Moncton-based Breathe BioMedical has expanded a clinical study of its breast cancer detection device after a clinical study found an 88 percent success rate in detecting breast cancer.

The company issued a press release recently saying that Pittsburgh’s Weinstein Imaging Associates has become the fourth site in its multi-centre observational study aimed at advancing a breath test designed to detect breast cancer in women with dense breast tissue. The technology is being developed as a supplement to mammography, which is less effective in women with dense breasts.

Breathe BioMedical, originally founded in 2005 as Picomole, is best known for developing a device that functions somewhat like a breathalyzer for cancer detection. Patients provide a breath sample that is analyzed for chemical compounds associated with disease.

“It is well understood that mammography alone is insufficient in detecting breast cancer for women with dense breast tissue, creating the need for accurate, accessible and cost-effective adjunctive detection tools,” said CEO Bill Dawes in a statement.

According to the company, a proof-of-concept study found the technology achieved 88.2 per cent accuracy in distinguishing between women with early-stage breast cancer and those without the disease. The study reported sensitivity of 92.9 per cent and specificity of 80 per cent, regardless of breast tissue density.

The company is now conducting a larger clinical trial involving major research institutions, including the Mayo Clinic, George Washington University and Duke University. The study, launched in February 2025, is expected to enroll as many as 800 participants across U.S. and Canadian sites.

Weinstein Imaging was selected in part because of its same-day workflow for women undergoing mammograms and biopsies. The site will collect breath samples from patients while researchers compare breath profiles of women with and without breast cancer.

Dense breast tissue remains a significant challenge in breast cancer screening. About half of the 70 million U.S. women eligible for breast cancer screening have dense breasts, according to Breathe BioMedical. Dense tissue can make tumours harder to detect on mammograms because both appear white on imaging scans.

The company's technology focuses on volatile organic compounds released by the body's metabolic processes. Breathe says cancer-related changes can alter these compounds, creating detectable patterns in exhaled breath. Samples collected through the company's SohnoXB breath sampler are analyzed in its Moncton laboratory using infrared laser technology and machine-learning software.

Breathe BioMedical said it plans to begin enrolling patients at sites in New Brunswick, Nova Scotia and Ontario later this summer. The company is also working with the New Brunswick government on commercialization plans in its home province.

While its immediate focus is breast cancer detection, Breathe says its breath-analysis platform could eventually be adapted for other cancers and diseases.