House diagnostics firm Cue Well being introduced its acquired FDA de novo authorization for its at-home COVID-19 take a look at, dubbed the Cue COVID-19 Molecular Take a look at.
The Cue COVID-19 Molecular Take a look at detects genetic materials from the SARS-CoV-2 virus. It consists of a nasal swab, or Cue Pattern Wand, and a Cue Cartridge Reader. After taking the take a look at, adults with respiratory an infection signs obtain the ends in 20 minutes by way of the Cue Well being App.
With the current approval, Cue is the primary firm to obtain FDA de novo authorization for an at-home COVID-19 take a look at. In 2021, the diagnostics firm was the primary to obtain emergency use authorization for its at-home, nonprescription molecular COVID-19 take a look at.
Together with the de novo, the FDA established “particular controls” that outlined the necessities for labeling and efficiency for comparable COVID-19 exams and created a brand new regulatory classification, that means comparable COVID-19 exams could apply for FDA 510(ok) clearance.
“This is a vital milestone and we imagine a great sign for Cue’s pipeline of respiratory molecular exams already submitted to the FDA, together with for RSV, Flu + COVID, and Flu. As well as, within the sexual well being class, we lately acquired FDA authorization of our mpox take a look at and have our chlamydia and gonorrhea multiplex take a look at in medical research. Bettering the best way healthcare is delivered with diagnostic-enabled care is on the coronary heart of every little thing we do, and we look ahead to constructing on this optimistic momentum,” Ayub Khattak, CEO of Cue Well being, instructed MobiHealthNews in an e-mail.
THE LARGER TREND
Cue went public in 2021 when it picked up $200 million in its preliminary public providing. On the time, the corporate detailed different diagnostics within the works that may ultimately be suitable with its reader, together with exams for flu, RSV (respiratory syncytial virus) and sexual well being.
It has since supplied take a look at kits for coronary heart well being, sexual well being, girls’s well being, metabolic well being and wellness, together with a meals sensitivity panel, colon most cancers screening and Vitamin D take a look at.
The corporate was not resistant to the layoffs within the digital well being area this previous 12 months.
Final month, the corporate laid off 326 employees, about 30% of its workforce. The layoffs got here simply 4 months after the house diagnostics firm let go of 388 workers, or about 26% of its workforce, as half of a bigger cost-reduction plan.
Final summer time, Cue laid off 170 manufacturing employees because of what the corporate stated have been bigger financial challenges and the federal authorities’s transfer to divert funding from COVID-19 exams.