FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing – Mobihealth News


The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home.

Developed by Cue Health, the Cue COVID-19 Test for Home and Over the Counter Use was first authorized for point-of-care use last June.

It uses a nasal swab sample collected from the lower nose to detect the presence of SARS-CoV-2 RNA, and transmits its results directly to the corresponding Cue Health App. The test includes a single-use Cue Sample Wand and a single-use Cue Test Cartridge – but also requires the Cue Cartridge Reader, a separate device that is reusable and battery operated.

The molecular nucleic acid amplification test generates and transfers its results to the app within «about 20 minutes,» according to the agency. Of note, consumers using the system will need to first create an account. Further down the line, the agency said that the app will eventually be able to report those results to public health authorities for wider-scale disease monitoring.

“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

“The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”


Molecular diagnostic tests are generally more accurate than their antigen or antibody counterparts, and Cue’s platform seems to be no exception. According to the FDA’s announcement, the newly-authorized test correctly identified 96% of positive samples from those who were known to have symptoms, as well as 100% of positive samples from those without symptoms.

The authorization of an OTC platform has the potential to increase the general public’s access to COVID-19 testing. And whereas long testing times can lead to individuals continuing to travel throughout their community until they receive a positive result, the Cue platform’s quick turnaround will encourage prompt quarantining and reduce exposure.

But also worth noting will be the supply of these tests. Last fall, Cue Health’s manufacturing facilities got a major shot in the arm thanks to a $481 million award from HHS and the Department of Defense.

Cue Health said at the time that it is targeting a production capacity of 100,000 tests per day – a benchmark that the FDA said the company now believes it will surpass by this summer.


Over the course of the past year, FDA said that it has authorized more than 330 COVID-19 tests and collection kits. While this process got off to a bit of a rocky start back in March 2020, the time since has found broad variety of mail-order, in-home, OTC or app-connected diagnostics trickle their way into public use.

Among the more noteworthy of these include LabCorp’s RT-PCR home sample collection kit (authorized in April, with a July update for asymptomatic and pooled testing); Lucira’s prescription at-home molecular test platform (authorized in November); Ellume Health’s app-connected OTC antigen test (authorized in December).

With these and numerous other options, a substantial number of consumer health testing and telehealth startups have added varying forms of mail-order COVID-19 testing services over the past several months.

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