Minute Molecular Wins Contract to Expedite Manufacturing of Rapid COVID-19 Test

By Business Wire | 06.22.21

Assay allows highly sensitive PCR testing to take place at the point-of-care, and outside the traditional laboratory environment.

Minute Molecular Diagnostics Inc., (Minute Molecular) has been awarded a $21.3 million contract from the U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative for the company’s DASH (Diagnostic Analyzer for Specific Hybridization) point-of-care PCR system for COVID-19 testing. The contract supports further development of Minute Molecular’s DASH SARS-CoV-2 test, which allows highly sensitive PCR testing to take place at the point-of-care, and outside the traditional laboratory environment.
“We are pleased to receive support from NIH through the RADx initiative to scale our innovative technology during this critical time of need,” said Dr. David Kelso, co-founder, president, and CEO of Minute Molecular Diagnostics. “DASH performs point-of-care PCR testing for COVID-19 in approximately 15 minutes, providing an important, new tool for safely re-opening K-12 schools, universities, and workplaces.”

The DASH system is the result of collaboration between Northwestern University’s Center for Innovation in Global Health Technologies (CIGHT) and Minute Molecular. The RADx Tech contract will enable the development and manufacturing scale up of a highly sensitive COVID-19 detection system.
“DASH enables non-laboratory personnel to insert a nasal swab specimen directly into our test cartridge and then load the cartridge into the DASH instrument, providing an accurate result in about 15 minutes,” said Dr. Sally McFall, co-founder and chief scientific officer at Minute Molecular. “The simplicity of the DASH test allows PCR testing to go where antigen tests go now.”
Distribution of COVID-19 diagnostics, including DASH, in the United States are contingent upon receipt of Emergency Use Authorization from the U.S. Food and Drug Administration. This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, under Contract No. 75N92021C00013. Initial support was provided by the NIH Point-of-Care Technology Research Network (POCTRN), the Johns Hopkins Center for STD Point-of-Care Tests (JHU POCT), the Center for Innovation in Point-of-Care Technology for HIV/AIDS at Northwestern University (C-THAN), the Northwestern University McCormick Catalyst Award, and Minute Molecular Investors. Minute Molecular acknowledges the essential assistance of the NIH in making Point-of-Care PCR COVID-19 testing an effective reality.
Minute Molecular was founded in 2017 as a spin out of the Northwestern University Center for Innovation in Global Health Technology (CIGHT). Comprised of a management team with extensive diagnostic industry experience, the company has developed DASH—an innovative point-of-care PCR testing system that is able to provide central lab precision in approximately 15 minutes. The DASH platform is adaptable to other infectious viral and bacterial agents (Flu A/B, RSV, HIV, STDs, MRSA, Cdiff.), sample types (nasal swab, saliva, whole blood, etc.), and can also quantitatively report a viral load (HIV).