iCubate, a molecular diagnostic device company, has received Food and Drug Administration clearance and the CE mark for the iCubate system and its first clinical test, the iC-GPC assay, a multiplexed test for the rapid detection and identification of pathogenic gram-positive bacteria associated with bloodstream infection. The iC-GPC assay is based on iCubate’s core technology, Amplicon-Rescued Multiplex polymerase chain reaction, which detects multiple pathogens concurrently and was developed by company founder and chief scientific officer, Jian Han, MD, PhD. Testing is performed directly from a positive blood culture in a closed and disposable cassette with results available in hours. The system identifies approximately 90% of organisms isolated from a blood culture, while identifying key resistance markers specific to the identification of methicillin-resistant Staphylococcus and vancomycin-resistant Enterococcus.