Cue Health was also previously the first company to receive an Emergency Use Authorization (EUA) from the FDA for an at-home molecular diagnostic test available without a prescription, which helped the company rake in over $1 billion in revenue over two years from both public (government entities) and private (point-of-care, enterprise, and direct-to-consumer) customers because it is highly accurate and has an easy-to-use design.

There are still an average of over 2,000 patients with COVID-19 admitted to hospitals every day in the United States. For both the flu and COVID-19, early diagnosis and treatment are critical to preventing serious illness and even death.

In March, the FDA recommended to manufacturers that had received EUAs for their COVID-19 tests to submit new applications and meet the requirements for full clearance in order to keep selling their products.

Cue has already achieved that new FDA authorization for its COVID-19 test., and it also has an EUA under FDA review for its Flu A/B + COVID-19 multiplex test, plus additional requests for De Novo classification under review including for its standalone flu test and its respiratory syncytial virus (RSV) test. The company already has an EUA for its molecular test to detect the monkeypox virus.

The at-home and point-of-care COVID-19 tests deliver lab-quality results to connected mobile smart devices in about 20 minutes. The test integrates into Cue Care, the company's state-of-the-art test-to-treatment service where patients can connect with a healthcare provider through the Cue Health App to discuss their results, form a treatment plan and have prescribed medications delivered straight to their door. 

COVID-19 Diagnostics Market Remains As The Disease Becomes Endemic

Cue Health’s diagnostic platform is able to help both patients and care providers stay ahead of COVID-19 over the long term, as the disease enters its endemic stage. By providing fast and accurate results, the platform could help minimize the spread of the disease and the risk of hospitalizations.

Cue’s Molecular Diagnostic Platform — A Game Changer For Testing

The test can be used on adults or children with or without signs or symptoms of COVID-19 and it is self-contained, meaning it doesn’t involve mixing fluids or running an involved testing procedure. Users simply insert the cartridge into their Cue Reader, collect a nasal sample with a Cue Sample Wand, and insert the Wand into the cartridge. About 20 minutes later, results are sent to the Cue Health App on the user’s phone.

With its head start in the transition from EUA to permanent market authorization for its at-home COVID-19 molecular test and a slate of additional at-home tests compatible with the same Cue Reader device, analysts have expressed optimism about the healthcare tech company’s future earnings potential.

This document may depict certain future planned care offerings which are subject to completion of development and/or may require regulatory authorization, clearance, or approval before they can be commercialized. 

Featured photo by Cue Health

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