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.
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.
Source: Company Press Release
