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Alere flu test wins first CLIA waiver for new nucleic acid assay

This article was originally published in Clinica

Executive Summary

Alere’s i Influenza A & B test has gained what FDA says is the first Clinical Laboratory Improvements Amendments (CLIA) waiver for a nucleic acid-based diagnostic. The approval marks an important milestone for moving molecular diagnostics into a greater variety of healthcare settings beyond sophisticated labs.

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