NEW YORK — After flying under the radar since its founding three years ago, startup Nanopath is emerging out of stealth mode, nabbing an award at the recent AACC Annual Scientific Meeting and Clinical Lab Expo.

Based in Cambridge, Massachusetts, Nanopath's flagship device is a benchtop instrument that employs biosensors that company executives said could help doctors identify the causes of pelvic or gynecological infections within minutes, letting them decide on treatment during a single office visit.

Alison Burklund, Nanopath's cofounder and CTO, said that currently, patients who visit their doctors for such infections today tend to leave with a prescription for antibiotics — without confirmation which pathogen is the cause — or they wait hours to days for test results on samples sent to a diagnostic laboratory. In comparison, internal data suggest her company's technology could bring the total analysis time down to 15 minutes, including sample preparation, by using a nanosensor that can detect genetic signatures of multiple pathogens without the need for amplification.

"In practice, that means we're able to save a significant amount of time relative to something like PCR — or any other assay that requires making many, many copies of DNA or RNA in order to detect them," she said.

Though the platform is still under development, the results so far are promising enough that Nanopath, a spinout of Dartmout College, won the Disruptive Technology Award at last month's AACC conference. The company has generated preliminary data that suggest the device could be used for human papillomavirus genotyping as well as urinary tract infection characterization.

Nanopath executives were reluctant to disclose many details about its device, dubbed the Nanopath Platform, but said it is a toaster-sized, solid-state biosensing platform that uses highly sensitive optical detection to identify the DNA or RNA of bacteria or viruses within samples. Those samples are collected on disposable cartridges about the size of a standard glass microscope slide.

During her presentation at the AACC meeting, Burkland noted that the instrument uses significantly fewer reagents than other similar molecular diagnostic systems currently on the market.

The company's work is supported by private backers as well as a National Science Foundation grant of $256,000, the latter of which was awarded this year toward creation of an integrated point-of-care system for rapid pathogen identification in urinary tract infections.

According to the grant abstract, Nanopath's method applies microfluid methods of cell enrichment with a novel nanostructured substrate for ultrasensitive detection of target nucleic acid sequences. It added that the technology could provide species-level data and genotypic antibiotic resistance data within minutes, and it could be applied to other diseases such as respiratory infections, bloodstream infections, and prosthetic joint infections.

Burklund said the company has multiple patents pending in the US.

One of the three judges for the AACC award, Trevor Hawkins, past director of the Human Genome Project for the US Department of Energy and now an operating advisor at GreyBird Ventures, said Nanopath's technology has the potential to bring about the next wave of diagnostics by delivering a highly multiplexed molecular test with PCR-like sensitivity and specificity at higher speed and lower cost.

"It has the ability to look at a multitude of targets in a very, very simplistic manner because there's really very little sample preparation, there's no amplification, there's no expensive reagents," Hawkins said. "This is a game changer if everything works out the way that we hope.

"We looked at this and said, 'This could transform this space if it really works out,'" he said.

Nanopath CEO Amogha Tadimety, who cofounded the company in 2019 with Burklund, said Nanopath is targeting the range of pelvic and gynecologic conditions for which a woman might seek outpatient care and that today involve processing a patient sample off-site. The company's machines could someday be installed across a range of outpatient providers including outpatient clinics, primary care physicians' offices, gynecologists' offices, and student health centers.

"We're trying to be the go-to system to address the entire spectrum of disease-causing conditions in the women's health context," Burkland said.

Tadimety and Burklund envision physicians will collect samples on cartridges that are specific to each patient's indication, and the platform would test for multiple pathogens known to cause that target condition. Nanopath's current sensing substrate can be used to simultaneously detect up to 12 genetic targets, but Burkland said the cartridges could be fitted with additional sensors and, in theory, simultaneously test for 20 or 30 genetic targets — up from a handful detected with a multiplex PCR assay.

Burklund said that because the company is still in its research and development phase, it is not sharing its disease indication pipeline with the public.

Gregory Tsongalis, director of clinical genomics and advanced technology at Dartmouth-Hitchcock Health and advisor to Nanopath, said he sees the potential to miniaturize the technology, place it at patient bedsides or in clinics, and improve access to molecular diagnostics. He said he has seen promising preliminary data from proof-of-principle studies on infectious disease and cancer targets, but how soon those benefits will emerge depends on how quickly Nanopath can commercialize the product.

"I've been involved in a couple of the studies that they've done and, so far, the data looks incredibly promising, which is really exciting in the diagnostic space," he said.

Hawkins said that, from the AACC judges' perspective, Nanopath's technology showed promise in many areas, including solid intellectual property strategy, good understanding of its market, robust technology, a working prototype, test results that demonstrate key advancements, an understanding of who would buy the products and how they would apply it, and a start toward regulatory approval through the company's submission to the US Food and Drug Administration for breakthrough device designation. He also said Nanopath has the admirable qualifications of being a women-founded, women-led, and women's health-focused company.

Burkland said at AACC that pending FDA breakthrough device designation, Nanopath also plans to bring its device through the FDA's 510(k) de novo clearance pathway. She added that the company has no price estimates for its products but is committed to giving broad access to the technology.

Tadimety said Nanopath is pre-revenue and open to development partnerships.

Hawkins expects the Disruptive Technology Award will bring Nanopath attention and help the company find a manufacturing partner. He said Nanopath, along with the other finalists and semifinalists for the Disruptive Technology Award, presented impressive technologies that show the biotech industry has a strong bench of up-and-coming companies. Nanopath now has the critical job of gaining a manufacturing partner who can build the devices and cartridges.

"The CEO gave a fantastic presentation, they're energetic, they want to win, and winning this award made a huge difference for them — and will make a huge difference for them in the next 12 months as they get a lot of press and a lot of interest in what this technology could do," Hawkins said.

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