Research & Development
FDA Issues Emergency Use Authorization for MatMaCorp's COVID-19 2SF RNA Test for the Detection of SARS-CoV-2
12 January 2021 - - The US Food and Drug Administration has granted Emergency Use Authorization of US-based molecular diagnostic systems developer MatMaCorp's (Materials and Machines Corp.) COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company's Solas 8 portable detection system, the company said.

MatMaCorp is the first company announced by the National Institutes of Health to exclusively focus on expanding COVID-19 testing in rural areas, as part of the NIH's USD 1.5bn Rapid Acceleration of Diagnostics initiative.

The NIH launched the RADx initiative specifically to support the development and commercialization of innovative technologies to increase the US testing capacity for SARS-CoV-2, the coronavirus that causes COVID-19.

The funding will help scale MatMaCorp's COVID-19 testing solutions for use in association with CLIA labs at critical access hospitals, health systems, and mobile sites.

MatMaCorp is dedicated to providing its COVID-19 testing solutions to many regions in rural America, starting with Nebraska and expanding to Iowa, Kansas, North Dakota and South Dakota.

The Centers for Disease Control and Prevention have advised that rural communities may be at higher risk during the COVID-19 pandemic.

According to the CDC, an estimated 46 m Americans live in rural areas, where there are fewer medical facilities to provide care during the COVID-19 pandemic.

There are approximately 300 critical access hospitals in the four-state region that encompasses Iowa, Kansas, Nebraska, North Dakota, and South Dakota.

MatMaCorp's COVID-19 2SF RNA test and Solas 8 portable detection system are designed to make COVID-19 testing accessible and cost-effective at CLIA-certified sites.

The portable testing platform can rapidly perform multiple RT-PCR assays and has been validated by six independent locations across the country.

MatMaCorp's COVID-19 2SF RNA test is an RT-PCR test intended to detect the genetic material of SARS-CoV-2 from nasopharyngeal swab specimens collected from patients suspected by their healthcare provider of having contracted COVID-19 and may be used by any lab that is CLIA-certified to perform high-complexity testing.

MatMaCorp's COVID-19 test has not been FDA cleared or approved. The test has been authorized by the FDA under an EUA for use by clinics and laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 USC. § 263a, to perform diagnostic tests.

The test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus (COVID-19) infection, not for any other viruses or pathogens.

The test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the authorization is extended, terminated or revoked sooner.


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