Candace Westgate, DO, medical director and founder of Adventist Health’s Early All-Around Detection (AHEAD) program in St. Helena, Calif., has always been passionate about cancer risk assessment and early detection. This passion and focus are what led her to establish AHEAD.
Becker’s Healthcare recently spoke with Dr. Westgate to learn about the AHEAD program and how it works, how AHEAD benefits at-risk and underserved populations and the role of multi-cancer early detection (MCED).
AHEAD 1.0: Helping patients and providers stay ahead of cancer through genetic testing
When Dr. Westgate developed the AHEAD program in 2017, her goal was to detect cancer early through personalized and comprehensive cancer risk assessments. Using evidence-based standards, Dr. Westgate identified patients meeting criteria for genetic testing for hereditary cancer syndromes. These tests identified patients with genetic mutations and, when appropriate, provided access to genetic counselors and necessary screening.
“I realized this was fantastic — we were able to say we’re preventing cancer,” Dr. Westgate said.
However, as exciting as the initial version of the AHEAD program was, Dr. Westgate recognized that inherited genetic mutations account for only about 10% of cancers.
“Ninety percent of the time when people get cancer, it’s because of just living in the world we live in: aging, exposure to carcinogens, plastics, pesticides, smoke inhalation, poor diet, drinking too much alcohol, smoking cigarettes, getting a virus — and so much more,” she said. “All of these things increase the risk of developing cancer.”
AHEAD 2.0: Incorporating MCED testing
In looking for ways to expand AHEAD to detect more cancers earlier, Dr. Westgate realized there were only screening guidelines for five cancers — cervical, colon, breast, prostate and lung.5 Each of these screenings is designed to detect one cancer, and the majority of cancer deaths come from cancers that do not have recommended screenings.6*
When Dr. Westgate learned about the Galleri multi-cancer early detection (MCED) test, screens for a “fingerprint” of 50+ types of cancers,7 she saw it as a completely dfferent paradigm.
“You’re testing an individual for multiple cancers at one time,” she said.
After looking broadly into cancer screening and learning about the Galleri test, including what the test is, its positive and negative predictive value and its sensitivity and specificity, Dr. Westgate added Galleri to the AHEAD program’s cancer screening framework.
Offering Galleri to at-risk patient populations
The AHEAD program aims to make cancer screening comprehensive and personalized. It starts with family history, and where indicated, includes genetic testing. For certain groups of high-risk patients, the AHEAD program includes the Galleri MCED test.
Patients receiving the Galleri test are those with a positive genetic test, and high-risk groups such as first responders — especially firefighters — and farm workers, who are exposed to chemicals and pesticides. To ensure that all at-risk patients have access to the Galleri test, AHEAD has engaged in philanthropic fundraising through the support of the St. Helena Hospital Foundation to fully cover the costs of these tests in the Northern California region.
“We don’t want cost to be a barrier,” Dr. Westgate said. “For individuals who need this, who are at the highest risk of cancer, we can offer this to them for free.”
Coordinating care for positive screening results
At this time, more than 60 clinics are participating in the AHEAD program. The workflow places genetic-trained providers on the back end and empowers each clinic location to identify, screen and test their own patient at the point of care. The team of genetic specialists, led by Dr. Westgate, reviews the results and creates personalized care plans for these high-risk patients. The majority of visits to disclose test results are done virtually, helping with access to care.
To provide the best care for any patient with positive test results, Dr. Westgate has created “circles of care,” which comprise specialists in urology, gastroenterology, breast surgery, general surgery, radiology, oncology, dermatology, ophthalmology and other areas. These specialists have been educated about genetic testing and the Galleri test.
“There’s a significant amount of supporting materials available to educate our providers,” Dr. Westgate said. She noted how these clinicians understand the screening tests and the results, and are able to quickly provide appropriate followup testing and treatment for each patient
based on the patient’s specific test results and circumstances.
“The AHEAD genetic specialty team acts as the quarterback, helping these patients navigate through the system to get the care they need,” Dr. Westgate said. For individuals in the Northern California region where the Galleri MCED test has been rolled out, Dr. Westgate helps patients with a cancer signal detected result to navigate the appropriate diagnostic work-up.
Galleri is enabling personalized medicine
For health systems considering MCED testing, Dr. Westgate encouraged staying curious and learning more about the technology. “This kind of technology has the opportunity to make a significant impact in the fight against cancer,” she said. “We haven’t seen anything even close to this
previously.”
By creating frameworks and pathways, such as AHEAD’s circles of care, it is possible to keep patients within the health system and route them to the right specialist to get the care they need. “Let’s catch cancer when it’s more likely to be treatable and curable,” said Dr. Westgate. Further, AHEAD’s circles of care approach drives downstream revenue for the health system in providing the followup services and treatments that these highrisk patients need.
“My mantra is always comprehensive risk assessment — understanding family history, doing genetic testing, understanding the patient’s risk factors and environmental exposures, and then the right screening at the right time,” Dr. Westgate said.
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.
References
- Cancer Statistics, National Cancer Institute. https://www.cancer.gov/about-cancer/understanding/statistics.
- American Cancer Society. Cancer facts & figures 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html[GRAIL, LLC. Data on file: GA-2021-0065].
- NIH/National Cancer Institute. Detect Cancers Early – National Cancer Plan. https://nationalcancerplan.can cer.gov/goals/detect-cancers-early#.
- Reddy SR, et al. Curr Med Res Opin. 2022;38(8):1285-94.
- US Preventive Services Task Force. A,B,C grade recommendations, cancer, screenings [cited 2023 Oct 23]. https://www.uspreventiveservicestaskforce.org/uspstf/topic_search_results
- American Cancer Society. Estimated deaths per year in 2022. Cancer facts & figures 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancerfacts-figures-2022.html [GRAIL, LLC. Data on file: GA-2021-0065].
- Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806.
* Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on the estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years).
The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. Galleri does not detect all cancers. False positive and false negative results do occur. The Galleri test identifies DNA in the bloodstream shed by cancer cells and does not predict future genetic risk for cancer. The Galleri test should be used in addition to healthcare provider recommended screening tests. 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.
Galleri is a registered trademark of GRAIL, Inc.
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