Business & Finance
Minute Molecular's DASH Point-of-Care COVID-19 Rapid PCR Test Gains FDA Emergency Use Authorization
16 March 2022 - - The US Food and Drug Administration granted an Emergency Use Authorization for US-based Minute Molecular Diagnostics' rapid DASH SARS-CoV-2/S Test, the company said.

Minute Molecular's polymerase chain reaction 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.

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.

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.

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.

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.

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 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.


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