NEW YORK – Cue Health announced on Tuesday that it has made a de novo submission to the US Food and Drug Administration for a molecular diagnostic test to detect respiratory syncytial virus. The test is designed for at-home and point-of-care use.
The Cue RSV Molecular Test Cartridge uses a lower nasal swab and is compatible with the Cue Reader, which communicates test results of isothermal nucleic acid amplification digitally via Bluetooth to a mobile device in approximately 25 minutes.
Pending FDA clearance, Cue's RSV test would be the first at-home molecular diagnostic assay for RSV that has been fully reviewed by the FDA for safety and effectiveness, the firm said in a statement.
Serious sequelae of seasonal RSV infections occur in infants and the elderly, with the US Centers for Disease Control and Prevention estimating infection leads to 2.1 million outpatient hospital visits and 80,000 hospitalizations per year for children under 5 years of age. For adults age 65 and older, RSV leads to as many as 160,000 hospitalizations each year.
An RSV infection shares symptoms with influenza, COVID-19, and the common cold, but requires different management, Cue Health Chief Medical Officer David Tsay said in a statement. "This makes early detection of the virus even more important to lower the risk of a severe infection, especially among high-risk populations," he added.
Ayub Khattak, chairman and CEO of Cue Health, said the FDA submission brings the firm "one key step closer to providing a user-friendly, advanced molecular RSV test that has the potential to be a landmark new tool to manage the threat of RSV."
The FDA approved the first RSV vaccine for individuals 60 years of age and older earlier this month and three other RSV vaccines for older adults are in the final phases of testing, Cue noted. The FDA also granted fast track designation for an RSV treatment to accelerate its development and review this year.
Cue further noted that it has an installed base of more than 250,000 Cue Readers and continues to make progress to advance a wide range of future diagnostic tests and related services that are compatible with this system. Its COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription. It also received an Emergency Use Authorization from the FDA for its molecular mpox test and has submitted an EUA for its Cue Flu + COVID-19 Molecular Test. Its standalone molecular flu test is also under de novo review with the FDA for full clearance.