New Jersey-based health system Hackensack Meridian Health embarked on a cancer research study this week with Israeli diagnostics startup SpotitEarly.
The startup, which entered the U.S. market in May, is developing a test that uses AI and trained dogs to analyze patients’ breath samples, with the goal of detecting cancer at its earliest stages.
SpotitEarly’s test requires patients to breathe into what looks like an N95 mask for three minutes. After the sample is collected, SpotitEarly’s dogs use their snouts to sniff and detect cancer odor signatures found in a patient’s volatile organic compounds, which CEO Shlomi Madar describes as “biological information from the blood in our lungs that travels into the air we exhale.”
If a dog identifies cancer signatures in a sample, it will signal this to the lab by sitting next to it. As the dogs sniff samples in the lab, the company uses its AI platform to track and analyze their physiological and behavioral signals, collecting thousands of data points per second, Madar said.
SpotitEarly, founded in 2020, had already completed a two-year study for its test in Israel before it launched in the U.S. This 1,400-participant study found that the test achieved a 94% accuracy rate for detecting the four most common types of cancer — lung, colorectal, breast and prostate — at various stages.
“This demonstrated the clinical validity of SpotitEarly’s product and its potential to democratize
access to cancer screening at scale,” Madar stated.
By launching a second clinical study, the startup is continuing to validate its platform. Madar noted that Hackensack Meridian patients are now eligible to participate in the study in tandem with their traditional screening.
Two groups of women will be invited to participate in the study: those coming in for their
regular breast cancer screening, either a mammogram or ultrasound, and those scheduled for a
breast biopsy.
“Participants who choose to volunteer will simply breathe into a surgical mask for a few minutes, providing a breath sample alongside their regular screening. The samples will then be sent to our lab, where both trained dogs and our proprietary AI platform will analyze them for breast cancer,” Madar explained.
SpotitEarfly will then compare these findings with the results of patients’ standard
screenings or biopsies.
This trial is a double blind study, meaning that neither the participants nor the researchers know which group each sample came from, ensuring that the results aren’t clouded by any bias, Madar pointed out. The study will run for two years, estimated to conclude in August 2027.
This study is a multi-site trial aiming to enroll about 2,000 participants. Madar said up to 500 of these participants will be women currently undergoing mammograms or biopsies at the Hackensack Meridian site.
“Hackensack Meridian Health has a large and diverse patient population, which creates a strong infrastructure for clinical trials and makes it an ideal partner for the study,” he remarked.
For patients, this research opportunity represents a chance to participate in a novel approach that could make early cancer detection more accessible.
Photo: Anna Rostova, Getty Images
