Minute Molecular Diagnostics has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its DASH SARS-CoV-2/S Test.
The new reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assay is designed for the rapid qualitative detection of RNA from SARS-CoV-2 using an anterior nasal swab.
It provides results in approximately 15 minutes and runs on the DASH Analyser, which consolidates the sample extraction and PCR.
The point-of-care technology was developed at the Center for Innovation in Global Health Technologies (CIGHT) of Northwestern University, Illinois. It is being commercialised by Minute Molecular Diagnostics.
The National Institutes of Health (NIH) provided $21.3m to the company for the manufacturing of the new DASH SARS-CoV-2/S Test.
Minute Molecular co-founder and chief scientific officer Dr Sally McFall said: “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.
“The simplicity of the DASH test adds an important, new tool for schools, universities, congregate care settings and workplaces.”
The company stated that the test is limited to use in Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified laboratories.
The DASH Covid-19 Rapid PCR test has received authorisation for use at the point of care (POC), for example in patient care settings that operate under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
Minute Molecular is starting its Covid-19 diagnostic test production as well as seeking both government and private partnerships to expedite test and analyser delivery.