CancerCheck is a one-of-a-kind early-detection blood test that, for the first time, can extract whole circulating tumour cells (CTCs), enabling a board-certified pathologist to deliver a physician-grade pathology report. The test screens for more than 200 types and subtypes of solid tumour cancers, which make up more than 90 per cent of all cancers, and can detect cancer before symptoms appear, as early as Stage 0, when survival rates are as high as 99 per cent.
"One in three women and one in two men will be diagnosed with cancer in their lifetime," says Sumit Rai, Cancer Check Labs Founder, CEO, and Chairman. "Early screening enabling early detection is the key to surviving cancer."
Other multi-cancer early detection (MCED) screening tests do not isolate CTCs for review by a human, board-certified pathologist; rather, they use biomarkers, circulating-tumour DNA (ctDNA), proteins, or small molecule metabolites to detect if positive cancer signals exist, which can lead to inaccurate, pathologically unconfirmed results. That's what makes CancerCheck different. Using proprietary blood filtration technology, the test extracts and isolates whole CTCs; thereafter, potential CTCs are physically affixed to a slide, enabling application of gold-standard tissue biopsy procedures to the cells. Finally, the prepared slides are submitted for review by an independent, third-party board-certified pathologist to mitigate any possible bias. The result is not a guess; it's a physician-grade pathology report where individual cells are evaluated.
"The CancerCheck process is exactly analogous to what happens in a solid tissue biopsy. The only difference is we're extracting the tissue at a cellular level from a blood sample rather than surgically cutting to procure tissue, which creates, in essence, a whole-body tissue biopsy," explains Jim Ciardella, Cancer Check Labs Chief Commercial Officer.
Recent ctDNA trial results have shown that ctDNA-based detection rates for early-stage cancer can be below 5 per cent. Further, ctDNA false positive rates can be north of 96 per cent, leading to unnecessary invasive procedures, radiation exposure, and diagnostic testing. In stark contrast to ctDNA tests, however, CancerCheck uses a human, board-certified pathologist to effectively evaluate a CTC cellular tissue biopsy. Critically, this intervention meaningfully reduces false positive rates, as actual whole, intact cells are being pathologically evaluated by a human as opposed to incomplete, broken ctDNA fragments being evaluated by black-box machine algorithms. Pathology isn't new, it's not experimental, and it's trusted. In today's medical practice, pathology review remains the trusted gold standard for cancer determination.
Cancer remains the second leading cause of death in the United States, nearly rivalling heart disease. The American Cancer Society projects more than 2.1 million people in the U.S. will be newly diagnosed with cancer this year, and more than 626,000 will die from cancer in 2026.