NEW YORK – After spending the last eight years primarily in research and development, San Diego-based startup Cue Health has been thrust into full commercialization mode by the COVID-19 pandemic, with its SARS-CoV-2 test receiving significant interest from the US government.
The company received $481 million from the US Department of Defense in October to expand production capacity to provide 6 million of its SARS-CoV-2 tests and 30,000 readers by March of this year. Last March, the US Department of Health and Human Services Biomedical Advanced Research and Development Authority awarded the company $13 million to develop and validate its SARS-CoV-2 test.
In addition, researchers at Mayo Clinic recently published an independent clinical validation finding Cue Health's test demonstrated nearly 98 percent agreement compared to a central laboratory PCR test.
The test detects the SARS-CoV-2 N gene in nasal swabs and has received Emergency Use Authorization from the US Food and Drug Administration for use in CLIA-certified laboratories or at the point of care. Nasal samples are collected using Cue's Sample Wand swab, which is then inserted into a test cartridge that is coupled with the firm's Cue Health Monitoring System, providing results within 25 minutes through the company's free mobile app.
Heating, mixing, amplification, and detection all occur within the single-use cartridge when it is inserted into the battery-operated automated analyzer, which can run thousands of tests before it needs to be replaced, CEO Ayub Khattak said.
The current flow from electrodes in the reader provides "a semi-quantitative nanoampere measurement" that is converted to either a positive or negative result, based on a predetermined cutoff, according to the company's instructions for use.
The nucleic acid amplification test is currently being distributed in 10 states by the US DoD and HHS, although the company hopes to expand availability further, said Dulari Amin, Cue's head of marketing and communications. The tests have been distributed to nursing homes and educational sites, she added. Cue also provided onsite testing for the 2020 National Basketball Association season and has been distributed to healthcare providers by Henry Schein.
Bruce Lieberthal, Henry Schein's chief innovation officer, said the distributor called Cue directly after hearing its test had received EUA to partner with the company. He called the test "a bit of a godsend," emphasizing that it is "almost stupid-proof, if you will, to perform" with quick results, which "checked all the boxes" for what Henry Schein looked for in a SARS-CoV-2 test. The highest demand for Cue's test has been in the routine medical arena, such as urgent care centers, Lieberthal said, although dental companies and offices have also been using the test.
He added that Henry Schein has been ordering more than 10,000 tests per week and has shipped everything it has received from Cue. The only drawback of the test, Lieberthal noted, is that the reader is not high-throughput and only runs one test at a time, so the assay isn't the best option for a larger customer. "We can't get enough of it because the government is still taking quite a bit of it," Lieberthal said. "We have huge demand for the test, our customers absolutely love it."
Part of the test's appeal is its lower cost in comparison to pricier central lab tests. The portable reader costs "a couple hundred dollars," and the tests themselves costs "tens of dollars each," the company said.
The test's performance is also essential and is comparable to other point-of-care tests with sensitivity and specificity concordant with PCR molecular tests, Khattak said. Internal clinical studies performed for the company's EUA application have shown 99 percent sensitivity and 98 percent specificity to an EUA reference method, the company said.
In addition, a clinical evaluation by the Mayo Clinic Health System, published last month in Diagnostic Microbiology and Infectious Diseases, found the Cue test is a "feasible solution to implement at sites requiring a point-of-care solution," the company said in a statement.
The study was conducted at a community drive-through screening location in Minnesota with 292 patients who either had symptoms consistent with COVID-19 or had recent exposure to someone with SARS-CoV-2. Positive percent agreement between Cue's test and the reference PCR tests, the Hologic Aptima SARS-CoV-2 test and the TaqMan assay on the Roche Lightcycler 480, was nearly 96 percent, while negative percent agreement was 98 percent. The majority of the patients included in the study were symptomatic when they were tested, the researchers said.
Although Cue's test isn't yet authorized by the FDA for at-home use, that is the firm's ultimate goal, Khattak said. The test result is "natively digital," going directly to the patient's mobile device through the cloud, and is easy to do with no training, he added. The app allows users with a monitoring system to register for individual accounts and receive the test results.
"The electrochemical aspect really feeds into one of the key goals, which was having a digital result, rather than having somebody read it from their eye and therefore [have] it be like a lost result because it's not actually connected to the cloud at that point," Khattak said.
There are no fluids or pipettes required, because Khattak said the company wanted its test to be easily doable, specifically "less error prone" and "more broadly accessible" for users who are elderly, for example. The app also provides an alert to the user if the reader detects any errors that could lead to inaccurate results.
Using the money from the DoD and BARDA, as well as from a $100 million Series C financing last June, the company has expanded its facilities and is now able to manufacture 100,000 tests per day, Khattak said. Cue has expanded operations into another facility that will be used to produce the COVID-19 test cartridges, the company said.
Beyond COVID-19, Cue has a slate of other tests in development for its reader, such as influenza and other respiratory health tests. The cartridge is designed to do both nucleic acid amplification tests and immunoassays, and is capable of using different sample types, such as blood, urine, and oral fluid, all of which makes it possible to develop a broad menu, Khattak said.
In 2018, BARDA awarded the company up to $30 million to develop an influenza test and multiplex respiratory pathogen tests, and the company had started analytical and clinical validation for its at-home flu test before the COVID-19 pandemic began. The company is still validating its at-home flu test.