Tag Archives: LumiraDx

Jan. 2, 2024—Roche announced it has entered into a definitive agreement to acquire LumiraDx’s point-of-care technology platform business, which offers a range of immunoassay and clinical chemistry tests that can be stored at room temperature.

January 2022—LumiraDx announced a partnership with digital health nonprofit Audere to offer a COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA Star Complete assay to process self-collected samples. SARS-CoV-2 RNA Star Complete has received FDA emergency use authorization for use by authorized laboratories. Laboratories using SARS-CoV-2 RNA Star Complete will be able to integrate Audere’s HealthPulse@home into their systems.

December 2021—LumiraDx announced that the FDA’s emergency use authorization for its SARS-CoV-2 antigen test has been expanded to include screening of asymptomatic individuals. This claim builds on its existing claim that covers use of the test in individuals suspected of having COVID-19 by their health care provider within 12 days of symptom onset. The test received EUA in August 2020.

November 2021—LumiraDx has submitted the LumiraDx SARS-CoV-2 and Flu A/B Test to the Food and Drug Administration for emergency use authorization.

Nov. 5, 2021—LumiraDx announced that the FDA’s emergency use authorization for its SARS-CoV-2 antigen test has been expanded to include screening of asymptomatic individuals.

Oct. 18, 2021—LumiraDx has submitted the LumiraDx SARS-CoV-2 & Flu A/B Test to the Food and Drug Administration for emergency use authorization.