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The technology underlying the test was developed by Dutch firm Minicare, which was acquired by Siemens in 2019.
The chemiluminescent immunoassay may be used by laboratories CLIA-certified to perform moderate- or high-complexity tests, the FDA said.
The tests are expected to become widely available to consumers through supermarket chains, drug stores, pharmacies, and online sales starting March 6.
While serology has been little used throughout the pandemic, the vaccine rollout presents new opportunities both for research and clinical use.
The company said that it has submitted the high-throughput antigen test to the US Food and Drug Administration for Emergency Use Authorization.
Roche Diagnostics obtained a claim expansion for its Cobas CT/NG assay, which uses real-time PCR to detect Chlamydia trachomatis and Neisseria gonorrhoeae DNA.
The companies recently signed a North American distribution agreement for Siemens Healthineers' automated urine chemistry analyzer.
The firm said its Diagnostics fiscal Q1 revenue rose in part because of the increase in antigen test sales while routine testing also returned to normal levels.
The firm said it saw a significant contribution from pandemic-related products including €130 million in revenue from its rapid antigen test.
Exact Sciences discussed newly released data and its plans for Cologuard, while Luminex provided details about its warning letter from the FDA.