Cue Health (Nasdaq:HLTH) announced today that it made a de novo submission to the FDA for clearance of its RSV molecular test.
The submission aims to garner full clearance of the test for at-home and point-of-care use. According to Cue Health, no respiratory syncytial virus (RSV) tests exist on the market for home use. Pending FDA clearance, the test could provide a first at-home molecular RSV test for use on people of all ages.
Cue’s RSV molecular test cartridge uses a lower nasal swab. It features compatibility with the Cue Reader, which communicates results digitally via Bluetooth. It can communicate these results in approximately 25 minutes.
“Both young children and older adults are at high risk for severe RSV infection, which includes symptoms similar to the flu, COVID-19, and the common cold, but has a distinct plan for managing care,” said Dr. David Tsay, chief medical officer for Cue Health. “This makes early detection of the virus even more important to lower the risk of a severe infection, especially among high-risk populations.”
Cue already has FDA emergency use authorization (EUA) for its molecular monkeypox test. It also applied for an EUA for its flu + COVID-19 test. The company’s standalone flu test remains under FDA review for de novo clearance, too.
According to Cue, it has more than a quarter of a million Cue Readers installed to date. The company added that it continues to make progress advancing its diagnostic offerings.
“With our submission to the FDA, we are 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, which is the leading cause of hospitalization of young children and a significant risk to the elderly,” said Ayub Khattak, Cue chair and CEO.