The molecular diagnostic system can identify complicated UTI pathogens and antibiotic resistance markers at the point-of-care in approximately 15 minutes.
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Nanopath’s molecular diagnostic platform for rapid detection of complicated urinary tract infections (UTIs), clearing an accelerated pathway for the Cambridge, Massachusetts-based company’s commercial launch.
The designation recognizes the platform’s potential to deliver actionable molecular results within a single office visit for patients with suspected or at-risk complicated UTIs. The system can simultaneously identify cUTI-causing pathogens and key antibiotic resistance markers at the point-of-care in approximately 15 minutes from a urine sample.
“Receiving Breakthrough Device designation is an exceptional recognition of Nanopath’s technology and its potential to transform how UTIs are diagnosed,” says Amogha Tadimety, PhD, co-founder and co-chief executive officer of Nanopath, in a release. “It is incredibly rare for a diagnostic test—particularly in microbiology and women’s health—to receive this distinction.”
Addressing a Multi-Billion Dollar Market
Complicated UTIs represent one of the most common infections worldwide. Current culture-based, laboratory-scale tests can take several days to return results, while Nanopath’s cartridge-reader solution is designed to deliver diagnostic insights during an office visit.
The molecular approach differs significantly from existing testing methods, according to a company release, which notes that no current test can provide molecular-level insight for complicated UTIs during a patient encounter.
“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,” says Edward Evantash, MD, chief medical officer of Nanopath, in a release.
Regulatory Pathway and Commercial Timeline
The FDA’s Breakthrough Devices Program accelerates development, assessment, and review 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 commercialization.
The rapid testing capability could enable clinicians to initiate appropriate therapy faster and reduce unnecessary or ineffective antibiotic use, addressing growing concerns about antimicrobial resistance.
“For too long, patients have waited days or even weeks for critical test results,” says Jeff Crowe, senior managing partner at Norwest, in a release. “Nanopath is transforming diagnosis and care delivery by providing faster, more reliable results that clinicians can act on.”
Company Expansion
Last month, Nanopath announced the expansion of its leadership team with five executives hired to support scientific and commercialization growth. The women-led company is headquartered at The Engine built by MIT and is backed by Norwest, the Medtech Convergence Fund, an SV Health Investors Fund, Gingerbread Capital, and Alumni Ventures.
The company’s proprietary molecular diagnostic testing platform represents what it calls a new approach to clinical characterization, with potential to enable high-complexity testing at the point of care rather than in centralized laboratories.
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