LumiraDx continually monitors for new mutations in the SARS-CoV-2 viral genome as they arise to assess their potential impact on performance of our antigen and molecular products – LumiraDx SARS-CoV-2 Ag test, SARS-CoV-2 Ag Pool test (not available in the US) and LumiraDx SARS-CoV-2 RNA Star Complete and SARS-CoV-2 RNA STAR molecular tests.
Based on a detailed analysis of the specific mutations in the Omicron variant, we are confident that the performance of our antigen and molecular tests will not be impacted by these mutations.
We are also continually working with our global partners to collect and test clinical samples to supplement our ongoing variant testing activities and will share these results once available.
We are committed to providing quality and accessible products to meet our customers’ needs and our variant testing program is a critical part of this.
LumiraDx has significant manufacturing capacity to address an increase in global demand of tests due to the arrival of Omicron.
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.
LumiraDx SARS-CoV-2 Ag Pool Test is not available in the US
LumiraDx SARS-CoV-2 Ag Test has 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 test has not been authorized for use to detect any other viruses or pathogens. The test is 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.
The LumiraDx SARS-CoV-2 RNA STAR and SARS-CoV-2 RNA STAR Complete assay have not been FDA cleared or approved but have been authorized by FDA for emergency use under an EUA for use by authorized laboratories. These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products is only authorized 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.