TUESDAY, JUNE 19, 2018

Pathogenca earns CE Marking for biodetection kit

Pathogenca, Inc., announced on Wednesday that is has received the CE mark under the European Directive for its HAI BioDetection kit.

The HAI BioDetection CE-IVD kit is the first sequence-based infectious disease diagnostic kit to be made available for sale. The kit is capable of identifying the causative agents of 95 percent of nosocomial infections ranging from bacterial organisms to resistance genes in a single assay. This process not only identifies pathogens, but also identifies a panel of 10 resistance genes.

"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," Yemi Adesokan, the CEO of Pathogenica, said. "Our team is proud to be supporting the evolving way healthcare providers will routinely manage patient care and treatment options."

The kit prepares samples for sequencing from DNA extracted from a large variety of sources, including colonies, positive blood culture, urine and stool, which makes it a good fit for identifying numerous pathogens. The samples require no pre-culturing.

"Thought leaders in infection control departments have been enthusiastic about our rapid high resolution test," Adesokan said. "Pathogenica produces clinically superior and actionable results more rapidly after sample collection than other technologies such as MALDI-TOF and PFGE, which require pre-cultured samples."