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 […]
PGx Labs Concerned by FDA’s Statements, Actions
Federal agency is telling genetic testing labs to assess if their PGx tests comply with regulations
- By Joseph Burns
- > From the Volume XXVI No. 12 - September 3, 2019 Issue
- Tags: clinical lab, clinical laboratories, Clinical Laboratory, clinical laboratory industry, companion diagnostic, companion diagnostic test, FDA Clearance, gene sequencing, genetic test, genetic testing, genetic testing labs, genetic tests, genomics, her2neu, her2neu test, lab industry, lab test, laboratories, laboratory companies, laboratory industry, medical laboratories, molecular testing, pathologists, pgx labs, pgx testing labs, pharmacogenetic, pharmacogenetics, the clinical laboratory
