The benefits of early detection are clear: The earlier that cancer is diagnosed, the greater the chance of successful treatment and survival for the patient,1,2 and the more directed and efficient care delivery is for the health system. While health system leaders recognize the tremendous value of early cancer detection, many are unsure of how to launch multi-cancer early detection (MCED) testing programs, and integrate those programs into existing workflows at their organizations.
During a recent panel discussion, leaders in early cancer detection at health systems discussed the potential impact of MCED programs, the MCED programs that they have established at their institutions, and recommendations for organizations that are considering implementing MCED testing programs. The expert panelists were:
- Elizabeth O’Donnell, MD, Director of the Multi-Cancer Early Detection Clinic, Dana-Farber Cancer Institute in Boston
- Candace Westgate, DO, Chief of Staff, Adventist Health St. Helena (Calif.) and Founder/Director of the Adventist Health Early All-Around Detection (AHEAD) Program
Physicians and other members of the healthcare community attended the event to hear Dr. O’Donnell’s and Dr. Westgate’s insights, including leaders from Mayo Clinic, HCA Healthcare, City of Hope, Mercy, University of California San Diego Health, University of Chicago Medicine, and more.
Here are key takeaways and recommendations for leaders interested in building MCED programs at their health systems.
With MCED testing, health systems can screen for multiple cancers at population scale
Health systems are well-positioned to efficiently screen large numbers of patients with MCED testing, conduct diagnostic workup for patients with Cancer Signal Detected results, and get those diagnosed with cancer into treatment.
Galleri®, a multi-cancer early detection (MCED) test from GRAIL, screens for a signal shared by many of the deadliest cancers that currently lack screening options, such as pancreatic, ovarian, liver/bile duct, and others.* The Galleri test identifies DNA shed by cancer cells into the bloodstream. For patients who receive a cancer signal detected result, the Galleri test will predict the most likely origin of the cancer signal, helping guide the diagnostic workup.
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 is intended for asymptomatic patients and should be used in addition to recommended single-cancer screening tests.
Currently, single-cancer screenings play an important role in detecting 5 specific cancers* (breast, cervical, colorectal, lung and prostate) and have been shown to decrease cancerspecific mortality for the individual cancers that they detect. However, nearly 70% of deaths are caused by cancers that don’t have recommended screenings.
“What excites me about MCED testing is the potential to increase access. Who has access to screening and who gets screening is very suboptimal. Blood-based testing is really important to address this,” Dr. O’Donnell said. “Our ultimate goal is to increase cancer screening access and equity.”
For rural patients, access to specialized cancer facilities or academic medical centers may be especially challenging.“ Patients in rural communities do not have access to a multitude of things,” Dr. Westgate said. “We need to offer screening where they are. What better way than one blood test to screen for multiple cancers versus screening for individual cancers one by one?”
*Galleri should be used in addition to recommended single-cancer screening tests.
Multi-disciplinary collaboration helps patients access MCED testing and get appropriate, timely follow-up care
Primary care and OB-GYN practices are wellsuited entry points for patients to get MCED tests. For patients who have a Cancer Signal Detected, these practices can utilize established referral networks for patients to receive expedited diagnostic workup and treatment.
Dr. Westgate has tested over three thousand patients with the Galleri test. She and her staff identify patients with an elevated risk of cancer using electronic health record data and patient questionnaires. She has had several Cancer Signal Detected Galleri test results with a predicted Cancer Signal Origin of a tissue or organ not traditionally treated in gynecology.
With one patient, Dr. Westgate recommended the Galleri test due to her age, family history, BMI and BRCA1 pathogenic mutation status. The patient received a Cancer Signal Detected result; the Galleri test predicted a Cancer Signal Origin of plasma cell lineage. Dr. Westgate immediately gathered the patient’s circle of care, including oncology. Ultimately, this patient was diagnosed with multiple myeloma and was able to begin treatment before symptoms appeared.
Emphasizing the importance of a strong referral network for patients with a Cancer Signal Detected result, Dr. Westgate said “We cannot live in our silos in medicine anymore . . . Everyone coming together is how we will make change happen.”
Setting up MCED programs requires educating primary care providers, specialists, and staff on how to educate patients, order the test, and refer patients who test positive for diagnostic workup and treatment. Medical assistants also play a critical role in identifying MCED test candidates and engaging them before their provider appointment. These staff can discuss the importance of the test and the testing process. This pre-visit education enables the provider to efficiently determine whether MCED screening is right for the patient and, if so, order the test.
MCED tests offer health systems an opportunity to develop new, oncology-adjacent service lines
Health systems are developing creative approaches to establish and expand programmatic offerings and oncology-adjacent service lines. For example, Dana-Farber Cancer Institute’s Multi-cancer Early Detection Clinic receives patients who received a Cancer Signal Detected with the Galleri test. “We’re doing something for the first time — we accept Cancer Signal Detected results coming from outside our system and expedite the diagnostic workup,” Dr. O’Donnell said.
Dr. Westgate and her team seamlessly added MCED testing to their existing screening workflows and made MCED testing a standard of care particularly for high-risk programs. “Galleri fits into our established Hereditary Cancer/Genetic Screening program,” Dr. Westgate said. “We already talk to patients about recommended screenings and have established referral networks. We added the Galleri test into workflows that already exist.”
Specialists who receive patients with confirmed cancer diagnoses use their established multi-disciplinary networks to direct patients to appropriate treatment. As health systems become more familiar with MCED technology and gain experience in post-positive workflows, more specialists will know how to navigate patients to the right care at the right time and support them holistically and longitudinally. “Galleri patients need to be followed through a structured program,” said Dr. O’Donnell. “To that end, we’re seeing the evolution of a new practice that bridges primary care and oncology.”
Office staff are gaining unique expertise as well. Dr. Westgate explained, “One of the most important things for me is that my staff are as educated as I am about the different programs in my clinic. With Galleri, the workflow that we’ve created enables and empowers our office staff to educate patients about the test before seeing me and helping to flag which patients might be good candidates for the Galleri test.”
In addition to building oncology adjacent services around MCED testing, both panelists highlighted the importance of the patient experience with new screening technologies.
While a Cancer Signal Detected result can accelerate the path to early diagnosis and treatment, a negative result gives patients more information about their health. Dr. Westgate stated, “A No Cancer Signal Detected Galleri result is extremely valuable to a patient, especially a high-risk patient. I see their relief when they receive that No Cancer Signal Detected result. It’s more information to manage their health with confidence.”
Starting the MCED journey
A checklist for health system leaders:
- Educate: Bring primary care, oncology, other key specialists, and staff together, educate them about MCED testing and the evidence, and ensure they are prepared to offer the test , conduct diagnostic workup for patients with Cancer Signal Detected results, and get those diagnosed with cancer into treatment.
- Embed: Explore embedding Galleri into existing workflows, talk to patients about adding the test to their current screening plan and set protocols to expedite workups for patients with Cancer Signal Detected results.
- Offer: Inform patients that MCED testing is available and provide educational resources. Ideally, relevant information should be accessible on a health system’s landing page and in provider offices.
- Test, analyze, adapt: Collect data and glean insights after testing a critical mass of patients and adapt the program as necessary to your patient population.
MCED testing and the future of cancer care
While many health systems are committed to improving early cancer screening, there are hurdles related to coverage and guidelines. For example, MCED testing is generally not covered by private insurance.
Further, increasing access to MCED testing may require additional support from legislators. MCED tests are currently not covered by Medicare.
To evaluate the clinical impact of the Galleri test in Medicare beneficiaries, CMS and GRAIL recently initiated the Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare) study. This is a first-of-its-kind real-world evidence study that aims to enroll participants with a specific focus on inclusion of historically underrepresented communities, including seniors and people across diverse racial and ethnic minority groups, as well as socioeconomically disadvantaged and rural populations.3
In England, the National Health Services (NHS) and GRAIL initiated the NHS-Galleri trial, which started enrolling participants in 2021. The NHS-Galleri trial was designed to inform implementation of the Galleri test as a national screening program if recommended by the UK National Screening Committee on the basis of the final study results, which are expected in 2026. The trial was designed with three consecutive years of screening in order to achieve the primary endpoint, which is the absolute reduction in the number of late stage (Stage III and IV) cancer diagnoses.4
”I hope the government and entities who make coverage decisions and guidelines will think creatively. We don’t need to wait 10 years for mortality data study results to make a significant impact,” said Dr. Westgate.
She went on to say, “Cancer prevention is almost impossible. We have the opportunity to catch cancer at early stages, when treatments can make a difference.”
For patients with Cancer Signal Detected Galleri test results, denials for diagnostic procedures are extremely rare. Both panelists shared that insurers have covered diagnostic workups to confirm a cancer diagnosis.
Adding annual Galleri testing to recommended cancer screening offers an increased opportunity for early cancer detection.5 This means increasing the accessibility of MCED testing, educating primary care physicians and specialists, and building MCED programs into existing workflows. As organizations such as Dana Farber and Adventist Health show, it is possible to scale effective MCED programs that can positively impact cancer screening and care delivery across a health system.
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 high-complexity 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); and liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur. Based on a clinical study of people ages 50 to 79, around 1% are expected to receive a cancer signal detected result. After diagnostic evaluation, around 40% of these people are expected to have a confirmed cancer diagnosis.
References
1. American Cancer Society. The cancer atlas. [Internet] Early detection. https://canceratlas.cancer.org/taking-action/early-detection/
2. Etzioni R, Urban N, Ramsey S, et al. The case for early detection. Nat Rev Cancer. 2003 Apr;3(4):243-52. doi: 10.1038/nrc1041
3. GRAIL. REACH Study. July 18, 2024. https://grail.com/press-releases/grail-announces-first-participant-enrolled-in-reach-study-evaluating-clinical-impact-of-galleri-multicancer-early-detection-mced-test-in-the-medicare-population/
4. GRAIL. GRAIL Update on the Accelerated Implementation of Multi-Cancer Early Detection Technology by NHS England. May 29, 2024. https://grail.com/stories/grail-update-on-the-accelerated-implementation-of-multi-cancer-early-detection-technology-by-nhs-england/
5. Hubbell E, Clarke CA, Aravanis AM, et al. Modeled reductions in late-stage cancer with a multi-cancer early detection test. Cancer idemiol Biomarkers Prev. 2021;30(3):460-8. doi: 10.1158/1055-9965.EPI-20-1134
Galleri is a registered trademark of GRAIL, Inc.
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