Helix Receives FDA’s Emergency Use Authorization for its COVID-19 Test

San Mateo, Calif.-based Helix has been granted the FDA’s Emergency Use Authorization for its COVID-19 diagnostic, the Helix SARS-CoV-2 test.

The test is authorized for the qualitative detection of nucleic acid from the SARS-CoV-2 coronavirus in anterior nasal swab specimens.

The samples can be self-collected without supervision by adults age 18 and up who are suspected by their healthcare providers of having COVID-19 infections.

The kits may only be processed by two Helix laboratories in San Diego that are certified to perform the required high-complexity tests.