The firm said that its point-of-care antigen testing platform uses high-frequency bulk acoustic wave sensors to detect SARS-CoV-2 at low limits of detection.
The firm said that during independent laboratory testing, its assay had 100 percent sensitivity for detecting HIV-1 p24, anti-HIV-1, and anti-HIV-2 in positive samples.
Clinical Enterprises received EUAs for two molecular tests, including one that uses self-collected nasal swab samples, while Qorvo's test detects viral antigens.
The firm said its rapid antigen test provided 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, and it is developing a saliva-based version.
The test, which runs on Ortho's Vitros system, was first CE marked in October for use with nasopharyngeal swab specimens and certain viral transport media.
RADx-UP is funding multiple efforts to determine how marginalized groups, such as undocumented immigrants and those in rural areas, can access testing.
CA Healthcare Acquisition, a special purpose acquisition company, said the transaction will support the development of LumiraDx’s pipeline of more than 30 assays.
The firm said it has licensed an instrument-free rapid immunoassay from an undisclosed test manufacturer that has received FDA Emergency Use Authorization.
The test runs on DiaSorin's Liaison XL Analyzer and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.
