https://www.siliconvalley.com/2022/01/21/santa-cruz-company-gets-on-fda-fast-track-for-pathogen-sequencing-method-approval/

SANTA CRUZ – Pathogenomix, a Santa Cruz-based infection diagnostic and sequencing company, received a Breakthrough Device Designation from the U.S. Food and Drug Administration for its most recent pathogen sequencing procedure.

Nearly 3,000 devices receive approval from the FDA each year, according to Pathogenomix Chairman Chris Risley, but only 75 receive a Breakthrough Device Designation.