FDA Issues Emergency Use Authorization for MatMaCorp's COVID-19 2SF RNA Test for the Detection of SARS-CoV-2

FDA对MatmacorpCovid-19 2SF RNA检测新型冠状病毒的紧急使用授权

2021-01-13 07:32:15 BioSpace


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 results 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 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. About MatMaCorp 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. CDC: Why Rural Communities May Be at Higher Risk During the COVID-19 Pandemic, updated August 3, 2020, accessed January 11, 2021. CDC: Coronavirus Disease 2019 (COVID-19), Rural Communities, updated August 3, 2020, accessed January 11, 2021.   View source version on businesswire.com: https://www.businesswire.com/news/home/20210112005118/en/ Corporate Contact: Phil Kozera, 1.402.742.0357, info@matmacorp.com Media Contact: Jessica Yingling, Ph.D., Little Dog Communications, 1.858.344.8091, jessica@litldog.com Source: MatMaCorp View this news release online at: http://www.businesswire.com/news/home/20210112005118/en
NIH发起RADx计划的目的是支持创新技术的开发和商业化,以提高美国对新型冠状病毒病毒的检测能力,这种冠状病毒会导致Covid-19病毒。这笔资金将帮助扩大Matmacorps公司的COVID-19测试解决方案的规模,以便与CLIA实验室联合使用,用于关键接入医院,卫生系统和移动站点。MatMaCorp致力于向美国农村的许多地区提供其COVID-19测试解决方案,从内布拉斯加州开始,扩展到爱荷华州,堪萨斯州,北达科他州和南达科他州。 MatMaCorp创始人兼总裁Abe Oommen博士说,作为一家成立并总部设在内布拉斯加州的诊断公司,我们致力于为我们的农村和农业社区服务。有了NIH和RADx计划的财政支持和监管指导,现在又有了FDA的紧急使用授权,我们可以帮助我们服务不足,感觉落后的社区增加COVID-19测试。 美国疾病控制与预防中心(CDC)建议,在柯维德-19大流行期间,农村社区可能面临更高的风险。1根据CDC,估计有4600万美国人生活在农村地区,在柯维德-19大流行期间,农村地区提供护理的医疗设施较少。2在包括爱荷华州,堪萨斯州,内布拉斯加州,北达科他州和南达科他州在内的四个州地区,大约有300家关键医院。 Matmacorp公司首席执行官菲尔·科泽拉说:“危重准入医院在为我们的农村社区提供服务方面发挥着关键作用,但它们目前受到缺乏现场检测,检测分配有限以及当前设备成本高的阻碍。”为了帮助改善我们农村社区的护理,我们计划从内布拉斯加州开始,并在美国中部扩展,向选定的关键准入医院的CLIA实验室提供我们的COVID-19测试和平台。Matmacorps COVID-19 2SF RNA测试和Solas 8便携式设备非常适合为监测和常规测试提供可靠的结果。 Matmacorps公司的COVID-19 2SF RNA测试和Solas 8便携式检测系统旨在使COVID-19测试在CLIA认证的场所变得方便和经济。该便携式检测平台可快速进行多次RT-PCR检测,并已在全国六个独立地点得到验证。Matmacorps COVID-19 2SF RNA检测是一种RT-PCR检测方法,旨在从鼻咽拭子标本中检测新型冠状病毒病的遗传物质,该标本采集自被卫生保健提供者怀疑患有COVID-19的患者,并且可被任何获得CLIA认证的实验室用于执行高复杂度检测。 有关Matmacorps COVID-19测试解决方案的更多信息,请单击此处。 本项目全部或部分由卫生与公众服务部国家卫生研究院国家生物医学成像与生物工程研究所联邦基金资助,合同编号:75N92020C00019。 关于紧急使用授权状态 Matmacorps的COVID-19试验尚未获得FDA的许可或批准。该测试已由FDA根据EUA授权用于根据1988年临床实验室改进修正案(CLIA)(42 U.S.C.)认证的诊所和实验室。§263A,以执行诊断测试。该试验仅被授权用于检测来自新型冠状病毒病毒的RNA和诊断新型冠状病毒病毒(COVID-19)感染,而不是用于任何其他病毒或病原体。根据《联邦食品,药品和化妆品法》(21 U.S.C.)第564(b)(1)节的规定,在宣布存在证明有理由紧急使用体外诊断技术检测新型冠状病毒病毒的情况下,美国仅在这段时间内授权该试验。§360BBB-3(b)(1),除非授权提前延期,终止或撤销。 关于MatMaCorp MatMaCorp(材料和机器公司)是一家为科学,医学和农业提供综合解决方案的开发商。通过结合工程,生命科学和信息技术,MatMaCorp公司开发了一套便携,易用,价格低廉的产品,用于人类诊断,动物保护和农业应用,包括食品安全和养殖。商业上可获得的检测包括:A2,非洲猪瘟,牛充血性心力衰竭(BCHF)和猪繁殖与呼吸综合征病毒(PRRS)。欲了解更多信息,请访问www.matmacorp.com,并在Twitter和LinkedIn上关注该公司。 CDC:为什么农村社区在COVID-19大流行期间可能处于更高的风险,2020年8月3日更新,2021年1月11日访问。 CDC:冠状病毒病2019(COVID-19),农村社区,2020年8月3日更新,2021年1月11日访问。 在businesswire.com上查看源版本:https://www.businesswire.com/news/home/20210112005118/en/ 公司联系人:Phil Kozera,1.402.742.0357,info@matmacorp.com Media Contact:Jessica Yingling,Ph.D.,Little Dog Communications,电话:1.858.344.8091,电子邮件:Jessica@litldog.com 资料来源:MatMaCorp 在线查看此新闻稿: http://www.businesswire.com/news/home/20210112005118/en