CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprietary tests. Although that is true, any move to regulate LDTs also has the potential to cover […]
Many Questions About FDA Regulation of LDTs
Federal agency intends to look at patient risk as a primary factor in how it will regulate LDTs
- By Robert Michel
- > From the Volume XVII No. 14 - October 4, 2010 Issue
- Tags: acla, american clinical lab, american clinical laboratory, analyzer, analyzers, cap, clinical lab, clinical lab test, clinical lab testing, Clinical Laboratory, clinical testing, consumer lab testing, dark report, fda regulation of ldts, genetic test, genetic testing, genetic testing lab, genetic tests, impac, infectious disease testing, ivd manufacturer, lab administrator, lab industry, lab test, lab testing, lab testing companies, lab tests, laboratories, laboratory administrator, laboratory analyzers, laboratory association, laboratory industry, laboratory medicine, laboratory scientists, laboratory test, laboratory testing, laboratory tests, ldt, pathologists, Pathology group, pathology groups, personalized medicine, reference laboratories, specialty lab, testing laboratories, tests for cancer, the dark report, the laboratory
