An Israeli startup company, SpotitEarly, claims to have developed a breath test that can detect cancer with a 92.8% success rate in identifying the four most common types of cancer - breast, lung, colorectal, and prostate.
The results of their mid-term clinical study, which began around a year and a half ago, show a high level of sensitivity for the early stages of the disease and a low false identification percentage of 7%.
This new test could potentially revolutionize the first line of cancer screening tests.
The Base of the Test
The test is based on artificial intelligence technology that deciphers the physical and behavioral signals of biomedical sniffer dogs, which are part of the company's laboratory team. The dogs have been trained to detect the unique "cancer odor signature" of volatile organic compounds (VOCs) secreted by cancerous tumors at an early stage of their development.
SpotitEarly's technology tracks and monitors hundreds of channels of information produced by the dogs in real-time as they sniff the samples and combine them with medical data to produce an accurate and non-invasive screening test for several types of cancer.
The test is easy to perform and can be done from home, a survey institute, or a clinic. Participants simply wear a designated face mask and blow into it for five minutes. The mask is then sent back to the company's laboratory for testing, and the result is reported to the doctor and patient within a few days.
The company intends to reach a sample rate of one million screening tests per year, and the cost of the product is about 25% less than other competing screening products.
The Research
SpotitEarly's clinical research is being led by Professor Nadir Arber and conducted in collaboration with two Israeli medical centers and MIDGAM, a national database for biological samples. The mid-term results were based on samples of 575 participants, including verified cancer patients and a control group without cancer, collected at the hospitals and tested at SpotitEarly's laboratory under blinded conditions.
The test was able to identify 92.8% of the sick participants, with a false positive rate of 6.98%. The level of sensitivity remained high even in the early stages of the disease when symptoms were usually not present and were particularly high for breast and lung cancer.
Dr. Yifat Zivoni, VP of Clinical Laboratory at SpotitEarly, says, "The results of the research so far are groundbreaking. The test developed by SpotitEarly can set a revolution in the first line of cancer screening tests, should the company maintain the results by the end of the study.
Unlike other screening tests that have recently come into use, the high specificity of the new test does not come at the expense of sensitivity. Hence it is applicable for the wide distribution of the product. This, combined with ease of use, will lead to a significant increase in the application of early cancer screening tests for large segments of the population. The result will be the saving of human lives and easing the burden of cancer on the healthcare system."
SpotitEarly is continuing its research to include 2,000 participants in total and will approach the regulatory authorities to introduce the tests into widespread use after the study is concluded. The company has set a financial goal for when the test is commercialized in Israel and plans to donate a portion of the proceeds to the Israel Cancer Association as part of an official collaboration with the society.
The breath test developed by SpotitEarly shows promising results in early cancer detection and could potentially revolutionize the first line of cancer screening tests. The test is non-invasive, easy to perform, cost-effective, and has a high level of sensitivity even in the early stages of the disease.