In a remarkable convergence of nature’s finest detection capabilities and cutting-edge artificial intelligence, the Israeli startup SpotitEarly launched in the U.S. market, aiming to fundamentally revolutionize the landscape of cancer diagnostics. The company is pioneering an innovative, breath-based test designed for the early detection of multiple cancer types, a groundbreaking method that leverages the extraordinary olfactory sense of highly trained dogs and proprietary AI technology. This unique bio-hybrid approach is poised to address a significant accessibility gap in current cancer screening protocols.
The ingenious test requires patients to simply breathe into a collection device, which resembles an N95 mask, for a brief three minutes. Once collected, the breath sample, containing a wealth of volatile organic compounds, is shipped to a specialized SpotitEarly laboratory. Here, the company’s specially trained canines utilize their powerful snouts to sniff out and identify the faint, yet distinct, odor signatures of cancer. SpotitEarly CEO Shlomi Madar described these compounds as “biological information from the blood in our lungs that travels into the air we exhale.” The integration of man’s best friend into this high-tech diagnostic process is a testament to the unparalleled sensitivity of the canine nose, surpassing that of any current electronic detection device.
The operational brilliance of the system lies in how the canines’ biological capabilities are interpreted by technology. If a dog successfully identifies cancer signatures in a sample, it immediately signals this detection to the lab by sitting next to it, as Madar stated. Simultaneously, as the dogs meticulously sniff samples in the lab, the company’s sophisticated AI platform diligently tracks and analyzes their physiological and behavioral signals, accumulating thousands of data points per second, Madar added. This AI layer serves to eliminate potential human error in reading the animal’s cue, transforming the innate talent of the dog into quantifiable, clinical data.
SpotitEarly, which was originally founded in 2020, has already solidified the clinical promise of its technology. The company successfully completed a two-year study for its test in Israel, which involved 1,400 participants. This crucial study demonstrated that the breath test achieved an impressive 94% accuracy rate in detecting cancer. Building upon this success, the company is actively working with the Israeli Ministry of Health to secure regulatory approval and facilitate future market entry. Concurrently, the startup is expanding its clinical validation efforts by running a new study in the U.S. that specifically targets breast cancer detection. For this latest trial, the startup is strategically enrolling participants who are already scheduled for routine screenings. Madar noted that due to the test’s user-friendly and non-invasive nature, SpotitEarly has observed high acceptance rates among the participants in this trial, signaling strong patient preference for such a comfortable alternative.
The U.S. launch has also opened up the company’s Series A funding round to U.S. investors, following an initial seed funding total of $20.3 million. Looking ahead, the company intends to begin making its cancer tests commercially available, sending them directly to consumers via a physician network, starting in 2026. This direct-to-consumer model is a critical step in democratizing early detection. The user experience is designed to be seamless: users will initiate the process by ordering the test straight to their door via a physician. They will then self-collect their breath sample, package the mask, and ship it off to a SpotitEarly lab, Madar explained.
In terms of market positioning and target audience, Madar views SpotitEarly’s ideal customer as an individual motivated to proactively manage their health. He points out a glaring systemic issue in the U.S. healthcare model: “Unfortunately, traditional screening methods like mammograms and colonoscopies aren’t typically covered by insurance until around the age of 45, but cancer rates are climbing in younger populations, underserving critical populations. There is growing momentum to shift to a preventative healthcare model, but too often, the system still tends to prioritize reactive care over early detection,” Madar remarked. He notes that existing direct-to-consumer screening options, such as fecal tests or whole-body MRI scans, are often uncomfortable and financially exclusionary for the majority of the population.
Using Prenuvo’s MRI as a salient example, Madar highlighted the economic barrier to entry for many Americans. He declared, “This scan costs patients around $2,500, and most Americans can’t cover a $1,000 emergency expense, so there is a clear disconnect between trying to catch cancer and other diseases early and the accessibility of this product.” Furthermore, even competing blood tests face significant challenges. Grail’s Galleri test, for instance, costs nearly $1,000, yet Madar stated that it performs poorly in detecting cancer at its earliest stages, a crucial point for improving patient outcomes.
SpotitEarly aims to offer a dramatically more accessible solution, with the test slated to cost just $250 for screening a single cancer type and $500 for all four common cancers it screens for: breast, colorectal, prostate, and lung. This affordability, combined with the non-invasive process, is its primary competitive advantage. Madar remarked, “SpotitEarly differentiates itself by offering a non-invasive, comfortable and accessible alternative that you can do from anywhere, no matter how close you are to a hospital or medical center — and you aren’t boxing up your feces and other bodily fluids.” Establishing a robust presence in the U.S. will ultimately help the startup further its core mission of reducing late-stage cancer diagnoses and will generate new opportunities for essential collaborations with leading research institutions. The remarkable partnership between sophisticated AI and the dog’s astonishing sense of smell promises a brighter, more proactive future for cancer screening.
(Hero image credit: SpotitEarly)
