FDA Expands EUA for Rheonix’s COVID-19 MDx Assay

The FDA has expanded its Emergency Use Authorization (EUA) for Rheonix’s COVID-19 MDx Assay to include home collection of samples using the company’s home collect kit.

Initially authorized in April 2020, the assay can detect the SARS-CoV-2 virus in respiratory and saliva samples from individuals suspected of COVID-19 infections.

Under the expanded EUA, the samples can be self-collected at home by individuals age 18 years and older, self-collected under adult supervision by individuals 14 years and older, or collected with adult assistance for children five years and older.

Rheonix Laboratories said it plans to expand the use of the home collection kit through partnerships with other authorized laboratories.