Cue Health, a home diagnostics company, has announced that its at-home COVID-19 test, called the Cue COVID-19 Molecular Test, has received FDA de novo authorisation.
The Cue COVID-19 Molecular Test is designed to detect genetic material from the SARS-CoV-2 virus. It involves using a nasal swab known as the Cue Sample Wand and a Cue Cartridge Reader. Once the test is taken, adults experiencing respiratory infection symptoms can obtain their results within 20 minutes through the Cue Health App.
This recent authorisation marks a significant achievement for Cue, as it becomes the first company to receive FDA de novo authorisation for an at-home COVID-19 test. Previously, in 2021, the company obtained emergency use authorisation for its at-home, nonprescription molecular COVID-19 test.
In addition to granting de novo authorisation, the FDA has established "special controls" that define the labelling and performance requirements for similar COVID-19 tests. Furthermore, a new regulatory classification has been created, enabling similar COVID-19 tests to apply for FDA 510(k) clearance.
Cue Health CEO Ayub Khattak expressed enthusiasm about this milestone, considering it a positive sign for the company's pipeline of respiratory molecular tests already submitted to the FDA. These include tests for RSV, Flu + COVID, and Flu. Additionally, Cue has received FDA authorisation for its mpox test in the sexual health category and is conducting clinical studies on its chlamydia and gonorrhoea multiplex test. Khattak emphasised Cue's commitment to improving healthcare delivery through diagnostic-enabled care.
Cue Health became a publicly traded company in 2021 after raising $200 million in its initial public offering. During that time, the company disclosed plans for developing other diagnostics compatible with its reader. These include tests for flu, respiratory syncytial virus (RSV), and sexual health. Since then, Cue has expanded its offerings to include test kits for heart health, sexual health, women's health, metabolic health, and wellness. This range encompasses a food sensitivity panel, colon cancer screening, and Vitamin D test.
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