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Abbott

Under the clearance, capillary whole blood is no longer an acceptable sample type for the company's Blue i-Stat CG4+ cartridge.

Policymakers have touted such tests as key to easing shutdowns, but high specificity will be needed to avoid misinforming people about their infection status.

The company is working to develop another lab-based serology test to detect IgM antibodies in people who have already had the virus.

Though its overall diagnostics revenues fell year over year, its molecular diagnostics business had a strong quarter with sales growth of 29 percent.

The new rate applies to clinical diagnostic lab tests using high-throughput technologies that can process more than 200 specimens per day.

Seegene said Monday that the Health Canada approval will enable hospitals and licensed labs there to run the assay immediately for high-volume testing.

News items for the in vitro diagnostics industry for the week of March 30, 2020.

Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.

The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.

The test will run on the m2000 RealTime molecular system, and the company said it will be shipping 150,000 tests immediately.

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