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PGx Labs Concerned by FDA’s Statements, Actions

Federal agency is telling genetic testing labs to assess if their PGx tests comply with regulations

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions …

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