Karius has gained breakthrough designation from the FDA for its DNA-based blood test. The test, known as the Karius Test, is designed to detect ~1,000 different pathogens and has been commercially available since 2017. Currently, it is being used at ~400 locations across the US.
The Karius Test is used primarily in cancer centers to monitor immunocompromised patients suspected of having potentially fatal lung conditions. The test is able to identify infectious agents including bacteria, fungi, parasites, and viruses from blood samples. The Karius test was reportedly able to identify the probable cause of pneumonia in 12% of patients in clinical studies.
Karius operates in the life sciences sector, focusing on infectious disease diagnostics through genomic insights. Its Karius Test is a liquid biopsy test that non-invasively detects ~1,000 pathogens from a single blood sample. This test uses advanced genomics and AI to analyze microbial cell-free DNA, providing diagnostic information that enables rapid treatment decisions.
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