FDA grants breakthrough device designation to diagnostic test for cUTIs

The FDA has granted a breakthrough device designation to Nanopath’s diagnostic assay for the detection of infection in patients who have suspected, or are at risk of, complicated urinary tract infections (cUTIs), Nanopath announced in a news release.¹

Breakthrough device designation is granted to technologies that represent a meaningful advance in safety or effectiveness for life-threatening or irreversibly debilitating conditions. With this designation, the development pathway for the molecular test can benefit from more frequent feedback from the FDA as well as accelerated review.

"Receiving Breakthrough Device designation is an exceptional recognition of Nanopath's technology and its potential to transform how UTIs are diagnosed," said Amogha Tadimety, PhD, co-founder and co-chief executive officer of Nanopath, in the news release.¹ "It is incredibly rare for a diagnostic test—particularly in microbiology and women's health—to receive this distinction."

The test, if approved, would represent the first molecular platform for cUTI diagnosis at the point of care. The assay is designed to deliver actionable molecular results in approximately 15 minutes by analyzing cUTI-causing pathogens and key antibiotic resistance markers directly from a patients’ urine sample. According to Nanopath, this quick turnaround time would allow clinicians to “initiate appropriate therapy faster and avoid unnecessary or ineffective antibiotic use.”

"No existing test today can provide this level of molecular insight for complicated UTIs during a patient encounter. Nanopath's easy-to-use platform will report clear, actionable results, so that patients no longer have to wait days in pain before beginning targeted treatment," added Edward Evantash, MD, chief medical officer of Nanopath, in the news release.¹

In addition to the cUTI assay, Nanopath’s development pipeline also includes technology for vaginitis, sexually transmitted infections, and human papillomavirus.² All of these assays use a biosensor based on surface plasmonresonance, which the company says is the most sensitive biochemical assay available.

"This recognition and commitment from the FDA underscores the strength and innovative nature of our platform,” said Alison Burklund, PhD, co-founder and co-chief executive officer of Nanopath.¹ “It also marks an important step toward realizing our vision of making rapid molecular diagnostics broadly accessible in clinical settings worldwide.”

REFERENCES

1. Nanopath granted FDA breakthrough device designation for its molecular diagnostic platform for urinary tract infections. News release. Nanopath. November 18, 2025. Accessed November 18, 2025. https://www.prnewswire.com/news-releases/nanopath-granted-fda-breakthrough-device-designation-for-its-molecular-diagnostic-platform-for-urinary-tract-infections-302617775.html

2. Vision. Nanopath. Accessed November 18, 2025. https://nanopath.com/vision