Pathogenomix’s Patho-Seq NGS Test Gains Breakthrough Status

Next-generation sequencing (NGS), pathogen diagnostic firm Pathogenomix was granted U.S. Food and Drug Administration (FDA) breakthrough device designation for its Patho-Seq assay.
 
Patho-Seq rapidly detects and identifies hundreds of relevant bacteria for a broad list of conditions and sample types, including sepsis from whole blood and bacterial meningitis from cerebrospinal fluid.
 
“Perhaps the most important advantage of using next-generation sequencing for bacterial ID is its ability to rapidly detect any of hundreds of infectious bacteria from a single test run, without requiring a specific hypothesis from the clinician about what might be causing the infection,” Pathogenomix Executive Chairman Chris Risley told the press. “In the other diagnostics, in order to select the correct growth medium or NAAT, the clinician must have a strong hypothesis about which one of hundreds of potential pathogens may be infecting their patient. The same breadth also allows multiple bacterial IDs from polymicrobial samples in cases where more than one species may be contributing to the infection. In addition, if a sample is taken after the patient has been treated with antimicrobials then traditional culture for ID often delivers a false negative. Patho-Seq can identify all bacteria even if the sample was taken after the patient was treated.”
 
Pathogenomix partnered with Mayo Clinic to develop the techniques and data supporting the application for FDA Breakthrough Device Designation. The Patho-Seq test could greatly progress infectious disease treatment via its targeted 16S sequencing approach.
 
Sepsis can arise from uncontrolled infections at many body sites from a massive variety of causative organisms. Current FDA-approved methods don’t address this breadth of causes with a single test. Patho-Seq is a rapid, hypothesis-free diagnostic that can spot hundreds of bacteria over 48 hours faster than currently approved standard of care tests. Patho-Seq was granted Breakthrough Device Designation to identify infectious bacteria from sepsis and bacteremia, bacterial meningitis, joint and implant infections, and tick-borne bacterial infections.
 
Mayo Clinic has financial stake in this technology and will use revenue it gains for its non-profit patient care, education, and research mission.