Cue Health to develop omicron-specific portable COVID test with BARDA backing

Cue Health is working to develop an omicron-specific COVID-19 test to help healthcare professionals quickly identify the variant through a project backed by the U.S. government.

With funding from the Biomedical Advanced Research and Development Authority, better known as BARDA, Cue aims to provide the targeted diagnostic alongside its current molecular COVID-19 test, which has been shown to detect all coronavirus variants including omicron. The new, cartridge-based, nasal swab test will also be compatible with the company’s portable reader.

Cue’s 20-minute nucleic acid amplification test relies on identifying a portion of the coronavirus’s genome that makes up its inner nucleocapsid protein—as opposed to the RNA that codes for its spike protein, which carries several mutations in the omicron variant.

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Following the rise of the delta variant last year—but before the emergence of omicron—Cue signed onto a project with Google Cloud to help connect its point-of-care tests and provide real-time data on the spread of new coronavirus strains.

The Fierce 15 winner’s system aims to provide public health officials with geographic information tracking COVID-19 cases—and, in the future, potentially keep tabs on other infectious diseases with separate tests for influenza and respiratory syncytial virus.

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When it comes to the new test, Cue is no stranger to BARDA and government funding. The company first received $30 million from the agency in 2018 to develop its initial, over-the-counter system for the flu and other respiratory diseases.

After pivoting to address the COVID pandemic, Cue received another $13 million in March 2020 to support its coronavirus work and secured an FDA emergency authorization for its test in June. It then won full over-the-counter approval in March 2021. In between, the company inked a $481 million contract with the Department of Defense to dramatically scale up production.