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 updated test now includes additional susceptibility testing and clinical interpretive breakpoints that are compliant with 2019 European guidance.
The company also received a contract from the Henry M. Jackson Foundation for a separate sepsis test.
John McDonough announced he is moving into an executive chairman role and will step down as CEO. The firm has begun searching for a new CEO.
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 firm said it has entered exclusive agreements for distribution of its products in Estonia, Greece, Ireland, Saudi Arabia, and South Africa.
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.