FDA Issues Emergency Use Authorization for MatMaCorp's COVID-19 2SF RNA Test for the Detection of SARS-CoV-2
MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of MatMaCorp's COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company's Solas 8® portable detection system. MatMaCorp is the first company announced by the National Institutes of Health (NIH) to exclusively focus on expanding COVID-19 testing in rural areas, as part of the NIH's $1.5 billion Rapid Acceleration of Diagnostics (RADx) initiative.
The NIH launched the RADx initiative specifically to support the development and commercialization of innovative technologies to increase the U.S. 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.
Dr. Abe Oommen, MatMaCorp founder and President, said, "As a diagnostics company founded and headquartered in Nebraska, we are committed to serving our rural and agricultural communities. With the financial support and regulatory guidance from NIH and the RADx initiative, and now with FDA Emergency Use Authorization, we can help increase COVID-19 testing for our underserved communities that feel left behind."
The Centers for Disease Control and Prevention (CDC) have advised that rural communities may be at higher risk during the COVID-19 pandemic.1 According to the CDC, an estimated 46 million Americans live in rural areas, where there are fewer medical facilities to provide care during the COVID-19 pandemic.2 There are approximately 300 critical access hospitals in the four-state region that encompasses Iowa, Kansas, Nebraska, North Dakota, and South Dakota.
"Critical access hospitals play a pivotal role in serving our rural communities, but they are currently hindered by lack of onsite testing, limited allocation of tests, and high costs of current devices," said Phil Kozera, CEO at MatMaCorp. "To help improve care in our rural communities, we plan to provide our COVID-19 tests and platform to CLIA labs at select critical access hospitals starting with Nebraska and expanding in the central United States. MatMaCorp's COVID-19 2SF RNA test and Solas 8 portable device are ideally suited to provide reliable resuls for surveillance and routine testing."
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 (News - Alert) 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.
For more info on MatMaCorp's COVID-19 testing solutions, click here.
This project has been funded in whole or in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No: 75N92020C00019.
About Emergency Use Authorization Status
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 ("CLIA"), 42 U.S.C. § 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 U.S.C. § 360bbb-3(b)(1), unless the authorization is extended, terminated or revoked sooner.
MatMaCorp (Materials and Machines Corporation) is a developer of comprehensive solutions for science, medicine, and agriculture. By combining engineering, life science, and information technology, MatMaCorp has developed a portable, easy-to-use, and affordable suite of products to power human diagnostics, animal conservation, and agriculture applications, including food safety and breeding. Commercially available tests include: A2, African swine fever, bovine congestive heart failure (BCHF), and porcine reproductive and respiratory syndrome virus (PRRS). For more information, please visit www.matmacorp.com and follow the company on Twitter and LinkedIn.