LumiraDx Receives FDA Emergency Use Authorization for its COVID-19 Antibody Test, Now Allowing COVID-19 Antigen and Antibody Testing on a Single Point of Care Platform
- LumiraDx SARS-CoV-2 Ab Test utilizes a combination RBD and S1 spike SARS CoV-2 antigen for the detection of total antibody (Ab) elicited in response to SARS-CoV-2 infection
- Test can be run with fingerstick blood in CLIA Waived point of care settings, such as physician office and pharmacy, and provides digital results in 11 minutes
- Frederick National Laboratory for Cancer Research, a center sponsored by the National Cancer Institute (NCI), evaluation reported 100% sensitivity and 100% specificity, when comparing the LumiraDx SARS-CoV-2 Ab test against a standard reference panel
- Providing the LumiraDx SARS-CoV-2 Ab test and the LumiraDx SARS-CoV-2 Ag test, on a single point of care Platform, may help to more effectively aid in the diagnosis and management of COVID-19
London, UK (August 5, 2021): Today, LumiraDx, a next-generation point of care diagnostics testing company announced it has received FDA Emergency Use Authorization (EUA) for its SARS-CoV-2 Ab test. The test, which detects antibodies to SARS-CoV-2, is intended to be used to help identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The LumiraDx SARS-CoV-2 Ab test has been commercially available in Europe since achieving CE mark in September of 2020.
Run on LumiraDx’s high sensitivity Platform with results available in 11 minutes, the test combines accuracy and speed at the point of care.
- In clinical studies, the LumiraDx SARS-CoV-2 Ab test demonstrated 100% positive and negative agreement in samples collected from 8 days post RT-PCR test.
- In an independent study performed at the Frederick National Laboratory for Cancer Research (FNLCR), a center sponsored by the National Cancer Institute (NCI), the LumiraDx SARS-CoV-2 Ab test demonstrated 100% sensitivity and 100% specificity for detection of IgM and IgG antibodies against SARS-CoV-2 in serum and plasma samples.
Ron Zwanziger, LumiraDx CEO commented, “We know providing results at the point of care can make an incredible impact on the control of this virus and health of our communities. We have seen this impact firsthand with our SARS-CoV-2 Antigen test which received an EUA last year. Now, with the addition of our Antibody test on the LumiraDx point of care Platform, we believe we can make it even easier for healthcare providers to provide the best in COVID testing to their patients by providing fast and trusted results to support treatment decisions.”
New uses for the antibody test are arising as different ways emerge in how the virus is spreading and being treated. LumiraDx has on-going research programs contributing to the understanding of antibody testing in serosurveillance and vaccination programs.
Dr. Paul Drain, Associate Professor of Global Health, Medicine (Infectious Diseases), and Epidemiology at the University of Washington explained, “The LumiraDx SARS-CoV-2 Ab test delivers rapid, lab-comparable performance at the clinical point of care. In the current stage of the global pandemic, when nations are dealing with varying rates of infection, vaccination and risk of variant spread, we need many more testing and surveillance options. Antibody testing builds on current diagnostic testing programs to create solutions for surveillance of COVID-19 infection and seropositivity at an individual as well as a population level.”
LumiraDx Covid-19 Testing Supply Update
With its new manufacturing facility in Glasgow, LumiraDx has increased production capacity to 28 million total tests per month. With this, the company is able to provide sufficient capacity to meet current and growing demand for its portfolio of tests.
EUA Status of 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.
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 point of care diagnostic Platform that supports a broad menu of tests with lab comparable performance, as well as a testing technology designed for high-complexity laboratory testing. LumiraDx’s diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, pharmacy, schools, and workplaces to screen, diagnose and monitor wellness as well as disease. Based in the UK with more than 1500 employees worldwide, The Company 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 LumiraDx.com
Information about the product may be found at LumiraDx SARS-CoV-2 Ab Test - Instructions for Use (fda.gov)