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GALLERI Multi-Cancer Early Detection

By Dr. Heidi Puc

Cancer will soon be the leading cause of death globally, and while the development of more effective treatments is needed, many may only prolong survival by a few months, if at all. Early detection of cancer is extremely important, as it can not only decrease the death rate, but also can reduce treatment-related side effects, increase the likelihood of treatment success, improve quality of life, and decrease treatment cost and complexity. Currently, only five cancer types have screening protocols in place (breast, colorectal, cervical, lung, and prostate cancers). Although screening for early detection has reduced deaths from these five cancer types, these cancers together account for only 42% of annual cancer incidence in people aged 50-79 years. It is known that three-quarters of all new cancer cases and cancer-related deaths are due to cancers that do not have established screening guidelines. These cancers often are diagnosed at more advanced stages when a cure is less likely, and treatment is less effective and more costly. We also know that age is the single most important factor for developing cancer, and people aged 50 and older are 13X more likely to develop cancer than those under 50.

Having a blood test that can identify a variety of cancers at an earlier stage could be extremely helpful when used in conjunction with cancer screening tests, or for cancers in which no good screening tests exist. The Galleri test from Grail, LLC is a multi-cancer early-detection blood test that IM of CNY is pleased to introduce to our community. The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older (but can be done in a younger population as long as they are at least 21 years of age). The Galleri test is intended to be used in addition to, and not replace, other cancer screening tests your healthcare provider recommends. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

So how does the Galleri test detect cancer? It is known that all cells in your body, including cancer cells, release DNA fragments known as cell-free DNA into the bloodstream. The DNA from cancer cells is different from the DNA of healthy cells. DNA from cancer cells has specific methylation patterns that identify it as cancer, and the specific pattern can also tell where in the body the cancer is arising from.

There are, of course, some limitations to the test. 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 coming from. It preferentially detects cancers associated with high death rates, such as cancers of the anus, bladder, colon/rectum, esophagus, head and neck, liver/bile duct, lung, ovary, pancreas, stomach, as well as lymphomas and plasma cell neoplasms (related to multiple myeloma). A test result of “cancer signal not detected” does not rule out cancer. A test result of “cancer signal detected” requires confirmatory imaging or test procedures 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 and false-negative test results do occur, however, the Galleri test has a 99.5% specificity (in 99.5% of cases it accurately reveals those that do not have cancer present) with a low false-positive rate of 0.5% and an 89% accuracy in predicting origin of cancer if the test is positive. Because this test is not yet FDA-approved, it is a direct pay test, but Galleri has a 12-month interest-free payment plan to cover the cost of the test.

IM of CNY is excited and proud to offer this innovative multi-cancer early-detection blood test to our community and beyond, and we are now scheduling consultations for both non-patients and established patients!

If you are not currently a patient of IM of CNY and are interested in the Galleri testing, we are offering a pre and post-testing consultation appointment. After a short consultation at IM of CNY to review the testing information with you and to determine if the testing is appropriate, we can draw your blood for the Galleri lab if you are found to be eligible. We will send your blood to Grail, LLC (located in California and North Carolina, US), the company that created and performs the Galleri test.

Grail will report the results of the test to IM of CNY, results will be interpreted by Jennifer Kohler FNP, at IM of CNY, in conjunction with Dr. Puc, in the context of medical history, cancer risk factors, and clinical signs and symptoms. At the post-testing consultation, we will share the test results with you and will counsel you on the findings. Either a cancer signal will be detected, or it will not be detected. Depending on the test results and other clinical findings and risk factors, we may recommend that additional follow-up tests are needed to confirm if cancer is present based on the results of the Galleri test. This may involve a referral to appropriate specialists or to your primary care doctor.

We are very excited to be offering this multi-cancer test and encourage you to contact our office for more information on our Galleri lab testing consultations!

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