Cue Health Inc. scooped up $100 million in a series C round to support the launch of its rapid molecular testing platform. The funds will be used to finalize the development and validation of the Cue Health Monitoring System and Cue Test Cartridges, as well as to scale up manufacturing operations.

Founded in 2010, the San Diego startup has raised a total of more than $190 million in private and government funding. Investors in this latest financing included Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation and Acme Capital.

Ayub Khattuk, Cue’s co-founder and CEO, said the COVID-19 pandemic has punctuated the need for a rapid, user-friendly diagnostics platform that can be used in a variety of settings.

“Health care settings such as nursing homes, emergency departments and community health clinics need tools to allow them to access molecular test information immediately rather than waiting hours or days for lab results,” he said. “Cue is grateful that our team’s years of hard work and preparation have put us in a position to assist with the current and future threats.”

Portable platform enables at-home testing

The company is developing a portable, connected diagnostic platform for use both in the home and by clinicians that will enable fast and convenient access to health information via a series of self-serve tests. To perform a test, a nasal swab is taken and placed in a disposable cartridge, which is then inserted into a small analyzer. The hand-held test uses DNA/RNA amplification and immunoassay chemistry to convert the swab to digital information that is delivered to an app on a mobile device. Patients get test results within 15-25 minutes, depending on the condition being diagnosed. All testing is done at the point of care, with no need to ship samples to a lab.

Cue’s first test product, a molecular test to detect SARS-CoV-2, the virus that causes COVID-19, is currently under review by the U.S. FDA for emergency use authorization (EUA).

The company also is completing validation to support a regulatory submission for its portable system for at-home influenza A and B testing. When cleared, it will be the first at-home, molecular flu test providing quick results and telehealth connectivity, according to the company. A Cue spokesperson told BioWorld the company has not yet indicated a timeline for availability of the influenza test.

The COVID-19 and flu tests are just two of a range of infectious disease applications that are in Cue’s pipeline. In 2016, the company partnered with Janssen Pharmaceuticals Inc., a Johnson & Johnson company, to develop an HIV quantitative viral load test for use on its platform.

“Ultimately, broad distribution of the connected Cue platform to both health care professionals and consumers will enable a new model of rapid, on-demand diagnostic testing and enhanced telemedicine capabilities, changing the way important health information is accessed and acted on,” Khattak said.

Scale up of manufacturing

A portion of the series C funds are earmarked to expand Cue’s San Diego manufacturing facility, doubling its footprint from 55,000 square feet to 110,000 square feet.

In addition to roughly $160 million in private investments, Cue has captured about $30 million in government funding – the latest, a $13 million contract in March from HHS’ Biomedical Advanced Research and Development Authority (BARDA) to speed the development and validation of the COVID-19 test.

BARDA originally contracted with Cue in 2018 to develop a flu test for both over-the-counter and professional use. The base funding for that project was $30 million.

Cue is hardly the only company developing rapid, at-home and point-of-care tests. Last month, the U.S. FDA cleared the way for emergency use of Letsgetchecked’s COVID-19 Sure-track Test for signs of active SARS-CoV-2 infection. The polymerase chain reaction (PCR) nasal swab test is designed for use by at-risk individuals in the home and delivers results within 24 hours of the sample’s receipt at the company’s CLIA-certified lab.

And last week. London-based Memed Diagnostics Ltd. secured CE marking for its point-of-care blood test, which can distinguish between bacterial and viral infections in 15 minutes.

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