A Cancer Signal Detected with a predicted origin of liver

Cancer Signal Detected with a Cancer Signal Origin for gallbladder

"I'm going to be able to live my life because we found it so soon." - Valerie

Valerie’s Experience with the Galleri test

[Valerie] My name is Valerie and I am very active and I was really fascinated with just being healthy and living a long time and spending as much time as I can with my granddaughter.

I really didn't have any concerns with my health.

I was reading a book and it mentioned the Galleri test and they mentioned that it checks for cancers and it was a simple blood test and I thought that's genius. I think I want to take that test.

I had a simple blood draw and then the lab sent the test to GRAIL.

So I received a call and they explained that there was a signal detected and that I needed to take this information to my doctor and my doctor ordered the MRIs very quickly for me.

The radiologist said, "I've never seen a gallbladder with so many stones." He said, "That needs to come out."

The surgeon had called the day after I had that surgery and let us know that the pathology report came back and that there was a 4 1/2 cm tumor in my gallbladder.

My surgeon has taken out about 1,500 gallbladders. He said mine was the third one that he's seen that had cancer.

And now we've moved forward with my care plan and I'm on chemotherapy right now for 6 months.

“ So I feel like this test was made for me and I appreciate it so much and there's just nothing I can say for myself and my family that could say thank you enough. ”

I'm going to be able to live my life because we found it so soon, so thank you.

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).

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

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Demonstrated performance across ~400,000 participants

NHS-Galleri and PATHFINDER 2 trial results

Cancer Signal Detected with a Cancer Signal Origin for gallbladder

Valerie’s Experience with the Galleri test

Important Safety Information

Laboratory/Test Information

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