2nd July 2019 Product update: iCubate
CE Marked iC-GN Assay™ - ID and Resistance Markers from Positive Blood Cultures
The iC-GN Assay from iCubate® is an in vitro diagnostic test for the detection and identification of pathogenic gram negative bacteria and clinically relevant resistance markers associated with bloodstream infections and subsequent sepsis. Identification occurs directly from a positive blood culture specimen in less than 4 hours, decreasing the time to appropriate antimicrobial therapy and improving patient outcomes.
Now with CE IVD Mark confirming that the iC-GN Assay meets the Essential Requirements of the European Directive on In Vitro Diagnostic Medical Devices. With the iC-GN Assay™ and the iC-GPC Assay™ (CE Marked in 2017), iCubate has a comprehensive solution for the detection of bacteria and important resistant markers associated with bloodstream infections within the European market. The CE Mark allows iCubate to market in over three dozen European countries.
iCubate’s rapid multiplex assays provide reliable test results for common bacterial causes of bloodstream infections as well as the detection of major antibiotic resistance gene markers directly from a positive blood culture. The user-friendly assays require only 2 to
3 minutes of hands-on time and provide results within a clinically relevant timeline of 3-4.5 hours. With accurate diagnostic information, the clinician can make more informed therapy choices that improve patient outcomes and shorten hospital stays, thereby reducing institutional costs, which favorably impact antimicrobial stewardship programs. iCubate’s gram positive assay, the iC-GPC Assay, is U.S. FDA cleared, and the iC-GN Assay is currently under FDA 510(k) review. Additionally, iCubate is working with global partners to bring these assays to the Asia market.
For more information visit icubate.com
Date Published: 2nd July 2019
Source article link: https://icubate.com/icubate-announces-ce-ivd-mark-for-ic-gn-assay/
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.