MDx Platform Provides 15-Minute Results Without Nucleic Acid Amplification

A novel approach to molecular diagnostic testing harnesses advances in bioengineering and nanotechnology to accurately identify and characterize a variety of pathogens within minutes, compared to existing gold-standard diagnostics that take days to return results. The technology can simultaneously characterize multiple pathogens with one test, leading to faster, more precise diagnosis and treatment.

Nanopath’s (Cambridge, MA, USA) proprietary biosensing technology utilizes ultrasensitive optical detection to identify DNAs and RNAs, without the need for nucleic acid amplification. This amplification-free approach minimizes reagents, lowers costs and reduces user steps that are ubiquitous across molecular diagnostics. Nanopath's platform will require minimal training to operate, making high-complexity molecular diagnostics testing accessible at the point-of-care. Nanopath's technology has the potential to simultaneously test for multiple viral, bacterial and fungal pathogens, based on presenting symptoms, and reduce delivery of test results from days to just 15 minutes.

Nanopath’s officials believe that the platform should be a “go-to” system for routine women’s health screening at the point of care because it enables high-complexity tests and allows physicians and clinics to get testing revenue. To date, the company has generated preliminary data in two clinical indications: human papillomavirus genotyping and urinary tract infection characterization. In late July, Nanopath was named winner of the 2022 AACC Disruptive Technology Award, which recognizes innovative testing technology solutions that improve patient care through diagnostic performance or access to high-quality testing.

"Nanopath's mission is deeply rooted in improving women's health and even more broadly, health equity for all. We envision Nanopath's technology as the go-to platform for routine women's health screening, allowing for clinically actionable diagnosis within a single office visit," said Amogha Tadimety, Ph.D., co-founder and CEO of Nanopath.

"What we are building has the potential to holistically improve patient care by circumventing existing complex, expensive and time-consuming workflows, while simultaneously providing more granular health information," said Alison Burklund, Ph.D., co-founder and CTO of Nanopath. "We started in the women's health space because of the deep unmet need, and our desire as founders to bring a first-in-class diagnostic platform to a population that has been consistently overlooked. That said, our technology has the potential to be valuable in any situation where DNA or RNA detection is useful, including respiratory disease diagnosis, characterization of genetic risk factors, and even biosecurity surveillance and environmental monitoring."

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