|George Church, PhD|
Pathogenica Inc, Boston, has achieved the CE mark for its HAI BioDetection kit that runs on the Ion PGM™ benchtop sequencer.
This kit is the first sequence-based infectious disease diagnostic kit on the market, according to the company.
“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,” says Yemi Adesokan, CEO.
The 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 not only identifies the pathogen but also 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 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 the assay suitable for identifying pathogens associated with enteric diseases, bloodstream infections, and respiratory disorders – the key profile for HAIs in the United States and EU. The assay requires no preculturing 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,” says Pathogenica co-founder George Church, PhD, professor of genetics, Harvard Medical School, Boston, and co-founder of the company. “Pathogenica has delivered a next-generation sequencing diagnostic tool that provides identification and antibiotic resistance information for improved infection control and therapeutic decision making.”
THIS KIT IS NOT FDA APPROVED FOR IN VITRO DIAGNOSTIC TESTING IN THE UNITED STATES.
[Source: Pathogenica Inc]