Pathogenomix’s Patho-Seq Assay Designated an FDA Breakthrough Device

The FDA has granted its Breakthrough Device designation to Pathogenomix’s Patho-Seq assay, a rapid bacteria test that can detect clinical conditions from different sample types, such as sepsis from whole blood samples and bacterial meningitis from cerebrospinal fluid.

The assay can 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, the company said.

Pathogenomix collaborated with the Mayo Clinic in developing the techniques and data that supported the Breakthrough Device designation.