FDA approves NGS assay for identifying bacteria

Jan. 20, 2022

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for a next-generation-sequencing assay from Pathogenomix.

The Patho-Seq assay is designed for the rapid detection and identification of hundreds of bacteria for a broad list of clinical conditions and sample types, including sepsis from whole blood samples and bacterial meningitis from CSF, Pathogenomix said.

However, the FDA approval was specifically for the identification of infectious bacteria from sepsis and bacteremia, bacterial meningitis, joint and implant infections, and tick-borne bacterial infections.

"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," said Chris Risley, Executive Chairman of Pathogenomix.

Mayo Clinic, which partnered with Pathogenomix in the development of the technology, has a financial interest in it.

Founded in 2016, Pathogenomix is a privately held company providing SaaS online software tools and lab protocols for the rapid identification of pathogens via DNA/RNA sequencing of the pathogen's genome.

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