Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use
The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.
- The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.
- Cue also requested De Novo classification from the FDA for the Cue RSV Molecular Test for at-home and point-of-care use.
- Cue also recently received De Novo authorization from the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test), which was the first De Novo granted for any home use respiratory test available without a prescription.
- The Cue molecular tests all run on the Cue Health Monitoring System (Reader), which has an installed base of more than a quarter million.