Democratizing diagnostics with a focus on portable COVID-19 testing.
CEO: Ayub Khattak
Based: San Diego, California
The scoop: Cue Health had been focusing on new tests for influenza, but the pandemic created new opportunities. Its point-of-care COVID-19 test—designed to provide a fast turnaround time similar to an antigen test—became the screener of choice for the NBA and its player-protecting "Bubble."
What makes Cue Health fierce: Cue has grown massively during the past 12 months. The diagnostics company has gone from just shy of 100 employees to over 600 and continues to grow. This includes active recruitment for its manufacturing operations and other company functions once production is in full gear.
It also got off a major $100 million funding drive in the summer of last year, building on a $13 million contract in March from the U.S. Biomedical Advanced Research and Development Authority, also known as BARDA.
Cue has worked with BARDA since 2018, following a $30 million contract to develop a test for influenza A and B for use at the point-of-care or at home through an online service. That test is currently undergoing clinical testing.
Then there was the major contract: In October 2020, the U.S. Department for Health and Human Services and the Department of Defense awarded Cue $481 million, which enabled the company to expand its industrial base and U.S. production capacity.
The BARDA and HHS/DOD contracts—plus a separate $100 million funding round—all spurred from its swift response to the pandemic in the form of its Cue COVID-19 Test.
Authorized by the FDA in June, Cue’s handheld diagnostic uses nasal swabs and a cartridge-based reader that delivers results to a connected smartphone app in about 20 minutes. As a highly sensitive and specific nucleic acid amplification test, it aims to offer a more accurate complement to the first-line screening provided by rapid antigen tests.
The test cartridge is a single-use, self-contained unit that applies the reagents and associated materials required for molecular detection of the SARS-CoV-2 virus that causes COVID-19.
Late last year, this diagnostic test was used by the NBA to screen players and was also shipped to five states through a government pilot program under the HHS. And the company is not resting on its laurels.
Cue told Fierce Medtech that it aims to deliver six million COVID-19 tests and 30,000 of its cartridge readers to the U.S. government this year to support the continued pandemic response.
“In addition to our contract with the federal government for 6 million tests, Cue is also focused on growing its business with healthcare and enterprise customers,” the company said. “Cue is expanding its facilities to be able to manufacture 100,000 tests per day.”
With its extra funding, Cue also began expanding its cartridge production operations at a new Vista, California facility in October of last year. There, Cue plans to hire at least an additional 500 employees, with more expected in the future.
While some companies have struggled to keep things running amid lockdowns and surges in viral activity, Cue has stayed operable the entire time. “We have been fortunate to keep our doors open, with our 600 employees able to come to work each day and ensure everyone’s safety with no outbreaks,” the company said.
Being a COVID testing company, it didn’t need to look far to achieve this. “We have done this by deploying our own testing at work. We test each employee daily in our CLIA-waived laboratory before they can go into our facilities. If we have any positive test result, we can advise the employee so he/she can seek care and quarantine appropriately ASAP. As a result, we have been able to continue to manufacture tests and get them out to the communities that need them.”
And just this month, Cue obtained a new, landmark authorization from the FDA: the agency’s first green light for a molecular COVID-19 test that can be performed at home, and without a prescription.
Investors: In June 2020 it raised $100 million in a Series C round backed by Decheng Capital, Foresite Capital, Madrone Capital Partners, ACME Capital, Johnson & Johnson Innovation and others, and was also awarded a $13 million contract from BARDA for a portable COVID-19 test. In October 2020, the DOD and HHS added a $481 million award to Cue to boost its capacity.