Startup SpotitEarly is pioneering an innovative early cancer screening test based on breath samples and powered by artificial intelligence and the strong scent detection of trained dogs.
SpotitEarly launched in the U.S. market in May, armed with $20 million in funding. The company, initially founded in Israel, plans to roll out its breath-based, at-home early detection test in the U.S. next year. It's preparing for an FDA pre-submission as part of a phased regulatory strategy, executives said.
New Jersey-based Hackensack Meridian Health is teaming up with the startup to validate its non-invasive approach to early cancer detection.
As part of the research collaboration, SpotitEarly will work with the Hennessy Institute for Cancer Prevention and Applied Molecular Medicine, part of the Hackensack Meridian John Theurer Cancer Center, and Hackensack University Medical Center.
The clinical research expertise of the Hennessy Institute and Hackensack Meridian Health will be critical in validating SpotitEarly’s technology, the organizations said.
"The fact that nearly two-thirds of cancer diagnoses lack a dedicated screening method is an unacceptable gap in modern medicine. To address this, we are partnering with SpotitEarly to advance their innovative breath test technology. This initiative is central to our mission to pioneer proactive prevention and fundamentally transform the future of cancer care," said Andre Goy, M.D., physician-in-chief and vice president of Oncology at Hackensack Meridian John Theurer Cancer Center.
"Partnering with SpotitEarly on this innovative breath test technology offers a potentially groundbreaking approach to screening and aligns perfectly with our mission to transform cancer care through proactive prevention," Goy said.
The research collaboration will begin with the launch of the PINK Study, a 2,000-participant multi-center, double-blind observational study focused on breast cancer detection, led by breast cancer and cancer genetics specialist Elias Obeid, M.D., the medical director of the Hennessy Institute. The trial will enroll up to 500 women currently undergoing mammograms or biopsies for breast cancer detection at Hackensack Meridian.
"The endpoint is to show a high level of sensitivity and specificity for the early detection of breast cancer," Shlomi Madar, CEO of SpotitEarly, said.
The initial focus of the research collaboration will be on breast cancer detection, but there are future plans to broaden the research to include other cancer types, such as lung and prostate.
SpotitEarly's vision is to develop a multi-cancer test using its unique approach of combining AI and dogs' noses, Madar noted.
The collaboration also builds on the company’s initial clinical trial results that showed its cancer detection technology achieved a 94% accuracy rate in a study involving 1,400 individuals. That study, published in Nature’s Scientific Reports, was conducted in partnership with three major healthcare institutions in Israel.
Madar also asserts that SpotitEarly's detection test has a high level of accuracy in detecting multiple cancers in their early stages.
According to the American Cancer Society, when breast cancer is detected early, and is in the localized stage, the five-year relative survival rate is 99%.
"If we can combine this capability of detecting cancers at stage 1 with the reach of our partners at Hackensack, I think this would be a very interesting study," Madar said.
How SpotitEarly's early detection test works
SpotitEarly was founded in 2020 by four friends. The founding team combines skills across clinical research, technology and laboratory operations, and includes a former K9 unit commander known for his strategic acumen, according to the company's website.
Madar is a healthcare and biotech leader with more than 15 years of experience and a Ph.D. in Cancer Research from the Weizmann Institute of Science.
As a canine diagnostics company, the startup's vision is to offer a simple at-home breath test for the four most common types of cancer—breast, colorectal, prostate and lung—to address the urgent need for advancements in early detection and prevention of cancer.
It also marks an approach to early cancer detection that is easy for individuals to use from home and is more affordable, Madar noted.
Human breath contains over 1,000 volatile organic compounds or VOCs. Science has shown that VOCs represent rich sources of biomarkers associated with metabolic processes and diseases in the body, each identified by a significant odor signature, including cancer, according to the company.
SpotitEarly harnesses the science of scent to detect cancerous VOCs in exhaled breath samples.
Individuals who order a test simply wear a breath collection mask designed for at-home medical testing and breathe naturally for three minutes, according to the company. Individuals then send the mask to the SpotitEarly CLIA-registered lab.
That's where the AI and the dogs come in.
The olfactory system of dogs is sophisticated and incredibly powerful, the extent that it can detect one part per trillion. With around 250 million to 300 million receptors, a dog's sense of smell is estimated to be between 10,000 to 100,000 times more sensitive than humans. Also, about 30% of a canine’s brain function has to do with olfaction. That's why dogs are trained for highly skilled tasks like tracking scents, detecting drugs or explosives, and, of course, identifying certain diseases in humans, SpotitEarly executives say.
"Typically, the question that I get is, why not use artificial instruments? The answer is that we've been trying to do that for three decades, and it's just not sensitive enough," Madar said. "The sensitivity of the dogs is around part per trillion, some say even more, which is already three orders of magnitude greater than any electronic nose, which is limited with the amount of sensors that we have. They have superior hardware built into their nature."
He added, "On top of that, they have something called the olfactory bulb. This is a small organ located in the frontal lobe of the dogs, and that really helps them process a lot of information, sends the information in real time and deciphers between the signal and the noise. The starting point, already, for just sensing the disease, before we come in with technology and artificial intelligence, is higher than what we're seeing with any artificial sensors."
SpotitEarly developed its LUCID, a bio-AI hybrid platform that combines advanced AI biochemistry and machine learning algorithms. In the company's lab, its LUCID system tracks hundreds of live physiological and behavioral data points every second and interprets the canine's reaction to breath samples, along with exclusive algorithms that then determine the likelihood of cancer's presence
Trained dogs—SpotitEarly is currently using beagles—sniff the breath samples in the lab and LUCID tracks and analyzes their physiological and behavioral signals, collecting thousands of data points per second, Madar said.
The dogs are trained to mark a sample as positive for cancer through a distinct behavioral cue—sitting beside the sample immediately after sniffing. Marking the sample as negative is done by continuing to the next sample without sitting. This action lasts less than a second.
Rather than relying on human interpretation of the dogs' gestures, SpotitEarly combines hardware and software to analyze the dogs' signals. The dogs wear vests that have accelerometers and heart rate sensors to measure their physiological signs, Madar said.
"We also have two sets of cameras, one on top of the lab and then inside the sniffing ports that can look at their facial gestures and this information is fed into the LUCID system.
"It can interpret the dogs without any kind of human interference," Madar said.
LUCID's exclusive algorithms can determine the likelihood of cancer's presence in each sample, resulting in a highly accurate cancer screening test. Individuals are given their test results within days. If a risk of cancer is detected, the patient will be referred for further diagnostic procedures.
One lab with 18 to 20 dogs can run 1 million tests a year. SpotitEarly plans to open a lab in the U.S. in the next 18 months, Madar said.
The lab's bio-AI hybrid platform integrates a fusion sensoric lab, AI algorithms, VOC delivery methods and big data, and was designed to be easily replicated worldwide.
"We automated and we mechanized most of the process to the level that it's very reproducible, repeatable and reliable," he said.
Madar stresses that the dogs are not lab animals—they are essential members of SpotitEarly's workforce.
"The dogs are part of the team, so they're amazing. We tried a few breeds. We ended up working with beagles. They're being treated like part of the team, so they have plenty of room to play. They work two to four hours a day," he said. "All of us, and I think it's prerequisite to join the company, are dog lovers. For me, on a personal level, cancer has been a passion of mine. Dogs have been a part of my life. I really believe in this combination. Seeing the results, seeing the evidence, for me, was something that clicked immediately."
The pups are carefully trained using positive reinforcement and are deeply bonded with their trainers. The training program typically takes four to six months. Currently, the dogs live in a kibbutz in Israel where SpotitEarly's labs are located, close to nature.
SpotitEarly's at-home early cancer detection test will help fill an unmet need to increase cancer screening rates, Madar said.
Only 14% of cancers in the United States are diagnosed through a recommended screening protocol, research from the University of Chicago.
"This number is far too low, especially with how much we know about the life-saving potential of early detection,” Madar said.
“Our goal is to help close this gap by exploring and developing innovative screening solutions. Driven by a shared mission to transform our healthcare system from a reactive to a proactive one, this partnership with Hackensack Meridian Health marks a pivotal first step in making our technology available in the U.S.," he said.
At-home screening is more accessible, he noted. "Not everybody can go to the clinic. Think about the U.S., how big it is, in rural areas, that's certainly something that is a big problem," he said. "This at-home screening is non-invasive, which I cannot say about all of the traditional screening tests, think about colonoscopy or mammograms, low-dose CT for lung cancer. These are uncomfortable, some somewhat invasive, and not everybody would end up taking it."
The company is using its $20.3 million funding round to build out the infrastructure for commercializing the product and completing additional clinical studies. SpotitEarly's investors include Hanaco VC, Menomedin VC, Jeff Swartz (former CEO of Timberland) and Avishai Abrahami (CEO of Wix.com). The company has also been awarded several grants, most notably from the BIRD Foundation.
SpotitEarly also aims to run a pilot program in the U.S. by the end of 2026.