American Association for Clinical Chemistry
Better health through laboratory medicine
December 2013 Clinical Laboratory News: Volume 39, Number 12

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COVER STORIES

The Changing Landscape of Type 1 Diabetes
Is Population-Wide Autoantibody Screening on the Horizon?
By Genna Rollins

Emerging research about autoantibodies in type 1 diabetes is redefining the natural history of this disease, and could lead to new diagnostic criteria.

New Rules for Electronic Health Records
What Will Meaningful Use Mean for Labs in 2014?
By Bill Malone

In 2014, the federal government will ramp up the pressure on providers to embrace electronic health records with the second stage of meaningful use guidelines, requiring providers to meet tough new standards or face payment cuts.

SERIES ARTICLE

Flow Cytometry
New Considerations for Validating Laboratory-Developed Tests
By Virginia Litwin, PhD, Janelle Salkowitz-Bokal, PhD, MBA, and Pamela Steele, PhD

FDA regulation of laboratory-developed tests could limit the availability of flow cytometry assays, since they cannot be validated using standard methods. In light of this, international experts in the field of flow cytometry have published guidelines that address the differences between validating flow cytometric tests and traditional clinical chemistry assays.

NEWS BRIEF

ACA Expected to Help Revive Health Spending

INSIDE

ACP Advises Against CKD Screening; ASN Objects
At Odds: Lack of Direct Evidence of Benefits Versus Early Interventions to Slow Disease Progress
By Genna Rollins

The American College of Physicians recently recommended against regular screening for chronic kidney disease in asymptomatic adults without risk factors, but the American Society of Nephrology maintains that regular screening is vital to stemming the U.S. kidney disease epidemic.

ASCO/CAP Update HER2 Testing Guidelines
Algorithms Refined for Positive, Equivocal, Negative, and Indeterminate Results
By Genna Rollins

The American Society of Clinical Oncology and College of American Pathologists have updated their guideline on human epidermal growth factor receptor 2 testing in breast cancer. The new document includes recommendations for bright-field in-situ hybridization, as well as refined optimal testing algorithms and revised optimal test validation requirements.

Why Harmonization Matters
The Latest From AACC's Thought Leadership Series
By Bill Malone

In a free AACC webcast, AACC Past President Greg Miller, PhD, explains the current status of harmonization for clinical lab tests, as well as how leaders in laboratory medicine plan to tackle the formidable challenges of making different kinds of lab tests for the same analyte agree.

PROFILES

Regulatory Profiles
Industry Profiles
Diagnostic Profiles
News From the FDA

Interactive Digital Edition



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Next Month

Chronic Kidney Disease: The Search for Better Biomarkers

Preimplantation Genetic Diagnosis