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FDA’s final rule on LDTs: what does it mean for clinical laboratories?

FDA’s final rule on LDTs: what does it mean for clinical laboratories?

On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.

Unlock the benefits of nominal mass spectrometry for NPS analysis

Unlock the benefits of nominal mass spectrometry for NPS analysis

The development of analytical methods for the detection and quantitation of drugs and metabolites in a range of biological matrices is a challenging process. Forensic toxicology labs need a reproducible and reliable methodology to ensure the robustness of the data and the quality of the results. They also need robust and sensitive instrumentation that can detect drugs at trace levels with high specificity, especially when it comes to novel psychoactive substances (NPS), which can be difficult to monitor and control.

The costly consequences of unplanned downtime

The costly consequences of unplanned downtime

Unplanned downtime is a formidable adversary that businesses across various industries strive to minimize. Defined as the unexpected interruption of regular operations, unplanned downtime can wreak havoc on productivity, profitability and customer satisfaction. In this article, we delve into the causes of unplanned downtime, its far-reaching consequences and strategies to mitigate its impact.

Back to the new basics: Part 3 | LC vs. LC-MS and what it means for your lab

Back to the new basics: Part 3 | LC vs. LC-MS and what it means for your lab

In this final installment of our “Back to the new basics” series, we take one more look at analytical techniques and best practices in the lab, and opportunities to improve efficiency. Here, we explore the basic principles of high-performance liquid chromatography (LC) and liquid chromatography mass spectrometry (LC-MS), and how these techniques can affect a lab’s efficiency and productivity.

Back to the new basics: Part 2 | Do I need a single quadrupole or a triple quadrupole system?

Back to the new basics: Part 2 | Do I need a single quadrupole or a triple quadrupole system?

In this second installment of our 3-part “Back to the new basics” series, we continue to look at ways to improve lab productivity by using efficient techniques. The number of instrument options out there can be mind-boggling. Finding the right instrument—one that offers varying degrees of sensitivity, selectivity and specificity to meet your analytical needs—can be an intimidating challenge.

Back to the new basics: Part 3 | LC vs. LC-MS and what it means for your lab

Back to the new basics: Part 1 | Making the leap from GC-MS to LC-MS

Producing accurate results quickly in a demanding environment is no easy feat for analytical scientists. What’s more, many of us are constantly questioning ourselves—I certainly am—about whether we are employing the best technique for the analysis at hand.

It’s an overwhelming thought, considering the wide range of tools that are available to choose from, each of which offers varying levels of capacity, sensitivity, selectivity, specificity and cost. How do you meet the unique needs of your organization without breaking the bank? I get it, and I’m not here to convince you it’s easy. My aim is to guide you through the process to help you make the right decision for you.

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