February 2014 Clinical Laboratory News: Volume 40, Number 2

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Guideline Gridlock
Will Clinicians Embrace or Ignore Sweeping New CVD-Related Recommendations?
By Genna Rollins

A prominent new guideline for assessing and managing cardiovascular disease risk recommends a shift away from the long-standing practice of titrating statin therapy to meet targeted cholesterol levels. This controversial new paradigm and its underlying risk calculator have divided clinicians and laboratorians, so how extensively it will be adopted remains to be seen.

A New Chapter in FDA Regulation
How Will the Final Research Use Only Guidance Affect Labs?
By Bill Malone

With a final guidance on how diagnostic companies can market research-use-only tests and instruments, FDA has drawn a line in the sand that could signal strict enforcement in the years ahead.


Viral Hepatitis
Overcoming Diagnostic Challenges
By D. Robert Dufour, MD, FCAP, FACB

Because chronic infection with hepatitis B (HBV) or hepatitis C (HCV) initially presents with minimal symptoms, many chronically infected individuals do not discover their illness until they develop cirrhosis or liver cancer. Laboratorians should familiarize themselves with the many tests available for HBV and HCV, which are essential for detecting viral hepatitis in time to prevent these complications.


Mortality Rates for Four Major Cancers in Decline


Regulatory Profiles
Industry Profiles
Diagnostic Profiles
News From the FDA

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An Updated Diagnostic Algorithm for Encephalitis

Big Data