Moncton, New Brunswick and Cambridge, Massachusetts — May 5, 2026 — Leads & Copy — Breathe BioMedical announced the addition of Weinstein Imaging Associates in Pittsburgh, Pennsylvania, as a new clinical site in its multi-center observational collection protocol study. The study aims to advance the development of its breath test for the early detection of breast cancer in women with dense breasts, as an adjunct to mammography.
Weinstein Imaging Associates, with Dr. Danielle Sharek as Site Investigator, will collect breath samples from participants at its Pittsburgh facility. Researchers will compare the breath profiles of women with and without breast cancer to identify disease-specific patterns for breast cancer detection.
The focused same-day workflow at Weinstein Imaging Associates for women undergoing mammography and requiring biopsy makes it a valuable addition to the study. This clinical setting provides a unique opportunity to demonstrate that Breathe BioMedical’s study visit and breath sample collection can be seamlessly accommodated within this type of accelerated care pathway. It also ensures broader representation of women in the study’s target population – those with dense breast tissue who are at elevated risk and actively navigating the diagnostic process.
Weinstein Imaging stated that early detection of breast cancer decreases morbidity and mortality. The company also stated that its goal is to detect breast cancers at an early stage and is excited to take part in Breathe BioMedical’s research, as it wants to explore any possibility that may improve early detection and advance the care of its patients.
Preliminary analysis of Breathe BioMedical’s breast cancer proof-of-concept study found 88.2% accuracy (92.9% sensitivity, 80.0% specificity) in differentiating between the breath signatures of women with early-stage breast cancer compared to those without breast cancer, irrespective of breast density. This study compares the breath profiles of women from a diverse patient population across a range of demographics and geographic areas to further develop Breathe BioMedical’s technology and enhance its machine learning algorithm’s capability to differentiate between the breath profiles of women with breast cancer and those without breast cancer. The study will assess sensitivity, specificity, false negative rate and false positive rate.
According to Bill Dawes, CEO of Breathe BioMedical, 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. He also stated that Breathe BioMedical is pleased to welcome Weinstein Imaging Associates in Pittsburgh as a valued clinical partner in its growing multi-center study and that their expertise in breast imaging makes them an ideal collaborator as they build a diverse and robust dataset to advance their breath-based detection technology.
Approximately 50% of the 70 million women in the U.S. that are eligible for breast cancer screening have dense breast tissue, making them 4 to 5 times more likely to develop breast cancer than women without dense breast tissue. Although mammography is the current gold standard for breast cancer screening, the interpretation of a mammogram can be especially challenging with dense breast tissue, because both tumors and dense breast tissue appear white on a mammogram. Evidence suggests that mammography alone fails to detect breast cancer in 30%-50% of women with dense breast tissue.
Exhaled breath contains chemicals called Volatile Organic Compounds (VOCs). These VOCs are a byproduct of metabolism, travel through the blood stream, and are excreted in breath during alveolar gas exchange in the lungs. These compounds and changes in them can provide insights about the state of an individual’s health, environmental exposure, and about how the body reacts to changes that may be a result of disease.
Breathe BioMedical has developed a Breath Sampler that allows individuals to provide a breath sample which can then be analyzed for combinations of biomarkers which may be indicative of disease. The sampler collects alveolar breath stored on industry standard sorbent tubes which are transported to our central laboratory. The sample is then processed using our proprietary Spectrometer, with detection capability to parts per trillion levels, producing a spectrographic data set. The Machine Learning Algorithms (MLA) are applied to the spectrographic data set to identify disease biomarkers and patterns that are associated with breast cancer.
Breathe BioMedical is developing a breath analytics platform to enable the early detection of disease. The company’s breath analytics technology collects, processes, and analyzes breath samples to identify biomarker patterns associated with specific diseases. Breathe BioMedical is focused first on developing a breath test for breast cancer detection for women with dense breast tissue, as an adjunct to mammography, with the goal of increasing the number of breast cancer cases identified at the earliest stages. Breathe BioMedical is headquartered in Moncton, New Brunswick, with a US subsidiary in Cambridge, Massachusetts.
Weinstein Imaging is an imaging center located in Pittsburgh, Pennsylvania with three board certified radiologists. With over 40 years of service, Weinstein Imaging has built a reputation for excellence in women’s health. The practice operates across three prime locations in the Pittsburgh area, offering comprehensive imaging services including mammography, ultrasound, bone densitometry, and same day results. Weinstein Imaging has participated in research projects to improve imaging equipment and to advance breast cancer research.
Source: Breathe BioMedical
