This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. […]
PGx Testing Labs Concerned by FDA’s Statements, Actions
Federal agency is telling PGx testing labs to assess if their PGx lab tests comply with regulations
- By Mary Van Doren
- > 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, dark intelligence, dark report, FDA Clearance, gene sequencing, genetic test, genetic testing, genetic testing labs, genetic tests, genomics, her2neu, her2neu test, lab industry, lab test, lab tests, laboratories, laboratory companies, laboratory industry, medical laboratories, molecular testing, pathologists, pgx labs, pgx testing labs, pharmacogenetic, pharmacogenetics, the clinical laboratory, the dark report
