Breakthroughs in cancer testing could impact lives

(BPT) – Jim Ford felt completely healthy. He didn’t have any symptoms and kept up with recommended cancer screenings. When his doctor suggested he participate in a clinical trial for a new cancer screening test that could detect a shared cancer signal across 50 different types of cancer, he figured he had nothing to lose.But then the test—a multi-cancer early detection test called Galleri®—showed a positive signal. Ford’s diagnosis was confirmed with a CT scan and a PET scan. He was shocked to learn he had stage 2 pancreatic cancer.*He worked with his doctor and had surgery, radiation and chemotherapy.Treating cancer starts with knowing you have itEarly detection of cancer can improve outcomes, including higher survival rates and better quality of life. It also can reduce the cost and complexity of cancer treatment.The challenge is that, although there are more than 100 different types of cancers, only five cancers have recommended screenings in the United States—breast, cervical, colon, prostate, and lung for smokers considered at risk. In fact, approximately 70% of cancer deaths are caused by cancers that don’t have widespread screening recommendations.In addition, because most cancers don’t show symptoms until later stages, they may be found too late when they have already spread and there may not be as many treatment options.Detecting multiple cancers through a simple blood drawMulti-cancer early detection tests, like Galleri, can be used alongside existing recommended screenings to detect cancer earlier. Using the power of next-generation sequencing and artificial intelligence, the Galleri test can detect a shared cancer signal across more than 50 types of cancer through a simple blood draw.The Galleri test does this by examining DNA isolated from blood. All cells in the body shed DNA into the bloodstream, but DNA released by cancer cells is different from the DNA released by healthy cells. This DNA may contain specific patterns that allow cancer to be distinguished from non-cancer.The test looks for a signal present in the blood that could indicate the presence of cancer. If a cancer signal is detected, the test can predict where in the body the cancer signal is coming from with high accuracy and help a healthcare provider determine appropriate next steps.The Galleri test must be prescribed by a healthcare provider and can be incorporated into annual health checks or routine blood work, if appropriate. It is generally recommended for adults with an elevated risk of cancer, such as those aged 50 or older. False-positive and false-negative results do occur, and the test should be used in addition to routine screening tests healthcare providers recommend.Be proactive and take actionOne in two men and one in three women in the United States risk getting a cancer diagnosis in their lifetime, according to the American Cancer Society.Although Ford is now part of that number, the multi-cancer early detection test gave him an opportunity to treat his cancer early, when he had a higher chance of successful treatment.“The surgeon said that I was probably one of the luckiest people she’d ever met, because she almost never sees stage 2 pancreatic cancer. Usually people at this stage have no symptoms, and you don’t find it early,” said Ford.Galleri was designed to improve detection of cancers like Ford’s that are more aggressive and deadly.Thinking about the possibility of cancer can be overwhelming, but people can now take proactive steps to test for many cancers, increasing the chances of finding them early and before symptoms. Learn more about multi-cancer early detection screenings and the Galleri test at galleri.com.* Based on a clinical study of patients ages 50-79, around 1% are expected to receive a Cancer Signal Detected result, which includes Cancer Signal Origin(s). After diagnostic evaluation, about 40% of people are expected to have a confirmed cancer diagnosis. Galleri test overall sensitivity in participants with pancreatic cancer was 83.7% (61.9% for stage 1, 60.0% for stage 2, 85.7% for stage 3 and 95.9% for stage 4).Important Safety InformationThe 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 InformationGRAIL’s 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 U.S. 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.