1. U.S. Food and Drug Administration. In vitro companion diagnostic devices guidance. Issued August 6, 2014 [cited 2020 July 31]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-companion-diagnostic-devices.
2. U.S. Food and Drug Administration. Dako Hercept Test [cited 2020 July 31]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980018.
3. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). December 4, 2019 [cited 2020 December 16]. Available from: https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools.
4. U.S. Food and Drug Administration. Draft guidance: principles for codevelopment of an in vitro companion diagnostic device with a therapeutic product. Issued July 15, 2016 [cited 2020 July 31]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-codevelopment-vitro-companion-diagnostic-device-therapeutic-product.
5. U.S. Food and Drug Administration. Vysis ALK break apart FISH Probe Kit, Summary of Safety and Effectiveness. Issued August 26, 2011. [cited 2020 July 31]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p110012.