Nanopath Secures FDA Breakthrough Device Designation for Rapid Molecular Test for Complicated UTIs
Nanopath has been granted FDA Breakthrough Device designation for its point-of-care molecular assay designed for patients with suspected or at-risk complicated urinary tract infections. The designation recognizes the platform’s potential to speed up diagnosis by delivering actionable results within a single visit, helping clinicians make timely treatment decisions without relying on centralized laboratory testing.
The regulatory milestone gives Nanopath access to the FDA’s accelerated review framework, which is intended for technologies that may significantly improve care for serious or debilitating conditions. Amogha Tadimety, co-founder and co-CEO, said, “Receiving Breakthrough Device designation is an exceptional recognition of Nanopath’s technology and its potential to transform how UTIs are diagnosed.” Co-founder and co-CEO Alison Burklund added that the designation “underscores the strength and innovative nature of our platform” and supports the company’s goal of expanding access to rapid molecular diagnostics.
Complicated UTIs remain one of the world’s most common infections and are often challenging to diagnose quickly with existing laboratory-based methods. Nanopath’s platform aims to identify causative pathogens and detect key antibiotic resistance markers directly from a urine sample in about 15 minutes. The cartridge-based system is designed for use in outpatient settings, offering clinicians immediate insight that could reduce delays in starting appropriate therapy and limit unnecessary antibiotic prescribing.
Edward Evantash, chief medical officer at Nanopath, noted the current gap in diagnostic options, saying, “No existing test today can provide this level of molecular insight for complicated UTIs during a patient encounter.” He emphasized that rapid, clear results could help patients avoid waiting days for culture-based findings before receiving targeted care.
The Breakthrough designation follows recent organizational expansion as the company grows its scientific and commercial teams. Supported by investment from Norwest and other funding partners, Nanopath plans to advance its platform toward FDA marketing authorization while preparing for broader clinical adoption.
