CLN Article

June 2013 Clinical Laboratory News: Volume 39, Number 6


Competency Assessment
Does the New CLIA Guidance Mean Big Changes?
By Bill Malone

The Centers for Medicare and Medicaid Services has always required labs to formally evaluate the competency of lab personnel in order to stay in compliance with CLIA law. Now the agency has rolled out new guidance on competency assessment requirements that every lab will want to follow closely in order to avoid sanctions.

The Next Generation of Prostate Cancer Diagnostics
Are Molecular Tests Ready?
By Genna Rollins

When and how to use the prostate-specific antigen test has been the subject of intense controversy, even as new ways to use PSA and new biomarkers have come to the fore that might improve how men and their doctors evaluate and act on PSA tests. Much of researchers' attention today is focused on using molecular biomarkers in place of or in conjunction with PSA.


Anti-Epileptic Drugs
Therapeutic Drug Monitoring of the Newer Generation Drugs
By Matthew D. Krasowski, MD, PhD

The newer generation antiepileptic drugs have greatly improved seizure control for patients, but labs have struggled with how to accurately monitor the plethora of drugs on the market. Many have wide therapeutic ranges, and the commercial immunoassays for measuring them have only recently become available.

Online ExtraOnline Extra
More on Newer AEDs
Chemical structures, pharmacokinetic parameters, and commercial assays.


Prediabetes on the Rise in the U.S.


2013 AACC Annual Meeting Preview
Thousands come to this must-attend event every year. Find out why!


Regulatory Profiles
Industry Profiles
Diagnostic Profiles
News From the FDA