The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
The companies are positioning the test, called SeptiCyte Rapid, for use in triaging COVID-19 patients who could be at greater risk for progressing to sepsis.
CNN reports that a US Food and Drug Administration document says Johnson & Johnson's SARS-CoV-2 vaccine meets the requirements to receive an Emergency Use Authorization.
In Cell this week: analysis of fitness patterns among SARS-CoV-2 isolates, single-cell transcriptome analysis of immune features in COVID-19, and more.