Decision Diagnostics Corp (DECN)

[HFM2]

FDA on At Home Tests:

As noted in the guidance, the policies outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not apply to at-home testing, including self-collection of a specimen at home. Any COVID-19 test for at-home testing, including self-collection of a specimen at home, with or without the use of telemedicine, requires an authorized EUA.

The FDA is supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy. This includes demonstrating the ability of a lay user to collect their specimen, run the test, and interpret their results accurately. We also consider the safety of the consumer, including safety from any exposure to toxic chemicals that may be used in the reaction. FDA encourages developers to discuss their validation of home use tests with us early in their development process.

COVID-19 tests for home use (including home collection of a specimen) are not eligible to be added to the umbrella EUA for laboratory developed tests (LDTs). Instead, FDA would authorize individual EUAs for such tests when the criteria for authorization are met and would include any necessary conditions of authorization to address different risks presented by specimen collection at home versus collection in a health care setting, as well as testing and interpreting results by a lay consumer rather than a professional.

FDA encourages developers to discuss their validation of tests intended for at-home testing, including use and/or self-collection of a specimen at home, with us early in their development process.

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2