UPDATE: June 12, 2020: Cue Health on Friday said it has received FDA emergency use authorization for the its portable, point-of-care COVID-19 test. The EUA allows the test to be used anywhere under the supervision of qualified medical personnel. Cue's initial plan is to launch the test with select healthcare institutions and satellite centers, followed by nationwide deployment across a variety of healthcare settings. The company intends to seek additional FDA authorizations for use in settings such as the workplace, schools, and at home.

Dive Brief:

• Cue Health has raised $100 million to commercialize a fast, portable COVID-19 molecular test that is awaiting emergency use authorization by the FDA.

• In a statement posted Wednesday, the San Diego-based biotech said it will use the funding to double the size of its development and manufacturing operation to support the advancement of its products.

• The COVID-19 test, which received $13 million in support from BARDA in late March, is designed to detect the SARS-CoV-2 virus from a nasal swab sample within 25 minutes.

Dive Insight:

Cue established its rapid testing technology well before the outbreak of COVID-19. In 2018, the startup raised a $45 million Series B funding round and secured an initial $14 million from the U.S. government to develop over-the-counter, home-use influenza diagnostics. The government put up the money as part of its efforts to prepare for an influenza pandemic.

COVID-19 shifted the focus of pandemic preparations from influenza to the novel coronavirus, leading Cue to adapt its technology to the new pathogenic threat. Working with $13 million from BARDA, Cue has advanced its portable, 25-minute test for the SARS-CoV-2 coronavirus to the point that it is under review at FDA for emergency use.

The situation has attracted the attention of investors. Johnson & Johnson Innovation, Decheng Capital, Foresite Capital, Madrone Capital Partners, and ACME Capital were among the investors to put money into Cue’s $100 million Series C financing round.

With its SARS-CoV-2 test in the process of securing emergency use authorization, Cue will use the money to scale up its operations. Currently, the company works out of a 55,000-square-foot vertically integrated site in San Diego. Using the Series C funds, Cue plans to grow the site to over 110,000 square feet, giving it more space to develop and manufacture products including its COVID-19 test.

If the COVID-19 test is accurate and deployed at scale, it could provide a boost to efforts to control the virus while reopening the U.S. economy. Abbott’s ID NOW rapid point-of-care diagnostic, for one, can already deliver SARS-CoV-2 results in minutes, but it is beset by questions about its accuracy.

Cue contends the speed and ease of use of its product will facilitate widespread testing in a range of settings, enabling organizations of all types to open their doors while mitigating the risk of viral spread.

“We plan to equip thousands of clinics, schools, eldercare facilities and homes with affordable, rapid and accurate testing capabilities. That infrastructure would enable on-demand diagnostic testing for families, and in the case of a viral or other biothreat, the ability to monitor a global, connected network producing real-time epidemiological data,” Cue CEO Ayub Khattak said in a statement.

The company can only realize that vision if its test is accurate and reliable. A high false negative rate could lead to sites such as eldercare facilities letting in people infected with the coronavirus, for example. Cue has yet to share details of the specificity and sensitivity of its test. That information will become available if the product receives FDA emergency use authorization.