Cue Health said that it has submitted a De Novo application for its Cue RSV Molecular Test to the US Food and Drug Administration (FDA) to seek full clearance for its use at-home and point-of-care use.

According to the Nasdaq-listed healthcare technology company, there are no respiratory syncytial virus (RSV) tests available on the market as of now for home use.

Cue Health chairman and CEO Ayub Khattak said: “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 hospitalisation of young children and a significant risk to the elderly.”

The cartridge of the Cue RSV Molecular Test makes use of a lower nasal swab. It is compatible with the Cue Reader, which digitally communicates the results of the test through Bluetooth to a mobile device in nearly 25 minutes.

Subject to FDA clearance, the Cue RSV Molecular Test is expected to offer people of all ages an at-home molecular RSV test to use that has been reviewed fully by the regulator for safety and effectiveness.

Cue Health chief medical officer David Tsay said: “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.

“This makes early detection of the virus even more important to lower the risk of a severe infection, especially among high-risk populations.”

In March 2023, Cue Health was granted emergency use authorisation (EUA) for its molecular mpox (monkeypox) test from the FDA.

The health technology firm submitted an application in October 2022 to the FDA for a EUA for its Cue Flu + COVID-19 Molecular Test, while its standalone molecular Flu test is also under De Novo review with the US health regulator for full clearance.