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Proteomic Test Validation Insights by Alicia García is a document available to read on EtoBox.

What is Proteomic Test Validation Insights about?

This document discusses analytical validation of proteomic technologies for clinical use. It notes that while mass spectrometry is well-validated for research purposes, validating proteomic tests for clinical use presents unique challenges including sample pre-processing, the use of multiple technologies and algorithms, and a lack of reference standards. The FDA views the goals of analytical and clinical validation as no different for proteomic tests than other technologies, but acknowledges proteomic tests

Author

Alicia García

Language

EN