When COVID-19 hit in March 2020, testing for the coronavirus was an absolute disaster. From manufacturing mistakes to botched rollouts to bad communication, it was incredibly difficult to track down a reliable test.
Cue Health, an 11-year-old company based in San Diego, started working on a solution almost immediately and rolled out a COVID-19 testing system in June 2020. The at-home diagnostic system tests on the spot, eliminating the complicated logistics and problematic wait times of so many other testing protocols. The streamlined interface and ease of use made Cue’s Health Monitoring System the winner’s of the 2021 Innovation by Design Awards in the pandemic response category.
While Cue Health had been around for a decade before the pandemic, the COVID-19 diagnostic test was its first product. Prior to that, it focused purely on R&D; early research was on tests for things like pregnancy, fertility, and inflammation. In 2018, it shifted its focus to respiratory illnesses, particularly influenza, which meant it was well-positioned to pivot quickly to COVID-19 in March 2020.
The Cue system itself is straightforward: Users swab the lower part of their nose with a Cue swab (no need to stab it all the way up your nasal canal to get an accurate result). Then you put the swab into a single-use cartridge, and put that into the reader (which can be reused). After about 20 minutes, the results show up in corresponding the Cue app.
COVID-19 tests fall into two categories. Antigen tests—like Abbott’s BinaxNow, Quidel’s QuickVue, and Ellume—are cheap and deliver rapid results, but they only measure viral proteins in the virus. They’re less sensitive, which means they’re more likely to deliver false negatives when someone is contagious but hasn’t reached peak infection. Then there are molecular, or genetic, tests, which look for tiny amounts of RNA in the coronavirus. They’re highly sensitive and can detect genetic material before someone is symptomatic or has developed antibodies. The commonly used PCR tests are in the latter group and are considered the gold standard, but they generally have to go through a lab and typically require several days for results.
Cue’s tests are also molecular and test for RNA; studies that compared its results to those of lab PCR tests found that Cue’s test correctly identified 96% of samples in symptomatic people and 100% of samples in those who were asymptomatic.
The fact that Cue’s device can essentially provide the quality of a PCR test in the time frame of an antigen test makes it the best of both worlds. In March, the FDA granted Cue emergency use authorization for at-home and over-the-counter uses—it was the first over-the-counter molecular test to receive the EAU designation, although it’s not yet available for retail consumers.
Cue’s system already has a strong track record: It is being used by tech companies like Google (which offers Cue devices to all employees and interns), nursing homes, doctors’ offices, and correctional facilities—not to mention the Iditarod and the NBA Bubble, which finished the playoffs in 2020 with no positive COVID-19 cases.
Last fall, Cue got a $481 million investment from the Department of Defense to scale up its system. In early September, the company filed for an IPO (as such, no one from Cue was available to comment for this article, as it’s in the SEC lockup period).
As of August 31, Cue has shipped more than 115,000 readers and is manufacturing cartridges at a rate of 15 million a year, a figure it expects to significantly increase. While the COVID-19 diagnostic test may have been its first product, the company sees countless areas in which to expand, and has its sights set on tests for everything from cardiac health to STDs—several of which it plans to roll out next year.
See more from Fast Company’s 2021 Innovation by Design Awards. Our new book, Fast Company Innovation by Design: Creative Ideas That Transform the Way We Live and Work (Abrams, 2021), is on sale now.