Minute Molecular’s DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization

EVANSTON, Ill.–(BUSINESS WIRE)–Minute Molecular Diagnostics today announced that the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for its rapid DASH SARS-CoV-2/S Test. Minute Molecular’s polymerase chain reaction (PCR) test operates on a small instrument called the DASH Analyzer, which consolidates the entire PCR testing process (sample extraction and PCR) providing a result in approximately 15 minutes.

“We are pleased with the FDA’s decision and are ramping up our production to assist in the fight against COVID-19,” said Dr. David Kelso, co-founder, President, and CEO of Minute Molecular Diagnostics. “DASH provides central laboratory quality COVID-19 PCR results at the point of care in approximately the same time as an antigen test.”

“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 adds an important, new tool for schools, universities, congregate care settings, and workplaces.”

“What distinguishes DASH from existing options are its simplicity, speed, and PCR-level accuracy. The DASH interface walks the user through all the steps making it just as easy to use as a coffee maker. DASH is ideal for point-of-care testing in clinics, corporate, or community settings,” said Dr. Chad Achenbach, Associate Professor of Medicine (Infectious Diseases) and Preventive Medicine and lead of the DASH clinical evaluation.

“DASH offers the accuracy of other PCR tests in a compact portable platform that can be operated by non-technical personnel at the point-of-care in 15 minutes,” said Dr. Robert Murphy, the John Philip Phair Professor of Infectious Diseases at Northwestern University, and a member of the DASH clinical evaluation team.

Minute Molecular is beginning production of its COVID-19 diagnostic test and is seeking government and private partnerships to accelerate the delivery of the DASH SARS-CoV-2/S Test and Analyzer. Reservations are being accepted for a DASH analyzer by qualified laboratories at www.m2dx.com. Reserve your DASH today.

For the full FDA EUA letter, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-COVID-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. The DASH SARS-CoV-2/S Test is authorized for use at the point of care, such as patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

About Minute Molecular: Minute Molecular Diagnostics was founded in 2017 as part of the Northwestern University Center for Innovation in Global Health Technology (CIGHT). Comprising a strong management team with extensive diagnostic industry experience, Minute Molecular has developed DASH—an innovative point-of-care PCR testing system that provides central lab precision in approximately 15 minutes. The DASH platform may be adaptable to other infectious viral and bacterial agents (Influenza A/B, RSV, HIV, STDs, MRSA, C. difficile, etc.), sample types (nasal swab, saliva, whole blood, etc.), and can report a quantitative viral load (HIV).

The development of the DASH SARS-CoV-2/S Test has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx®) initiative with additional financial support from the NIH’s National Institute of Biomedical Imaging and Bioengineering. 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.

For more information, visit www.m2dx.com; Twitter: @MinuteMolecular

About Northwestern University Center for Innovation in Global Health Technologies (CIGHT): The Center for Innovation in Global Health Technologies research addresses the healthcare concerns for low- and middle-income countries. Through the development of point-of-care diagnostic devices, CIGHT is deeply involved in the following areas of study: HIV and its associated diseases, such as TB and other opportunistic infections, saving lives at birth, and training for local healthcare workers that allow them to effectively support the work of physicians and nurses.

The DASH SARS-CoV-2/S has not been approved or cleared by the FDA. This test has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Contacts

For more information, media only:
Wally Narajowski | wally.narajowski@m2dx.com