With a major funding round in its sights this year, Moncton-based medtech company Picomole is aiming to have a product on the market in 2024 that can detect lung cancer from a single breath sample.

The technology has been in development for about a decade, and the company got a major boost from a $6.5 million funding round in 2019. Now the 22-member team is developing the product in preparation for a launch in the New England market in about three years.

The vision is to use the device for the early detection of several forms of cancer and other diseases, but the first mission is to use it for lung cancer – a disease that kills 154,000 people each year in the U.S. alone. The goal is to improve the early detection, because the earlier cancer is detected the greater the chances of survival.

“Lung cancer is absolutely our focus right now,” said CEO Stephen Graham in an interview. “That’s the first product we want to bring to market – a lung cancer screening product and our next most important is breast cancer. . . . If we are successful, we will look to increase the breadth of the research into other diseases.”

The device is made up of three components.

First, there is the sampler, which resembles a breathalyser that police use to test the sobriety of drivers. Ideally, it will be located in a clinic or pharmacy, and patients will breathe into it to collect a quick sample. Picomole expects to list the sampler (which is the part of the system that actually comes into contact with the patient) from the Food and Drug Administration in the U.S. and Health Canada this summer, which means it could be sold to laboratories.

Second, there is the spectrometer, which analyzes the samples. In Picomole's original concept, a small spectrometer would have been attached to the sampler. But the team has opted to develop a larger spectrometer, with three times the resolution, that will be placed in a centralized lab.The collected samples will be sent to the lab to be analyzed on the spectrometer, with a two-day turnaround.

Graham said the regulatory process for the spectrometer will take a bit longer and be more complex than for the sampler.

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Finally, the team is working with Erik Scheme, the Director of the Health Technologies Lab at the University of New Brunswick, to develop the machine learning component of the product. They are now developing the models, and the outcomes will improve as they get more data to use with the algorithms.  

In developing this product, Graham is quick to acknowledge the financial support the company has received from such organizations as the Atlantic Canada Opportunities Agency, IRAP, the New Brunswick Innovation Foundation and others, and added that the New Brunswick Small Business Investor Tax Credit was an “integral” tool in raising capital.

While working on a proof of concept study for its breast cancer application at Saint John Regional Hospital, Picomole is also conducting research elsewhere. It is working with McMaster University in Hamilton, Ont., on using the device for a COVID test – research that is funded by the Department of National Defence. Picomole is also conducting trials at University of California at Irvine to detect early-stage breast cancer.

Graham said the company has increased its international network by attending Canadian Technology Accelerators in Boston and other U.S. cities. It hopes to enroll in the CTA planned for Germany.

Graham envisions launching the product in the Boston area, where Picomole already has two employees. After the 2024 launch, the company plans a steady expansion in the U.S. over three to four years to demonstrate the company’s ability to scale. 

“We’re looking at 2024,” said Graham. “We anticipate rolling it out in one area in the U.S. and the most logical area is New England. Each year, we’d like to expand to another area of the market. We want to start modestly and then expand.”