LumiraDx Announces US Launch of its Rapid Onsite COVID-19 Surveillance Test
Works with easy-to-use portable instrument; allows pooling of 5 samples at one time; digital results in less than 12 minutes from sample application; $4 per sample
London, UK (September 2, 2021) Today, LumiraDx, a next-generation point of care diagnostics testing company, announced the US launch of its COVID-19 Surveillance Test, for environments such as schools and workplaces. The LumiraDx SARS-CoV-2 Ag Surveillance Test allows simultaneous testing of up to five samples on a small, portable instrument with cost per sample as low as $4. With digital results in less than 12 minutes from sample application and a comprehensive connectivity solution, it is designed to measure population health metrics in real-time to help prevent the spread of infection using an affordable, easy-to-use, onsite testing platform. LumiraDx’s announcement comes at a time when schools across the U.S. are assessing how to both bring students back to in-person learning while also monitoring for outbreaks to ensure they can stay safe and open.
The company also offers the LumiraDx SARS-CoV-2 Ag Test and SARS-CoV-2 Ab Test for clinical use in CLIA waived settings on the LumiraDx Platform, both of which were granted Emergency Use Authorization by the FDA.
The LumiraDx SARS-CoV-2 Ag Surveillance Test, used on the LumiraDx Platform, has demonstrated 100.0% positive agreement and 96.6% negative agreement with its comparator, the LumiraDx SARS-CoV-2 Ag Test. It allows rapid, high-sensitivity surveillance testing in both CLIA and non-CLIA certified settings.
Pooja Pathak, LumiraDx Chief Product Officer explained, “Our rapid onsite COVID-19 Surveillance Test offers options that can fit into a variety of different use-cases to support a safe return to school or the workplace and instill confidence in groups about their environment. By pooling up to five samples at one time, the LumiraDx SARS-CoV-2 Ag Surveillance test provides an efficient, accurate and cost-effective way to implement a surveillance testing program.”
Details of LumiraDx’s COVID-19 diagnostic and surveillance testing options are also available through Open and Safe Schools, in partnership with The Rockefeller Foundation’s National Testing Action Program (NTAP), to support state public health and school leaders to leverage federal government programs and resources and implement school COVID-19 testing programs to safely reopen and stay open.
LumiraDx is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, the company manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx’s diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacy, schools, and workplaces to screen, diagnose and monitor wellness as well as disease. The company has on the market and in development 30+ tests covering infectious diseases, cardiovascular disease, diabetes and coagulation disorders, all on the LumiraDx Platform. In addition, the company has a comprehensive portfolio of fast, accurate and cost-efficient COVID-19 testing solutions from the lab to point of need.
Based in the UK with more than 1500 employees worldwide, LumiraDx is supported by institutional and strategic investors including the Bill & Melinda Gates Foundation, Morningside Ventures, U.S. Boston Capital Corporation, and Petrichor Healthcare Capital Management.
More information may be found at www.lumiradx.com
About The LumiraDx SARS-CoV-2 Ag Surveillance test
The LumiraDx SARS-CoV-2 Ag Surveillance Test is available in the U.S. and has been designed for surveillance purposes (i.e., to inform population or community-level decision-making on de-identified samples) only. The LumiraDx SARS-CoV-2 Ag Surveillance Test is not FDA authorized, cleared, or approved and can be used for surveillance purposes only. Public health surveillance testing results cannot be used for individual decision-making. FDA does not regulate surveillance tests and has not authorized this test for surveillance purposes.
More information may be found at www.lumiradx.com/us-en/what-we-do/surveillance
About the LumiraDx SARS-CoV-2 Ag test and LumiraDx SARS-CoV-2 Ab test
The LumiraDx SARS-CoV-2 Ag test and the LumiraDx SARS-CoV-2 Ab test have not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Ab test has been authorized by FDA under an EUA only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The tests are authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.