Cue Health Receives FDA Emergency Use Authorization for Its Rapid, Portable, Molecular Point-of-Care COVID-19 Test
San Diego, CA (June 12, 2020) - Cue Health Inc. (“Cue”), a healthcare technology company, announced today that it has received Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) for the company’s rapid, portable, point-of-care COVID-19 test. The Cue COVID-19 Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that causes COVID-19, in 25 minutes using a nasal swab sample taken from the lower part of the nose.
Cue’s COVID-19 test runs on the compact and portable Cue Health Monitoring System. A single-use COVID-19 test kit includes a Sample Wand and COVID-19 Test Cartridge. The system performs rapid molecular analysis at the point-of-care and transmits test results to the Cue Health App on a connected mobile device. The current FDA EUA allows the Cue COVID-19 test to be used anywhere under the supervision of qualified medical personnel. The company is intending to seek additional FDA authorizations for use of the COVID-19 test in settings such as the workplace, schools, and at home.
“We are very pleased to have received FDA EUA for our Cue Health COVID-19 Test. We believe our product can help provide greater access to rapid, distributed COVID-19 testing necessary for clinical decision making and to get our country back to work,” said Ayub Khattak, CEO of Cue.
Development and validation of the Cue Health COVID-19 test was supported by funding awarded by the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) at the U.S. Department of Health and Human Services. BARDA announced its collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test on March 31, 2020.
Cue plans to initially launch its COVID-19 test with select leading healthcare institutions and their satellite centers, followed by nationwide deployment across a variety of healthcare settings.
In addition to its COVID-19 test, Cue is developing additional test cartridges for use with the Cue Health Monitoring System, including tests for Influenza A/B. Cue envisions that in the coming years it will be able to leverage its advanced diagnostic testing platform to enable testing for a variety of infectious diseases in settings such as homes, schools, and businesses, in addition to clinical settings.