Shifting Cancer Detection and Treatment Earlier
Jeffrey Venstrom, MD, Chief Medical Officer | April 6, 2023

We like to think of an elusive “miracle cure” or “silver bullet” for cancer, but it’s more likely that truly transforming cancer today and in the foreseeable future won’t take the form of a new pill, infusion or other medical therapy. While immunotherapies and targeted treatments discovered over the last two decades have improved some individual cancer survival rates—many strikingly so, giving hope to people who previously often faced daunting odds—on a population level, a single medical therapy isn’t likely to offer a broad cure for all cancers. Preventing the disease from occurring in the first place and finding it early when it does are far more likely to reduce the mortality burden of cancer.

A new study published in Cancer Epidemiology underscores the value of early detection to improve cancer-specific survival outcomes across a variety of cancer types. The research, led by Dr. Sana Raoof, a physician at Memorial Sloan Kettering Cancer Center, and GRAIL, used Surveillance, Epidemiology and End Results (SEER) population-level cancer registry data—a data resource that includes more than 1.6 million cancer patients—to identify people aged 50-79 across the U.S. who were diagnosed with first primary invasive solid cancer and received surgical resection. The cancer stages associated with resection were assessed, and patients were followed for up to 12 years.

As expected, the study found that earlier stage at diagnosis allowed for surgical intervention at a much higher rate than later-stage diagnosis across solid tumor types, including cancers of the breast, colon and rectum, lung, pancreas, ovary and more. For each cancer type, eligibility for surgery was associated with substantially improved 12-year cancer-specific survival compared to patients deemed ineligible for surgery.

These findings showed that the potential for definitive intervention is highly dependent on stage at diagnosis—with a much higher rate of successful surgical intervention at early stages—and surgical resection is associated with better long-term outcomes consistently across cancer types. Candidacy for surgery is time-limited and identifying patients who can best benefit from this potentially curative intervention is crucial. Further, these findings suggest that eligibility for surgery could be a clinically meaningful endpoint for cancer screening trials.

To take advantage of these data, we need a new approach for finding more cancers earlier, when treatment is more likely to be successful. Multi-cancer early detection (MCED) offers a new population-scale approach for screening people that finds more cancers (by detecting a shared signal) before symptoms appear, in early stages.

People whose cancer is detected early have a wider range of therapeutic options including surgical resection, treatment may be less complex and costly, and outcomes are likely to be more favorable. Yet, while early diagnosis and treatment are associated with improved outcomes, many cancers are still diagnosed too late for curative therapy.

In the PATHFINDER study, GRAIL’s MCED test, Galleri®, when added to standard-of-care screening, more than doubled the number of cancers diagnosed compared to standard screening alone. Additionally, nearly half of the non-recurrent cancers detected by the MCED test were found in early stages (Stage I or II).

The Galleri test analyzes methylation patterns on cell-free DNA (cfDNA) shed in the blood from cancer and non-cancer cells. Using genomic technology and machine learning, Galleri can detect a cancer signal shared across more than 50 types of cancer in people at elevated cancer risk with a simple blood test. This allows healthcare providers to determine next steps for diagnostic evaluation and potentially identify cancers before people show symptoms.

Modeled data suggests that MCED testing enables scalable, population-level stage shift to reduce late-stage diagnosis of cancer, in conjunction with standard single-cancer screenings like mammography and colonoscopy. A stage shift resulting in a significant reduction in late-stage cancers simply isn’t feasible with the current five individual screening tests recommended for the general population today.

Effective treatments, alongside public health efforts focused on cancer prevention, are vital. But many cancers are caused by factors that aren’t preventable, and with an aging society, cancer will continue to affect the health and lives of millions of people. MCED is a novel approach that offers the best chance to detect, and ultimately diagnose many types of cancer early, and it is technology we can start to take advantage of now.


Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.