Cancer Signal Detected with a Cancer Signal Origin for colon

"Galleri caught it really early for me." - Mary

Mary’s Experience with the Galleri test

[Mary] I found out real quickly that if you kept moving, you lived longer and a higher quality of life. So, I wanted to keep moving and be active and be involved in life.

My name is Mary. I live in Naples, Florida. I love it here. It's a beautiful place to live because it's conducive to my lifestyle.

So, I just had a physical, my annual physical. Had everything run in September, October. Did the blood draws and things like that. In November, we met with my doctor and he's like, 'Great, Mary. You're fabulous. Outstanding. Keep doing what you're doing. You're just right on target.' And everything was great.

And then he turned to my partner and said, 'Well, Allan, you're a cancer survivor. You should take this new test called Galleri. It's a simple blood draw and you should take it.'

Allan looks at me and he says, 'Well, I'll take it if she takes it.'

And I'm like, 'Okay, I'll take it.' I mean, I had just gotten a gold star from the doctor saying I was in perfect health. So, I'm thinking, 'Yeah, no biggie. I'll support Allan on this.'

I received a call from my doctor. He asked me to come into the office. I went into his office and he showed me the results of the Galleri test, and it did show that there was a signal detected.

[Dr. Korolevich] The test can tell you where the signal comes from. It's a signal detected in the blood, and it tells you with about an 80% to 90% accuracy where the probable site of origin is.

We looked at the results, and it said colorectal origin. So he said it was just about time for another colonoscopy anyway, and he sent me to a gastroenterologist.

I got a call from the gastroenterologist and he said that I had a 5 cm mass in her ascending colon.

[Mary] For someone who had no symptoms, nothing on any blood draws, nothing on the CT scan, nothing, he was shocked. He was shocked that the tumor was that large.

[Dr. Korolevich] So, I had the appropriate procedure to remove the cancer, and it turned out to be stage II. Another opinion at a major cancer institute said it was caught early. You do not need chemotherapy. We were just going to do active surveillance.

It turned out to be a very good outcome because here I had a patient was asymptomatic, totally asymptomatic. The only thing that gave us any hint was the blood test.

[Mary] And I knew that catching this early, like Galleri caught it really early for me. And again, I lost very little. I just lost a few weeks after the surgery.

So, the only test that found that, besides a colonoscopy—the actual physically going in—was the Galleri test.

And that's significant. That's huge.

Based on a clinical study of people ages 50 to 79 around 1% are expected to receive a Cancer Signal Detected result, which includes a predicted Cancer Signal Origin. After diagnostic evaluation, around 62% of these people are expected to have a confirmed cancer diagnosis.

The overall sensitivity in study participants with liver/bile duct cancer was 93.5% (100% for stage I, 70.0% stage II, 100% stage III, 100% stage IV).

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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 healthcare 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 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.

The GRAIL 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. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes

Demonstrated performance across ~400,000 participants

NHS-Galleri and PATHFINDER 2 trial results

Cancer Signal Detected with a Cancer Signal Origin for colon

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