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Today's Clinical Lab

'A New Era of Laboratory Testing'

The June 2024 Blood & Clinical Chemistry issue of Today's Clinical Lab is now available!

Published:Jun 11, 2024
|2 min read
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Though professional clinical laboratory bodies have pushed back against the FDA’s assertions of authority over laboratory-developed tests (LDTs) for decades, on April 29, the FDA announced a final rule establishing its jurisdiction over in vitro diagnostics, including LDTs.

As labs throughout the US begin to unpack the new rule and how it will impact current testing practices, many associations continue to oppose the new regulations, including the Association for Diagnostics & Laboratory Medicine (ADLM). In an exclusive Q&A, ADLM President Octavia M. Peck Palmer, PhD, FADLM, shares her thoughts on why LDTs should not be considered medical devices and what ADLM sees as the role of CLIA ‘88 in LDTs.

When it comes to implementing large-scale changes, project managers are often overlooked as a key resource. Our Business feature highlights the direct and indirect benefits of hiring project managers, as well as how to choose the right project manager for your laboratory.

Moreover, learn about how a novel genetic counseling program has improved test utilization management and enhanced clinical decision-making at University Health in San Antonio, Texas—and why other labs should get on board. We also speak with Megan Maxwell, MS, LCGC, about her career in the rapidly expanding discipline of genetic counseling.

In our Scientist Spotlight, we speak with microbiology specialist Luis Plaza, MLS(ASCP)CM, about championing the field of clinical microbiology and his podcast, Let’s Talk Micro. 

While tests for antinuclear antibodies (ANA) play a key role in the successful diagnosis of several systemic rheumatologic diseases, test performance is nuanced, requiring a strong working knowledge of other clinical features. Explore our Blood feature for a comprehensive guide to navigating the nuances of ANA testing. 

Similarly, in our Clinical Chemistry feature, Tyler Radke, MLS(ASCP)CM, highlights three strategies to improve hepatitis C testing and follow-up care, including single visit testing, universal screening, and simple EMR changes.

Finally, don’t miss our June 2024 Emerging Technologies Guide!

We hope you’ll join us virtually for our upcoming Infectious Disease & Antimicrobial Resistance Digital Forum. Register today for free and join us live on July 9.