Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

Milestone clears path for rapid market entry of Nanopath's first-in-class point-of-care platform addressing a leading health condition

CAMBRIDGE, Mass., Nov. 18, 2025 /PRNewswire/ -- Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company's novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).

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.

The First Molecular Platform for cUTI Diagnosis at the Point-of-Care
Complicated UTIs (cUTIs) are among the most common infections worldwide, representing a major, highly underserved disease space and a multi-billion-dollar global market opportunity. Nanopath is developing the first molecular diagnostic platform capable of simultaneously identifying cUTI-causing pathogens and key antibiotic resistance markers at the point-of-care, in approximately 15 minutes, directly from a urine sample.

Unlike existing culture-based, laboratory-scale tests that can take several days to return a result, Nanopath's cartridge-reader solution is designed to deliver actionable diagnostic insights during an office visit. This enables clinicians to rapidly 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," said Edward Evantash, MD, chief medical officer of Nanopath.

The FDA's Breakthrough Devices Program is a voluntary initiative designed to accelerate the development, assessment and review of a select group of medical devices that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. The designation enables Nanopath to engage in early, frequent interactions with the FDA to support a clear pathway to commercialization.

"For too long, patients have waited days or even weeks for critical test results," said Jeff Crowe, senior managing partner at Norwest. "Nanopath is transforming diagnosis and care delivery by providing faster, more reliable results that clinicians can act on. With this FDA Breakthrough Device designation, the company is poised to scale its impact and growth in an area that desperately needs innovation."

Last month Nanopath announced expansion of the company's leadership team with five executives hired to fuel the company's scientific and commercialization growth.

Learn more about Nanopath's technology and vision at www.nanopath.com

About Nanopath
Nanopath is a women-led company dedicated to improving health equity worldwide, starting with women's health. Nanopath's proprietary molecular diagnostic testing platform takes a radically new approach to how clinicians characterize human health. The company's novel biosensing technology has the potential to enable fast, high-complexity testing at the point-of-care, rather than in centralized laboratories. The company is headquartered in Cambridge, Mass., at The Engine built by MIT, a premier facility for high-potential, tough-tech start-ups. Nanopath is backed by Norwest, the Medtech Convergence Fund, a SV Health Investors Fund, Gingerbread Capital and Alumni Ventures. For more information, visit www.nanopath.com.

SOURCE Nanopath