This designation recognizes Nanopath’s potential to significantly improve patient outcomes by delivering actionable molecular results within a single office visit and empowering healthcare providers and patients to make informed treatment decisions at the point-of-care. It also represents a major regulatory milestone, providing Nanopath with an accelerated pathway toward FDA marketing authorization and commercial launch.

“Receiving Breakthrough Device designation is an exceptional recognition of Nanopath’s technology and its potential to transform how UTIs are diagnosed,” said Amogha Tadimety, Ph.D., co-founder and co-chief executive officer of Nanopath. “It is incredibly rare for a diagnostic test – particularly in microbiology and women’s health – to receive this distinction.”

“This recognition and commitment from the FDA underscores the strength and innovative nature of our platform. It also marks an important step toward realizing our vision of making rapid molecular diagnostics broadly accessible in clinical settings worldwide,” said Alison Burklund, Ph.D. co-founder and co-chief executive officer of Nanopath.