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In 2020 (the most recent year for which federal U.S. incidence data are available), 1,603,844 new cases of cancer were reported and 602,347 people died of cancer. Despite substantial progress in prevention, screening, and treatment for more of its common forms, cancer remains the second leading cause of death in the U.S. (2022), surpassed only by heart disease. A stated goal of Healthy People 2030 reads, "Reduce new cases of cancer and cancer-related illness, disability, and death." This will be a heavy lift!
The hard truth is that a continual reduction in cancer death rates will require new, more comprehensive capabilities for detecting the more than 100 distinct types of cancer at earlier stages of the disease. Currently, national organizations recommend preventive screening tests for only five common cancers (i.e., breast, colorectal, cervix, lung, and prostate); these account for approximately 30% of all malignancies. With few exceptions, no screening is recommended for the remaining 70% of cancers at the population level. Of these cancers, many types with high mortality rates lack a specific mode of early detection.
The rapid advancement in cancer biology has spurred an evolution in our approach to early detection of cancer through asymptomatic screening. Greater understanding of biomarkers has greatly expanded our ability to identify cancers across a range of anatomic sites, and there is rapidly growing interest in new technologies that enable early detection for multiple cancers with a single assay.
Of all the recent and ongoing advances in cancer detection technology, I am most interested in and encouraged by the multi-cancer early detection (MCED) technology because of its potential value as a diagnostic tool for clinicians and a screening device for broader population subsets.
What is MCED?
The term MCED refers to an emerging set of laboratory technologies that enable rapid screening for over 50 cancer types from the same (generally blood) specimen. MCEDs are designed to detect "cell free DNA" that circulates in the blood following cancer cell breakdown. Tests generally look first for circulating DNA and other substances that may be present in different types of cancer.
In the U.S. today, a range of MCED tests are in development, being tested, or commercially available for cancer detection. Various test approaches (i.e., analysis of blood, breath, and other biological specimens) are designed to indicate if a cancer signal is present, and some provide additional molecular information about likely organ of origin.
It is important to note that MCED is not a panacea. It may lead to diagnosis of a cancer for which a person has an inherited risk; however, the test does not assess inherited genetic predisposition or risk of developing cancer. The test may provide information about the likely origin of a cancer (e.g., listing the most likely organ when there is more than one option).
How will MCED be used?
MCED tests are currently being studied in multiple large-scale clinical trials to further demonstrate their clinical benefit. Three of these tests have been designated as "breakthrough devices" by the FDA; however, additional FDA approvals are required before MCED tests are included in screening guidelines.
Early clinical trials suggest that, when combined with existing approaches for single cancer screening, MCED tests could assist clinicians in identifying a broader range of cancers earlier in the course of the disease, thereby raising the likelihood of more effective treatment and improved outcomes. These technologies may also be useful as screening tests for broader populations.
Led by a cross-section of healthcare and research professionals dedicated to MCED technology awareness and education, the MCED Consortium is working proactively to evaluate and assess the benefits and risks of these new technologies, develop guidance for their introduction into clinical care, and consider other important aspects such as cost-effectiveness and equitable access to tests.
Without recommending a particular test, the consortium's Care Delivery Work Group recently proposed a care pathway for the use of MCED tests. Their aim is to help primary care providers understand that, although MCED does not replace current standards of care (i.e., regular cancer screening for average-risk, asymptomatic patients), it may be a valuable complement to regular screening for appropriate patient populations.
Who among us has not known a seemingly "healthy" person diagnosed with a late-stage cancer? Cancer can be insidious, and it is scary! When my life insurance company offered me a coupon for a free MCED test, I jumped on the opportunity to learn a bit more about my risk of the disease. A negative test result was incredibly reassuring to me at this point – but I'll continue to get all of my routine cancer screening tests in the future.