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An Important Medical Breakthrough, and Big Change in the Fight Against Cancer

It is clear that the best way to beat cancer is finding it as soon as possible—when treatment outcomes can be better.

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In fact, when cancers are diagnosed early before they have had a chance to spread, the overall five-year survival rate is four times higher compared to when those cancers are diagnosed in later stages.*

This important connection has put the need to detect more cancers earlier, through a simple method, at the center of scientific advancement.

Current guidelines recommend screening for four out of more than 100 types of cancer. These are widely used screenings, like mammograms or colonoscopies. Yet these screenings only look for signs of a single cancer, leaving many more cancers unscreened and not typically found until symptoms appear.

The need to find more cancers sooner has led to the development of the multi-cancer early detection test. Multi-cancer early detection tests rely on a blood sample to detect the presence of cancer. Then, if cancer is detected, additional tests like blood work or imaging are done to diagnose the cancer.

One of these multi-cancer early detection tests is the Galleri® test. With a simple blood draw, the Galleri test can detect a common cancer signal across over 50 types of cancer. Not all cancers can be detected in the blood or by the Galleri test. The Galleri test is not a genetic test and does not predict future risk of developing cancer. The Galleri test does not replace other cancer screening tests, adding the Galleri test to routine cancer screenings could improve the chance of finding more cancers early.

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The development of this multi-cancer early detection test came out of different scientific research. It started in 2013 when a doctor was studying the use of a blood test for another screening procedure. During this research, they found that cancer can be detected in the blood. This discovery led to further research into the development of an early cancer screening test and the Galleri test.

The Galleri test is designed to detect DNA from cancer cells in the blood. All cells in the body release DNA into the blood stream, but DNA from cancer cells looks different from the DNA of healthy cells. DNA from cancer cells can be used as a cancer signal. The Galleri test looks at the DNA in the blood to determine if any of it may have come from cancer cells. If the Galleri test detects a cancer signal, it also predicts the likely location of the cancer signal. This helps a healthcare provider determine next steps to confirm if cancer is present.

The development of Galleri was supported by clinical studies with over 20,000 participants. These clinical studies were conducted across the country, including leading cancer institutes like the Cleveland Clinic and Memorial Sloan Kettering Cancer Alliance.

Like other recommended cancer screenings, the Galleri test is not for everyone. The Galleri test is recommended for use in adults with an elevated risk for cancer. Adults aged 50 years and older have a 13x increased risk of cancer. The Galleri test is available by prescription only and can be requested through a person’s healthcare provider or a telemedicine partner. The Galleri test is not recommended for individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Read more about the breakthrough science of multi-cancer early detection and the Galleri test at galleri.com.

To request the Galleri test through a telemedicine partner, click here.

*American Cancer Society (ACS) states in Cancer Facts & Figures 2022 “Finding cancer at its earliest stage, when it might be easier to treat, gives patients the greatest chance of survival.”

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 “Cancer Signal Not 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. 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.

©2022, GRAIL, LLC. ALL RIGHTS RESERVED. GALLERI IS A REGISTERED TRADEMARK OF GRAIL, LLC.

Everyday Health does not endorse any specific product, service, or treatment.