CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by the lab industry press is the simple fact that, if the FDA were to […]
Lab Industry Unprepared For FDA Action on LDTs
Laboratory-developed tests (LDTs) performed daily in almost every clinical laboratory in the U.S.
- By Robert Michel
- > From the Volume XVII No. 14 - October 4, 2010 Issue
- Tags: any lab test, association of molecular pathology, cap, clia, clinical lab, clinical lab test, clinical lab testing, Clinical Laboratory, clinical labs, diagnostic assays, FDA Clearance, fda regulation of ldts, FDA regulations, genetic test, genetic testing, genetic tests, in vitro diagnostic, lab industry, lab test, lab testing, lab tests, laboratory accreditation, laboratory accreditation program, laboratory administrator, laboratory scientists, laboratory staff, laboratory test, laboratory testing, laboratory tests, labtest, labtests, ldt, molecular diagnostic, molecular pathology, pathologists, Pathology group, the clinical laboratory, the laboratory
