Beyond its HostDx Sepsis test, the firm is working on a test to detect and differentiate bacterial from viral infections in patients presenting with fever.
The CMS ruling follows the release of data showing strong performance of the test, including its ability to detect bloodstream pathogens missed by blood culture.
The Branford, Connecticut-based startup plans to seek US Food and Drug Administration clearance for and launch its instrument and first assays in 2021.
The iC-GN Assay detects target DNA and identifies gram-negative organisms associated with gram-negative bacteremia, and three antibiotic-resistance markers.
Within the "Big Three" conditions, misdiagnoses related to stroke, sepsis, and lung cancer accounted for the most high-severity diagnostic error cases.
iCubate said that it now has a comprehensive solution within European markets for the detection of bloodstream bacteria and important resistance markers.
