Rush is now one of the largest U.S. health systems — and the first in the Chicago area — to offer Galleri, a blood test that detects over 50 types of cancer, often before symptoms appear.
“Recommended screening tests are the best way to find cancer in early stages, resulting in much higher cure rates and lives saved,” says Lisa Stempel, MD, director of the Rush’s high risk cancer screening program. “But right now, screening tests are only available for five cancers, while more than 70% of cancer deaths are caused by aggressive cancers that do not have regular screening tests, like bladder, head and neck, liver, lymphoma, ovarian, pancreatic and stomach cancers.”
Galleri’s blood test stands out as a promising tool, as it screens for many cancers that lack routine screening options, like bladder, head and neck, liver/bile duct, lymphoma, ovarian, pancreatic and stomach cancers. The test also has a low false positive rate — just 5 in 1,000 — and can identify the location of the cancer with 90% accuracy when a signal is detected.
“By incorporating the test into our broader, high risk screening program and offering it through Rush primary care,” Stempel says, “more patients will benefit from both cancer screening and cancer intervention.”
This test does not replace routine screenings like mammograms or colonoscopies but works alongside them.
“Our studies have shown that adding Galleri to routine screenings can more than double the number of cancers detected, and about half have been found to be at an early stage,” says Josh Ofman, MD, MSHS, president at GRAIL, the company that developed the Galleri test. “We applaud Rush for offering the Galleri test in addition to currently recommended screenings, as a step forward in the needed paradigm shift in cancer screening.”
How the Galleri blood test works
Billions of cells, including cancer cells, die in the human body each day, releasing DNA fragments into the bloodstream. GRAIL uses next-generation sequencing and AI-powered algorithms to isolate these fragments and analyze whether a cancer signal is present.
The Galleri test development has been supported by one of the largest clinical study programs in genomic medicine, with a clinical evidence program that includes more than 380,000 participants in completed or ongoing studies.
In the PATHFINDER study, adding the Galleri test to standard-of-care screening nearly doubled the number of cancers detected. This included early-stage cancers and those without recommended screening. The test also showed an 88% accuracy in predicting the cancer signal origin.
A cancer signal detected result is expected to occur in about 1 out of 100 Galleri tests in people over age 50. It is important to note that a positive cancer signal detection is not a cancer diagnosis. A cancer signal detected result will also include a prediction of the tissue type or organ associated with the signal, providing direction to physicians on the cancer’s origin and helping to guide the next steps in diagnosis.
Enlisting primary care in cancer detection
Earlier this month, Rush primary care physicians have been able to recommend the Galleri blood test to patients over 50 and those under 50 who have other known cancer risks such as a smoking history, family history of cancer, heavy alcohol use or obesity.
Blood draws for the Galleri multi-cancer early detection test take place at all three Rush hospitals and RUSH MD Anderson Cancer Center at Rush Lisle before being processed at GRAIL’s laboratory. Patients will receive test results from their clinician and via MyChart generally within four weeks of their blood test. They will also receive a follow-up call from a Rush nurse practitioner to review the results. Non-Rush patients and providers interested in learning more about the Galleri test can visit us online for more information.
“Primary care providers are proud to be on health care’s front line in helping people live longer, healthier lives,” says Michael Hanak, MD, a Rush family physician and department lead for this effort. “Being able to order lung cancer screening or colonoscopies for at-risk patients has long been among our most important tools. A single blood test for those at risk for other forms of cancer could mean earlier detection for more patients with better outcomes and peace of mind.”
The Galleri test is covered by some insurance companies, such as TRICARE, one of the largest health plans in the U.S., which serves active-duty service members, National Guard and Reserve members, retirees and their families. For others, the test prescribed by Rush providers currently requires an out-of-pocket payment of $749. Health Savings Accounts can be used, and Rush is working to assure those who cannot afford the out-of-pocket cost will still be able to access the test.
“Cancer is a scary, complex, but increasingly survivable disease. While it remains the country’s second leading cause of death with nearly 1,700 people dying each day, decades of research and technology breakthroughs support the simple fact that the early detection results in people living longer, healthier lives,” Stempel says. “With 1 in 3 people expected to develop cancer during their lifetime, we are proud that Rush patients will be able to benefit from an easily administered test delivered in a primary care setting.”
Important Galleri safety information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a health care provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test is not recommended in people who are pregnant, 21 years old or younger, or undergoing active cancer treatment.
Results should be interpreted by a health care 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.\
Laboratory/test information
The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 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 Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity testing. The Galleri test is intended for clinical purposes
