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FDA clearance

Tests that previously received FDA EUAs are either molecular, detecting viral nucleic acid, or serology tests that detect antibodies to the novel coronavirus.

The Euroimmun's Anti-SARS-CoV-2 ELISA test is the first serology test whose results were independently validated by the federal government.

The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.

Thermo Fisher's line of ImmunoCAP assays are designed to detect immunoglobulin E in order to identify allergic sensitization to a range of allergens.

Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.

BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.

If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.

The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.

The analyzer supports COVID-19 response efforts, where blood-gas testing plays a critical role in monitoring patients' respiratory distress, the firm said.

The analyzer and assay use immunofluorescent technology to detect H. pylori antigens in human stool and helps eliminate subjectivity.

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