Unscreened cancers account for ~70% of US cancer deaths; however, early diagnosis is transformative, with up to an 89% survival rate, depending on the disease and stage. Multi-cancer early detection (MCED) tests are a new simple blood-based solution to screen for multiple cancers, like Galleri, which screens for more than 50 cancer signals—shifting from screening for individual cancers to screening individuals for cancer as a whole. We will share our approach to MCED, which fuels our mission: to detect cancer early—when it can be cured.

Recent research shows the potential to detect multiple cancers early with a single blood test. The evidence standard for screening tests has been long-term randomized controlled trials with a survival endpoint, but these are challenging to conduct. The use of “real-world evidence” as part an alternative evaluation approach holds promise. We describe a set of recommended data elements that will address key questions in the evaluation of MCED tests.

Designing a clinical trial to assess a variety of MCDs for their utility as cancer screening tools presents new challenges compared to traditional single cancer screening modalities. In this presentation, the CSRN program officer will provide an update on the launch of the Cancer Screening Research Network and discuss its objectives. The Network’s first priority will be the Vanguard study, a pilot to assess the feasibility of a platform MCD randomized control trial.

With the available screening tests, most cancers are diagnosed too late, thereby offering little hope for effective treatment. There is a burgeoning array of technologies that are allowing early detection of cancer using the latest molecular and computational tools for analyzing circulating free DNA (cfDNA), ushering in a new paradigm of multi-cancer early detection (MCED) using a pinch of blood. Blood is most suited for noninvasive detection of cancer biomarkers, as it contains circulating tumor cells and fragments of tumor cell-free DNA (cfDNA). MCED tests can analyze genomic features of circulating cfDNA and distinguish these from background genomic signals. This multi-cancer ability to identify individual’s risk of developing any cancer type, many of them do not have regular screening tests in clinical practice. Although these innovative technologies offer hope to patients, MCED tests also force us to carefully analyze the benefit/harm balance and how it may leverage and benefit from that associated with current screening modalities targeting single cancers.

The field of liquid biopsy for cancer early detection has expanded considerably. Effort has proceeded under two parallel tracks, one focusing on single common cancers and another on multi-cancer detection. A wide world of biomarker testing platforms have been explored. The merits of single cancer vs. multi-cancer tests based on a single platform or a combination of platforms require assessment based on performance and cost effectiveness.

Blood-based multi-cancer early detection (MCED) tests represent a new paradigm for cancer screening. Their development addresses a significant unmet need by expanding detection to include the ~70% of cancers that are missed by current screening modalities and that result in >600,000 cancer deaths yearly in the US. MCED testing holds promise to improve screening efficiency and reduce cancer deaths. Several studies demonstrate that MCED tests have the ability to detect a broad spectrum of potentially lethal cancers, to predict the cancer type, and to do so with a very high specificity to limit false positive results.

This session will provide an overview of the Blood Profiling Atlas in Cancer (BLOODPAC)’s soon-to-be-published lexicon of key terms in MCED and single-cancer early detection, created through collaborative discussion involving major assay developers, pharmaceutical companies, academic institutions, and not-for-profits working in the cancer early detection space.

Risk assessment for cancer has typically been approached by a single cancer type at a time. This approach helps both elucidate the etiology of each cancer type and assess risk to inform screening guidelines for several common types of cancer such as breast, colon, and lung. Unlike current guidelines for different individual types of cancer, newer technologies have the potential to target detection of several cancers in a single test, and this will require rethinking how we assess risk and inform screening guidelines. Specifically, it will be important to understand the populations who will most benefit from using multi-cancer early detection (MCED) tests and the risk factors associated with risk of developing any cancer along with individuals at high risk of individual cancers.

In a sample of 125 primary care patients, 79% reported a high level of interest in having an MCED test. Interest in testing was not associated with sociodemographic background, but was positively associated with the following expectations: testing would be recommended in routine care, be convenient, and be effective in finding early cancer (OR=11.70, 95% CI: 4.02, 34.04, p < 0.001. Research is needed on patient uptake of MCED testing along with standard of care cancer screening. Health systems should support patient educating about the pros and cons of MCED testing and shared decision making in diverse populations.