New multi-cancer early detection screenings can save lives

By Stephen Ezell

This is a lightly edited excerpt of testimony recently provided to the U.S. House’s Energy and Commerce Health subcommittee hearing "Examining Policies to Enhance Seniors’ Access to Breakthrough Medical Technologies."

Cancer will not be beaten without hard-fought biomedical innovation, both in the development of technologies to screen for cancers and therapeutics to treat them. However, only five types of cancer — breast, cervical, colorectal, prostate and “high-risk” lung (collectively accounting for about 40 percent of U.S. cancer incidence) — currently have guideline-recommended screening options available today. This means that the vast majority of cancers — including blood, head and neck, pancreatic, ovarian and liver cancers — have no guideline-recommended screening tests available. 

Seventy percent of U.S. cancer deaths occur from cancers for which there are no guideline-recommended screening alternatives. As such, the vast majority of cancers are unfortunately found only when patients arrive at doctors’ offices, manifesting physical symptoms. Only 14 percent of cancers are found through the guideline-approved screenings for the five types of aforementioned cancers.

Early detection through advanced technology

Fortunately, a revolutionary new approach called multi-cancer early detection (MCED) —powered by a suite of advanced technologies including artificial intelligence, machine learning and gene sequencing — is emerging, heralding the opportunity to transform cancer screening, potentially detecting many more cancers much earlier, saving lives and potentially generating significant economic benefits.  

MCED technologies hold the potential to detect, from a simple blood draw, as many as 50 different types of cancers with a very high rate of accuracy, a low false positive rate and the ability to trace the detected cancer to its likely tissue of origin with a high degree of confidence. As all human cells shed nucleic acid fragments into the bloodstream, the technology works by detecting circulating tumor DNA (ctDNA) in the bloodstream as a biomarker for cancer detection. Further, the technology can link detected cancers to their tissue of origin by analyzing methylation patterns. Methylation refers to an essential step in the process of cellular differentiation — what directs a cell to evolve into kidney, liver or heart tissue, for instance. With each cell type in the body having a unique methylation pattern, or “fingerprint,” MCED uses a combination of novel biochemistry and AI techniques to learn to connect detected cancers to their likely tissue of origin.

A whole-system, individual approach

MCED tests can simultaneously screen for signals of dozens of cancers — the vast preponderance of which currently enjoy no effective screening technique — with a potentially high degree of accuracy, opening a new frontier of cancer screening possibilities. As Dr. Chetan Bettegowda of Johns Hopkins University explains, MCED introduces the potential “to transform the concept of cancer screening from an organ-by-organ, site-by-site, to a whole system, patient, individual approach.” 

It also introduces the possibility of screening for cancers in the asymptomatic population. This matters greatly, for, as Dr. Norman “Ned” Sharpless, former director of the National Cancer Institute at the National Institutes of Health, notes, “The most common way people are diagnosed with a cancer is when they present to a doctor with a new symptom [subsequently identified as cancer].” Of these, the vast majority are discovered at the latest stage, stage IV. In fact, out of every 100,000 cancers diagnosed in clinical settings, stage IV cancers account for approximately 170, compared with 100 for stage III, 75 for stage II, and 50 for stage I.

Read the full testimony here.

Stephen Ezell is the Vice President of Global Innovation Policy and the Director of the Center for Life Science Innovation at the Information Technology and Innovation Foundation.

_{*The opinions expressed in this column are those of the author and do not necessarily reflect the views of HealthPlatform.News.}