SpotitEarly has entered into a strategic research partnership with Fox Chase Cancer Center to support the clinical validation of its breath-based cancer detection technology, as the company continues to expand its presence in the USA ahead of commercialisation.

The collaboration includes a multi-year, investigator-initiated clinical trial led by Fox Chase Cancer Center to evaluate the performance of SpotitEarly’s exhaled-breath test in patients undergoing standard-of-care assessment for suspected lung cancer. Fox Chase Cancer Center is part of Temple Health and includes the Institute for Cancer Research and the American Oncologic Hospital.

Under the terms of the master research collaboration agreement, Fox Chase will oversee the clinical study, which will assess the test in a real-world clinical setting. SpotitEarly said the partnership model is intended to align long-term incentives between the organisations and accelerate clinical translation, with the potential to expand the framework to additional cancer indications beyond lung cancer.

The trial will evaluate SpotitEarly’s proprietary breath-based screening approach, which is designed to identify cancer-associated odour signatures. The company’s platform combines artificial intelligence and machine learning with trained canine scent detection to analyse breath samples collected non-invasively from patients.

Sangeeta Bardhan Cook, chief innovation officer at Fox Chase Cancer Center, said: “At Fox Chase, we are committed to pushing the boundaries of cancer research through bold and collaborative partnerships. SpotitEarly brings an unconventional yet scientifically promising approach to early detection, and we see tremendous potential in their innovative product and technology when combined with our robust clinical expertise.”

She added: “Together, we will open new doors to earlier diagnoses and, ultimately, better outcomes for patients.”

The Fox Chase collaboration follows a series of recent partnerships announced by SpotitEarly in the USA. In July, the company reported a partnership with Hackensack Meridian Health, New Jersey’s largest health network, alongside plans for joint clinical trials. SpotitEarly entered the US market in May and has since focused on establishing clinical and research collaborations to support validation of its technology.

Shlomi Madar, ceo of SpotitEarly, said the Fox Chase partnership represents a further step in the company’s US expansion strategy. “Working with Fox Chase Cancer Center was a natural next step for our organization as we continue to grow our footprint in the states,” he said.

He added: “As a leader in cancer research, their team will provide us with access to a vast network of physicians and resources to collaborate on groundbreaking clinical trials and treatments, moving forward our mission of increasing accessibility to early cancer detection technology for millions.”

SpotitEarly’s technology is built on its proprietary LUCID bio-AI hybrid platform, which integrates machine learning algorithms with sensor-based monitoring of trained canines. The platform continuously tracks canine behavioural and physiological signals during scent detection, translating these signals into a standardised and repeatable analytical output. According to the company, this approach is designed to enable scalable laboratory analysis of breath samples.

The company has previously reported data from a completed prospective, double-blind clinical study involving more than 1,300 participants. In that study, the platform demonstrated overall sensitivity of approximately 94% across four common cancers, with reported performance in early-stage disease. SpotitEarly’s test uses a face mask-based breath collection method and is intended to support earlier detection, when treatment options are typically more effective.

Subject to regulatory approval, SpotitEarly aims to broaden access to non-invasive cancer screening across multiple cancer types. The company said partnerships with academic and clinical institutions will remain central to its strategy as it moves toward commercialisation.