The U.S. government is investing $481 million in startup Cue Health Inc. to expand manufacturing of its rapid, point-of-care Covid-19 test, the U.S. Department of Health and Human Services and the Department of Defense said on Tuesday.
As part of the deal, Cue Health plans to ramp up production from several thousands of tests daily to about 100,000 of the assays each day by March. The vast majority of that production will go to the government, which is acquiring about 6 million of the single-use tests and 30,000 associated instruments.
Cue Health’s test got emergency clearance in June. It detects the virus’s genetic material with a test cartridge about the size of an Airpod case and reader that allow results on-site in about 25 minutes, read using a smartphone app. That makes for fast answers that are about as reliable as tests sent out to a lab, said Brett Giroir, an assistant health secretary leading the administration’s testing efforts.
“This is really an important niche to fill,” said Giroir, who went on to note that Cue Health’s test was used as part of the National Basketball Association’s screening strategy. “So if it’s good enough for LeBron, we want to democratize it and make sure it’s available to the American people.”
The move is aimed at getting the right tests to the right person at the right time, rather than expanding how many tests the U.S. can do, Giroir said.
The Tuesday announcement follows previous investments by the government into manufacturing capacity at fellow rapid test manufacturers Becton Dickinson and Co and Quidel Corp. Investments have also been made to manufacture swabs, used to collect patient test samples, in the face of widespread shortages earlier in the pandemic.
“Companies need money up front, particularly small companies,” Giroir said. “This is not Abbott or BD.”
Cue Health’s Covid-19 test came out of a 2018 collaboration with the Biomedical Advanced Research and Development Authority on an influenza test intended for a potential flu pandemic. The company adapted the platform earlier this year to meet the current public-health crisis.
The assay is able to detect genetic markers of the virus and is easy-to-use because the company has “done all the integration work, so it’s quite sophisticated internally, like an iPhone is,” said Cue Health Chief Executive Officer Ayub Khattak. “We’ve had limited supply and there’s been a lot of demand for it.”
The test can detect as little as 20 copies per swab of the genomic RNA of the virus, a very small amount, Khattak said.
Exactly where the Cue Health tests are deployed by the government will depend on where outbreaks are occurring, Giroir said. They will be used in settings where confirming test results on the spot is especially valuable, he said.
Giroir gave nursing homes as an example. The U.S. investment in Cue comes on the heels of concerns raised anew this month about Covid-19 antigen screenings, another kind of rapid test, producing false positives.
The Cue Health test could be used confirm a positive result produced by an antigen screening, though “not every nursing home is going to get this,” Giroir said. Rules about government acquisitions prevented officials from discussing it with partners like nursing home groups prior to the announcement, according to Giroir.
“This is not to replace antigen tests. This is a layer on top of antigen tests,” he said.