Cue Health has received FDA de novo authorization for its at-home COVID-19 test, becoming the first company to achieve this milestone. The test, called Cue COVID-19 Molecular Test, can detect genetic material from the SARS-CoV-2 virus, providing results in 20 minutes via the Cue Health App. The FDA has also established guidelines for labeling and performance of similar COVID-19 tests. Cue Health plans to expand its respiratory and sexual health tests, while also dealing with recent layoffs amid the company’s growth and challenges in the digital health sector.
Cue Health, a home diagnostics company, has announced that it has received FDA de novo authorization for its at-home COVID-19 test called the Cue COVID-19 Molecular Test. This test is capable of detecting genetic material from the SARS-CoV-2 virus. It comprises a nasal swab, known as the Cue Sample Wand, and a Cue Cartridge Reader. Once the test is taken, adults experiencing symptoms of respiratory infection can receive their results within 20 minutes through the Cue Health App.
This recent authorization makes Cue the first company to receive FDA de novo approval for an at-home COVID-19 test. Previously, in 2021, the company became the first to obtain emergency use authorization for its at-home, nonprescription molecular COVID-19 test.
In addition to granting the de novo authorization, the FDA has established “special controls” that specify the labeling and performance requirements for similar COVID-19 tests. It has also introduced a new regulatory classification, enabling similar COVID-19 tests to apply for FDA 510(k) clearance.
Ayub Khattak, CEO of Cue Health, expressed his enthusiasm for this achievement, stating, “This is an important milestone and we believe a good signal for Cue’s pipeline of respiratory molecular tests already submitted to the FDA, including for RSV, Flu + COVID, and Flu. In addition, in the sexual health category, we recently received FDA authorization of our mpox test and have our chlamydia and gonorrhea multiplex test in clinical studies. Improving the way healthcare is delivered with diagnostic-enabled care is at the heart of everything we do, and we look forward to building on this positive momentum,” as conveyed to MobiHealthNews via email.
Cue Health went public in 2021 after securing $200 million in its initial public offering. The company outlined its plans to develop other diagnostics that would be compatible with its reader, including tests for flu, respiratory syncytial virus (RSV), and sexual health.
Since then, Cue Health has expanded its offerings to include test kits for heart health, sexual health, women’s health, metabolic health and wellness. These include a food sensitivity panel, colon cancer screening, and Vitamin D test.
However, the company has faced challenges in the digital health sector, leading to layoffs. Just last month, Cue Health laid off 326 employees, which accounted for about 30% of its workforce. This reduction in staff followed a previous layoff of 388 employees (approximately 26% of the workforce) four months earlier as part of a larger cost-reduction plan.
Last summer, Cue Health had to lay off 170 manufacturing workers due to economic difficulties and the redirection of funding from COVID-19 tests by the federal government.
