Last month, the Food and Drug Administration (FDA) granted a landmark De Novo authorization for Cue Health’s (NASDAQ:HLTH) at-home COVID-19 test that delivers lab-quality results within 20 minutes. The move makes Cue Health the first company to receive De Novo authorization for an at-home molecular test for any respiratory disease. With a growing portfolio of at-home tests for a range of infectious diseases, the recent FDA authorization is the latest milestone for the San Diego-based healthcare technology company that is transforming the diagnostics space. Having already generated over $1 billion of revenue from its molecular COVID-19 test previously under FDA emergency use authorization (EUA) in 2021 and 2022 combined, the De Novo is a full authorization and allows Cue Health to continue to provide accurate testing at-home and at the point-of-care into the future. 

The global diagnostics market was valued at approximately $180 billion in 2022 and is projected to grow to over $348 billion by 2030. Some of the key drivers of that growth are molecular diagnostics and the at-home testing and point-of-care segments where Cue Health is focused. Molecular diagnostics analyzes DNA or RNA, and have traditionally been conducted in a lab, such as PCR testing. While antigen and lab-based PCR testing are both still common, convenient at-home and point-of-care molecular diagnostics have implications across the industry and are competing as alternative diagnostic solutions — playing an important role in infectious disease testing as they yield results that are both accurate and fast. 

During the pandemic, the use of telehealth and virtual care for diagnosis spiked to 69% of all doctor-patient visits. However, the broader need for and power of telehealth to improve outcomes and lives is still in high demand. Especially in diagnostics, the current system can often be inconvenient, inefficient, expensive, and disconnected. Cue is out to change that — the company reduces the duration of time between testing and receiving actionable health information from 1-14 days to under an hour. That seamless process eliminates much of the inefficiencies in the current standard approach to healthcare delivery.  

Cue Health is fixing this point of friction for both patients and providers. The company’s mission is to empower people to live their healthiest lives, and that starts with enabling access to health information and actions that are personalized and proactive anywhere and at any time. The healthcare technology company’s diagnostic solutions for use at-home and at the point-of-care deliver results in ~20 minutes with lab-quality accuracy. Its COVID-19 test that just received De Novo authorization demonstrated overall accuracy of 98%.

Cue’s platform has also become highly valuable for healthcare providers and the company has stated that “point-of-care is the largest near-term opportunity for Cue’s differentiated offering,” with strategic expansion into medical facilities and offices around the nation representing a massive market. Cue’s accurate, fast, and reliable results make the easy-to-use test a convenient, cost-effective option for diagnosing patients at the office. Instead of waiting to follow up with patients after lab results come in, healthcare providers can get lab-quality results in minutes and identify the best treatment options for that patient that very day. 

In addition to the COVID-19 test, Cue Health has received emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test for any CLIA-waived facility, and has submitted an EUA application for a flu-and-COVID-19 multiplex test, and De Novo requests for a standalone flu test and a respiratory syncytial virus (RSV) test. All of these would run on the same easy-to-use Cue Reader and feature seamless connectivity to the Cue Health App so that customers can go from diagnosis to treatment within the same day. 

The company’s overarching goal is to put people in greater control of their health. With this at the heart of what Cue does, it also added a suite of at-home screening and diagnostics kits in March that allow customers to mail samples for processing in a lab to complement its diagnostic testing strategy. The mail-in kits include panels for markers of heart, liver, or kidney health as well as colon cancer screening and comprehensive sexual health panels for men and women. The company continues to add tests and treatments to its pharmacy offering for other common health and wellness conditions, such as hair loss and erectile dysfunction, among others.