Pathogenica has achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit that runs on the Ion PGM benchtop sequencer. This milestone marks the HAI BioDetection CE-IVD kit as the first sequence-based infectious disease diagnostic kit on the market.
"The kit and interpretation software system provides clinicians with a revolutionary diagnostic tool for the identification of disease-causing bacteria and accompanying antibiotic resistance markers in a clinically actionable timeframe," said Yemi Adesokan, Pathogenica's chief executive officer.
Healthcare associated infections (HAIs) are recognized as a severe health threat associated with increases in cost, morbidity and mortality. Intensive care units (ICUs) and other hospital wards with patients particularly susceptible to infection may benefit from advanced screening measures.
The HAI BioDetection CE-IVD kit enables identification of the causative agents of 95% of nosocomial infections in a single assay, enabling clinicians to rapidly take appropriate precautions for specific patients. The assay identifies the pathogen and also includes a broad panel of 10 resistance genes, enhancing a clinician's ability to choose the appropriate antimicrobial therapy and practice proper antibiotic stewardship. Studies have shown active surveillance to be a valuable component of a quality infection control program that enhances treatment decisions, improves patient care and reduces costs due to extended length of stay, unnecessary isolation and nursing time.
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 array of sample types makes Pathogenica's assay a fit for identifying pathogens associated with enteric diseases, bloodstream infections and respiratory disorders. Furthermore, the assay 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) for patients affected by urinary tract infections or enteric disorders.
"Culture independent sequencing is a great step forward for clinical applications," said Pathogenica co-founder George Church, prof. of genetics at Harvard Medical School. "Pathogenica has delivered a next-generation sequencing diagnostic tool that provides identification and antibiotic resistance information for improved infection control and therapeutic decision making."