The designation allows to use the test to identify infectious bacteria from sepsis and bacteremia, bacterial meningitis, joint and implant infections, and tick-borne bacterial infections
Pathogenomix has secured FDA breakthrough device status for Patho-Seq assay. (Credit: Belova59 from Pixabay)
Pathogen diagnostic company Pathogenomix has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Patho-Seq assay.
Patho-Seq has been developed for the detection and identification of hundreds of clinically relevant bacteria for a range of clinical conditions and sample types, including sepsis from whole blood samples and bacterial meningitis from CSF.
The assay has been granted breakthrough statue for the detection of infectious bacteria from sepsis and bacteremia, bacterial meningitis, joint and implant infections, and tick-borne bacterial infections.
The company’s customers in research institutions deploy the test for a range of sample source sites in the body, as well as for various pathogen ID’s.
Pathogenomix executive chairman Chris Risley said: “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.
“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.”
Through its targeted 16S sequencing approach, the Patho-Seq test holds the capacity to significantly improve infectious disease treatment.
The test is believed to address the critical weaknesses of current FDA-approved methods for the diagnosis of inpatient bacterial infections, as it is a rapid and hypothesis-free diagnostic that can detect any of hundreds of bacteria.
Compared to the currently approved standard of care tests, the Patho-Seq test can deliver results more than 48 hours faster, the company said.
Pathogenomix stated that it has collaborated with Mayo Clinic on the development of the techniques and data that supported the application for the breakthrough designation.