FDA WATCH

FDA Watch: Agency Resounds the Alarm on Biotin Test Interference

In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The … [Read more...]

TESTING TRENDS

Testing Trends: The Debate Continues Over Regular Colorectal Screening for Average Risk Adults

Should adults age 50 to 75 who are at average risk and show no symptoms of colorectal cancer have regular colorectal screening exams? Last month, a major medical journal came out against regular … [Read more...]

EMERGING TESTS

Zika Antibody Detection Tests Go from Emergency to Commercial Clearance

 Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]

TEST UTILIZATION

Test Utilization: ‘Cascades of Care’ Cause Wasteful, Unnecessary and Anxiety-Producing Testing

Experts estimate that $200 billion is wasted annually on excessive testing and treatment. The typical dynamic is a chain reaction: Something “comes up” on diagnostic tests or screenings and triggers … [Read more...]

EMERGING TESTS

Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]

News

CMS Delays Controversial Hospital Price Transparency Rules

CMS has decided to delay its controversial proposal to require hospitals to post their standard prices based on their negotiated contracts with insurers. But while the delay represents a temporary … [Read more...]

Quest Shells Out $195K to Settle Massive HIV Data Breach Class Action  

Government fines, public embarrassment, loss of provider and patient trust. As if these consequences weren’t scary enough, massive PHI breaches can expose your lab to a new kind of risk: class action … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]

PAMA

PAMA Report: ACLA Tries for Decisive Blow in Federal Court Case

Now that its lawsuit challenging the PAMA pricing scheme is back in the lower federal court, the American Clinical Laboratory Association (ACLA) went back on the offensive by moving for summary … [Read more...]

CMS

ACLA Goes for Knockout Punch in PAMA Lawsuit

Case: Having survived a first-round setback, the American Clinical Laboratory Association (ACLA) went back on the offensive asking a federal court to strike down CMS’ scheme for implementing PAMA’s … [Read more...]


(-00000g2)