Dear Patients and Friends,
What follows is one doctor’s opinion and not medical advice. I do not have any financial interest in this new technology, and I do recommend you get consulted before deciding to get this done!
There are new molecular tests that can detect cancer on the market that continue to be studied. These tests look for RNA (like DNA) patterns to find cancer early through a simple blood draw. None of these tests are FDA approved yet, but I believe in time this will prove to be the future of cancer detection especially as we get older. We are already using molecular genetics tests to identify how best to treat cancer, it was only a matter of time before the same technology could be used to FIND cancer. Finding cancer early is IMPORTANT because it may lead to a better chance of survival.
Note: This is not usually covered by insurance yet, but compared to the value it is affordable.
The test we are currently using is called Galleri®, and it is the first of its kind multi-cancer early detection test that screens for a signal shared by multiple cancers, many without a recommended screening test. In a clinical study, the test was able to detect more than 50 types of cancer with a simple blood draw. 1,2
When cancer is caught in its early stages, there may be more treatment options. And according to the clinical data, Galleri has a specificity of 99.5%, which means that it has a low false positive rate of 0.5%. A low false positive rate helps minimize unnecessary diagnostic procedures.
Here are few benefits of the test:
- It detects a signal shared by many cancers including those that are not commonly screened for today.
- It can be incorporated into a wellness visit through a simple blood draw.
- If a cancer signal is detected, the results can predict where in the body the cancer is coming from to help us guide your next steps.
Things to consider with your doctor:
- Looking for cancer can be scary, do it in concert with your doctor.
- Insurance will not cover this, so consider the expense vs the benefits with your doctor.
- While this may be an exciting new technology, and has been studied in thousands of patients, it is not approved by the FDA yet.
To see a full list of the cancers this test can detect, visit What can the test detect?
Please call our office at 480-991-9271 to schedule an appointment to discuss if the Galleri test may be right for you.
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. It is intended to be used in addition to, and not replace, other cancer screening tests.
The Southwellness Team
- 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;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806.
- Amin MB, et al. (Eds). American Joint Committee of Cancer (AJCC) Cancer Staging Manual (8th edition)
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
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.