NEW YORK — Cue Health said on Wednesday that it has received interim order authorization from Health Canada to sell its at-home molecular COVID-19 self-test in that country.
The isothermal nucleic acid amplification test consists of the single-use test cartridge and a wand for collecting lower nasal swab samples. It runs on the portable Cue Health Monitoring System, which was also authorized for sale in Canada, and displays test results on a connected mobile device in about 20 minutes via an app.
The test received Emergency Use Authorization from the US Food and Drug Administration in mid-2020 and CE marking in early 2021.
Cue Health said that it will begin offering the test in Canada for both professional and at-home consumer use without a prescription.
"Following the successful launch of our smart home lab platform in the US, we are pleased to now offer Canadian consumers access to our molecular COVID-19 self-test that combines accuracy, speed, and reliability," Cue Health Cofounder and CEO Ayub Khattak said in a statement.
Last month, the San Diego-based company inked a distribution deal for its COVID-19 test with Cardinal Health. It also just launched a subscription service for COVID-19 testing and virtual care.