Adopting Multi-cancer Early Detection Testing Today

How leading health systems like HCA Healthcare and Providence evaluated and implemented multi-cancer early detection (MCED) testing to increase the chances of improving patient outcomes

Consider these facts: In the U.S., only 5 types of cancer — colorectal, breast, cervical, prostate, and lung (for those at risk) — have recommended screening tests that can identify cancer early.¹ However, nearly 70% of deaths are caused by cancers that don’t have recommended screenings, including aggressive cancers such as pancreatic, ovarian and liver.2^*† When cancer is diagnosed early,^§ before it has time to spread, the overall 5-year cancer-specific survival rate is 4 times higher than when cancer is diagnosed late.³

Making meaningful progress on improving cancer outcomes will require screening to identify more cancers, and at earlier stages, when they may be more treatable.^4,5 Accomplishing this requires a fundamentally different approach than developing a series of single-cancer screening tests, which may be impractical, inefficient and costly - and will not be able to address less common cancers.⁶

This could also overwhelm the healthcare system with false-positive results, because sequential single-cancer tests would have additive false-positive rates.^7,8

Multi-cancer screening provides the opportunity to screen for many cancers.⁹ The Galleri® test is a multi-cancer early detection (MCED) blood test that detects a signal shared by multiple cancers, including many cancers with no recommended screening tests.^1,9 Galleri has a low false positive rate (0.5%) and highly accurate prediction of the cancer signal origin (tissue type or organ associated with the cancer signal).^{10 ¶} This helps guide the diagnostic workup and minimize unnecessary diagnostic procedures. Based on modeled data, adding the Galleri test to annual wellness visits along with recommended screenings can improve the chances of finding cancer early, when it may be more treatable.^1,11

Offering MCED testing is a differentiator for healthcare organizations in today’s competitive marketplace

Providing a positive patient experience is becoming an increasingly complex task for health systems amid evolving patient preferences, consumerism and imperatives to improve care quality and safety measures. Rising rates of cancer in adult patient populations have also brought cancer into focus as health systems strive to improve clinical outcomes.¹²

Bending the cancer mortality curve is difficult; however, early detection tools like MCED tests that screen for many of the deadliest cancers through a single blood test have the potential to change this paradigm.^2,9 

There are lessons to learn from leading health systems, such as Providence (Renton, Wash.) and HCA Healthcare (Nashville, Tenn.) — two major systems among dozens that have already successfully adopted MCED screening.

“As a large, integrated, faith-based and multi-state health system, Providence is committed to whole-person care, especially to those most vulnerable,” Ora Gordon, MD, clinical director of Providence’s Population Health Genomics Program said. “This includes investigating innovative technologies and making decisions about how to bring them forward thoughtfully.”

As a system, Providence made a commitment to embed genomics and MCED testing into the core of how it offers care. After reviewing validation studies from GRAIL, such as the Circulating Cell-Free Genome Atlas (CCGA)⁶ and PATHFINDER⁷ studies, the organization initiated its own implementation research to study the Galleri test in 2021.

“We have begun by observing the implementation of Galleri to gain experiential learning on MCED tests in practice within key, elevated-cancer-risk patients who are often challenging to treat in primary care — those with hereditary risk, familial risk and cancer survivor risk,” Dr. Gordon said.

Now, Providence has a few years of experience and data on the Galleri test. “This helped us tailor our provider and patient education and create an earlydetection case conference open to all providers,” says Dr. Gordon.

Current data from Providence’s research are consistent with GRAIL’s published clinical study data on the Galleri test performance.

Dr. Gordon expects that MCED testing will gain greater adoption industrywide. “Over time, I am confident the paradigm shift will move toward use of MCED tests to allow greater patient access to cancer screening, enhanced tools for risk stratification, and likely the evolution of therapeutics informed by MCED screening.”

From an operations perspective, health systems want primary care providers to oversee more care and treat the whole patient. This means focusing on prevention as well as treatment of chronic diseases. In light of current staffing shortages, any new initiative or technology — including MCED screening — must be simple and easily integrated into existing workflows.

"Given the ever-increasing demands on the primary care community, it’s been critical for our health system to develop processes and tools to identify and introduce MCED testing to our patients before they even see their provider,” Dax Kurbegov, MD, senior vice president of the HCA Healthcare Sarah Cannon Cancer Network said. “This streamlines the provider discussion and ordering process for the provider while offering our patients multiple opportunities to be better informed about testing.”

Dr. Kurbegov underscored the importance of health systems supporting providers in the screening process with clarity and resources. “Because Cancer Signal Detected results from Galleri are relatively rare for an individual provider, we’ve implemented evidence-based pathways and oncology navigation services to ensure both patients and providers are supported through any diagnostic workup,” he said.

As healthcare organizations try to differentiate in an increasingly competitive marketplace, adopting MCED testing is a signal to communities that a health system is an innovator. GRAIL’s early partnerships with Providence and HCA Healthcare to implement Galleri are evidence of this commitment.

MCED testing: Striking the right balance between short- and long-term considerations

As hospitals and health systems consider MCED testing, they must balance near-term concerns — like urgency of implementation and existing clinical validation and safety data — with longer-term issues like the desire for clinical utility and outcomes data.

Historically, clinical utility has meant survival, and some have suggested waiting to implement MCED tests until survival data is generated. However, survival data takes a decade or more. In the meantime, lives are lost each day to cancer. It’s necessary for healthcare organizations to assess other intermediate endpoints to ensure timely adoption of MCED testing. The box below shows studies analyzing these endpoints.

“As we have learned more about implementation, we recognized that a yearover- year study like PREVAIL could yield even greater insights on how to implement MCED,” Dr. Gordon said. “Whether we are identifying a patient as at-risk, the patient has selfidentified as at-risk or the patient is generally interested in availing themselves of new screening technologies, it is incumbent on us as health system leaders to meet patients where they are with what is available to support their health care journey.”

Dr. Gordon noted her confidence in Providence’s strategy and educational reach within the health system. “Our multipronged approach to how and where we offer Galleri to our patients has allowed us to scale lessons across our provider network, making it easier to build MCED testing into our routine screening practice,” she said.

The road ahead: accelerating the positive impact of MCED testing

Health systems across the U.S. are adopting MCED tests based on the existing, robust clinical validation and safety data, while working toward confirming the clinical utility with timely endpoints from year-over-year screening studies. Continued, broad MCED adoption across U.S. healthcare settings allows access to this transformational technology today. Understanding what it takes to implement this technology; how health systems are using it; and how patient outcomes may be impacted creates an opportunity to generate informative, real-world evidence that can inform health system adoption today.

Important 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 No Cancer Signal 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

The GRAIL 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 Food and Drug Administration. The GRAIL clinical laboratory is regulated under CLIA to perform highcomplexity testing. The Galleri test is intended for clinical purposes.

* Sensitivity in study participants with - Pancreatic cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Ovarian cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).

† Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years)

§ “Early/Localized” includes invasive localized tumors that have not spread beyond the organ of origin; “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.

¶ The Cancer Signal Origin (CSO) prediction accuracy is 93.4% for those with a Cancer Signal Detected result.

References

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10. GRAIL, Inc. Data on file: VV-TMF-59592 on clinical validation analysis in a subset of CCGA3 and PATHFINDER study participants.
11. Sasieni P, Clarke CA, Hubbell E. Impact of MCED screening interval on reduction in latestage cancer diagnosis and mortality. European Society for Medical Oncology (ESMO) Virtual Congress [poster]; 2021 Sep 16-21.
12. Becker’s Hospital Review. “Cancer rates in younger adults.” April 2024. https://www.beckershospitalreview.com/oncology/cancer-rates-in-younger-adults-4-trends-to-know.html