Genetic Foresight securely and electronically delivers your reports to you and your physician. In delivering and storing the report we comply with all Health Insurance Portability and Accountability Act (HIPAA) regulations.
Currently the FDA has deemed companion diagnostic tests to be under the direct oversight of the Clinical Laboratory Improvement Amendments (CLIA). The lab work is performed within a CLIA certified lab, so all approval and certifications are completely met. The laboratory developed genetic test meets all of the quality, analysis of accuracy, precision, analytical sensitivity and specificity requirements under the CLIA validation of laboratory developed tests (LDTs). It is therefore an approved and registered LDT.
Genetic Foresight’s report leverages information selected from multiple sources such as the Clinical Pharmacogenomics Implementation Consortium (CPIC), the Federal Drug Administration (FDA), the European Medicines Agency (EMA), and other scientific organizations as well as clinically accepted genetic databases.