Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test.
The Cue COVID-19 Molecular Test detects genetic material from the SARS-CoV-2 virus. It consists of a nasal swab, or Cue Sample Wand, and a Cue Cartridge Reader. After taking the test, adults with respiratory infection symptoms receive the results in 20 minutes via the Cue Health App.
With the recent approval, Cue is the first company to receive FDA de novo authorization for an at-home COVID-19 test. In 2021, the diagnostics company was the first to receive emergency use authorization for its at-home, nonprescription molecular COVID-19 test.
Along with the de novo, the FDA established “special controls” that outlined the requirements for labeling and performance for similar COVID-19 tests and created a new regulatory classification, meaning similar COVID-19 tests may apply for FDA 510(k) clearance.
“This is an important milestone and we believe a good signal for Cue’s pipeline of respiratory molecular tests already submitted to the FDA, including for RSV, Flu + COVID, and Flu. In addition, in the sexual health category, we recently received FDA authorization of our mpox test and have our chlamydia and gonorrhea multiplex test in clinical studies. Improving the way healthcare is delivered with diagnostic-enabled care is at the heart of everything we do, and we look forward to building on this positive momentum,” Ayub Khattak, CEO of Cue Health, told MobiHealthNews in an email.
THE LARGER TREND
Cue went public in 2021 when it picked up $200 million in its initial public offering. At the time, the company detailed other diagnostics in the works that would eventually be compatible with its reader, including tests for flu, RSV (respiratory syncytial virus) and sexual health.
It has since offered test kits for heart health, sexual health, women’s health, metabolic health and wellness, including a food sensitivity panel, colon cancer screening and Vitamin D test.
The company was not immune to the layoffs in the digital health space this past year.
Last month, the company laid off 326 workers, about 30% of its workforce. The layoffs came just four months after the home diagnostics company let go of 388 employees, or about 26% of its workforce, as part of a larger cost-reduction plan.
Last summer, Cue laid off 170 manufacturing workers due to what the company said were larger economic challenges and the federal government’s move to divert funding from COVID-19 tests.