Cue Health has become the first company to obtain de novo authorization for FDA for COVID-19 home use tests. The regulatory milestone comes at a time when testing demand has waned resulting in layoffs in the space and when there are increasing reports of COVID-19 numbers in China.
The authorization also comes on the heels of WHO announcing COVID-19 is no longer a public health emergency of international concern, though it still poses a global threat.
The San Diego, CA-based company’s COVID-19 test won emergency use authorization in 2021.
With a demonstrated overall accuracy of 98%, the test detects all known COVID-19 variants of concern and integrates into Cue Care, the company's test-to-treatment service.
Ayub Khattak, Chairman and CEO of Cue Health, said, "We are honored to receive this landmark De Novo authorization from the FDA, which emphasizes the reliability and accuracy of our COVID-19 Molecular Test in home and point-of-care settings. Our integrated test-to-treatment platform, coupled with the recent authorization of our mpox test and several other molecular tests under FDA review or in clinical studies, helps enable faster and better-informed healthcare decisions while making care and treatment more convenient."
Many companies in the COVID-19 diagnostics space have been under tremendous strain since the demand for testing has declined. Cue, a company that raised $200 million in a 2021 IPO, reduced its workforce by 170 people. At the beginning of the year, Cue cut 388 positions, according to a report from MedTech Dive.
And most recently, Thermo Fisher Scientific announced it was closing down three of its facilities because of the decline in the demand for COVID-19 testing. The action resulted in the Waltham, MA-based company cutting 230 positions.