In the time it takes to get a pizza delivered, Minute Molecular Diagnostics’ COVID-19 testing kit can turn around back-to-back results for two separate nasal swab samples.
Thanks to that remarkable speed—and the accuracy of Minute’s PCR-based test—the National Institutes of Health (NIH) has awarded the company $21.3 million to accelerate the development and manufacturing of the test's cartridges and readers.
The funding comes from the NIH’s Rapid Acceleration of Diagnostics, or RADx, competition. A total of $1.5 billion has been set aside for the ongoing “Shark Tank”-style pitch competition, tasked with bringing the most innovative and effective COVID-19 diagnostics to market as quickly as possible.
With the proceeds, Minute will be able to rapidly scale up production of its coronavirus testing kits, though their distribution is still contingent on obtaining an emergency authorization from the FDA.
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Minute’s Diagnostic Analyzer for Specific Hybridization, or DASH system, includes a tabletop device that reads inserted nasal swabs and returns results in about 15 minutes.
The samples, which can be taken from both symptomatic and asymptomatic individuals, are enclosed in single-use test cartridges imprinted with QR codes for data collection and tracking purposes.
Because the entire testing process can be completed without the use of specialized lab equipment or personnel, the DASH system is ideal for use in point-of-care settings like K-12 schools, universities, businesses and healthcare facilities, David Kelso, Minute’s president, CEO and co-founder, said in a statement.
“The simplicity of the DASH test allows PCR testing to go where antigen tests go now,” co-founder and CSO Sally McFall said.
The testing kit was designed by Minute Molecular and Northwestern University’s Center for Innovation in Global Health Technologies, from which the company spun out in 2017.
Though their primary focus is now on COVID-19 testing, the organizations have also been working on expanding the DASH system’s capabilities to include PCR tests for the flu, HIV viral load, hepatitis C and several sexually transmitted infections.
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Minute’s testing system joins dozens of other COVID-19 diagnostics that have received funding through the NIH RADx project since its launch nearly a year ago. Two other testing kits have received funding this month, both of them antigen tests that produce results in about 20 minutes.
Qorvo Biotechnologies received almost $24.4 million for its antigen test that determines results using an acoustic biosensor and must be operated by a trained healthcare professional, while Mologic nabbed about $11.8 million for a nasal swab self-test that requires no professional training to operate or read.