, but it is now edging towards routine use in clinical labs. Find out what experts say are the keys to successful adoption of the technology.


Celiac Disease
Navigating the Maze of Laboratory Testing
By Melissa Snyder, PhD, and Joseph A. Murray, MD

Celiac disease is a chronic inflammatory disease that affects the small intestine and can be controlled by eliminating gluten in one’s diet. But the biggest hurdle for treating celiac disease is identifying which test or tests to use to make the diagnosis.


CLS Programs Hold Steady despite Worker Shortages



Q&A with Bill Frist
Former Senate Majority Leader Dr. Bill Frist spoke at the AACC Partnership Presentation during the AACC Annual Meeting in Anaheim, Calif. in July. After his presentation, “A Heart to Serve, A Non-Partisan View of Solving the World’s Most Intractable Problems,” Frist offered his thoughts on the vital role clinical labs play in shaping medical care.


Regulatory Profiles

Industry Profiles

Diagnostic Profiles

News from the FDA

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Next Month

AACC Annual Meeting and Expo Highlights

The Future of Lab Medicine

The Next Generation of Lab Leaders