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Based on the results of the new studies, the Norwegian company is positioning its calprotectin test as an alternative to conventional ELISAs.
The company said that its Access Interleukin-6 assay is designed to assist physicians in the identification of severe inflammatory response in COVID-19 patients.
The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.
The CE mark advances the firm's strategy to develop and commercialize two- to five-minute tests that use fingerprick blood or stool samples, ProciseDx said.
ProciseDx anticipates bringing rapid, quantitative point-of-care tests to market in 2020 using Lumiphore's metal luminescent reporter technology.
The point-of-care test will use the companies' respective technologies and detect two protein biomarkers of inflammation and immune system activity.
The "drug-tolerant assay" found that only very early TNF levels offered treatment response clues in RA patients treated with the TNF inhibitor adalimumab.
ProAxsis and a US-based biotechnology company codeveloped the assay as part of an ongoing collaboration. ProAxsis has made its first commercial sale of the test.
Ortho said it will initially launch Sentinel's wide-range C-reactive protein assay in North America, Europe, Africa, and the Middle East.
FlowMetric said that by combining products, the partners will provide consumers with data security and the ability to govern how their personal information is shared, utilized, and monetized.