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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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3 Ways Custom QC Improves Precision in Your Test Results

For diagnostic laboratories, any test result is only as good as the quality control measures that validate your analytical processes. Accurate, trustworthy conclusions come down to control, and there’s no better way to control your testing requirements than creating a...

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