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The FDA’s Final Rule on LDTs: A New Era for Testing Labs

Issued in March, the FDA’s Final Rule on laboratory developed tests (LDTs) marks a departure from nearly 50 years of established regulatory standards. This means testing labs will soon face a dramatic shift in how they operate.  The Final Rule mandates new qu...

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The Ultimate Guide to Make Your Own QC in 5 Easy Steps

The process to produce the exact concentrations and analytes to suit your testing lab’s specific needs is costly, tedious, and time-consuming. But when nothing less than total control will do to eliminate uncertainty, there’s no substitute for generating the exa...

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