Cue Health's portable, fast COVID-19 test gains FDA emergency approval

Darrell Etherington

Fresh off a $100 million Series C funding round, molecular diagnostics startup Cue Health has more good news — it has received an Emergency Use Authorization (EUA) for its rapid, point-of-care COVID-19 test. The company got a $13 million grant from BARDA in March to help it scale its development and deployment of rapid diagnostics, and its COVID-19 test is obviously a key focus of that effort given the current pandemic.

Cue's test is portable and uses an RNA detection method to confirm the presence of the actual virus in a patient's system using nasal swab samples. The company says that it can provide results in as little as 25 minutes, and it's relatively simple to administer — both factors that make it potentially very useful in efforts to scale COVID-19 testing as the pandemic and its ensuing global health crisis continues.

The Cue Health test comes as a kit that includes the sample collection wand, along with a test cartridge. The cartridge connects to an app on a smartphone and transmits the diagnostic results to that device. Under the terms of the EUA granted by the FDA, the Cue test can be administered anywhere, so long as it's done under the supervision of a qualified healthcare professional. Cue says it's seeking additional authorizations from the FDA to expand use of the test to include allowing it to be done in settings including workplaces, schools and even in-home use.

To start, Cue Health's COVID-19 test will be rolling out in partnership with "leading healthcare institutions," according to the company, and then from there the plan is to expand it to a number of additional healthcare facility settings. Ultimately, Cue's goal is to create a range of molecular diagnostic testing solutions for not only COVID-19, but also influenza and other viruses, with the ability to flexibly deploy and conduct them in basically any setting where they're needed.

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