Pathogenica, Inc., has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection sequence-based infectious disease diagnostic kit, which runs on the Ion PGM benchtop sequencer. “The kit and interpretation software system provides clinicians with a diagnostic tool for the identification of disease-causing bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe,” says Yemi Adesokan, Pathogenica's CEO.
The HAI BioDetection CE-IVD kit enables identification of the causative agents of 95% of nosocomial infections, so clinicians can rapidly take appropriate precautions for patients. The assay identifies the pathogen and includes a broad panel of 10 resistance genes (including mecA, vanA, KPC, and TEM), enhancing a clinician's ability to choose the appropriate antimicrobial therapy and practice proper antibiotic stewardship.
The HAI BioDetection CE-IVD kit prepares samples for sequencing from DNA extracted from isolates, colonies, positive blood culture, urine, rectal swabs, and stool. This allows the assay to identify pathogens associated with enteric diseases, bloodstream infections, and respiratory disorders. It requires no pre-culturing for urine, rectal swabs, and stool, enabling a streamlined lab workflow and clinically actionable turnaround (12 hours from DNA extraction to results).
In validation testing, the HAI BioDetection CE-IVD kit demonstrated a 100% correct identification rate for 771 bacterial samples. From specific clinical specimens, it identified 100% of Enterococcus positive rectal swabs, with an 89% detection rate of vanA, and achieved 92% concordance with microbial culture from stool for a broad set of bacterial targets. Learn more about the HAI BioDetection System.