A Cancer Signal Detected with a predicted origin of liver

Cancer Signal Detected with a Cancer Signal Origin of Bile Duct Cancer

"I’m happy to be alive. I’m happy to be here." - Melissa

Melissa's Experience with the Galleri test

[Melissa] My name is Melissa, and this is my story with Galleri.

I’m married and have two children. As a family, we love being outdoors—golfing, paddle boarding, and enjoying just about any outdoor activity together.

My physician has always been an advocate for proactive health screenings. I stay current with my annual mammograms and colonoscopies as directed, and my doctor also introduced us to the Galleri cancer screening test, which screens for more than 50 types of cancer.

We have some family history of cancer, so for me, I try to be very proactive.

My husband, Keith, and I have taken the Galleri test twice. The first time, everything came back clear for both of us. The second time I took the test, I was surprised to learn that a cancer signal had been detected.

What stood out to me about the Galleri test was that it identified a predicted cancer signal origin. In my case, it pointed to the liver and bile duct.

I was surprised because I had just completed my physical. I had no symptoms. I didn’t feel sick. All of my bloodwork came back perfect. There was no other indication that something might be wrong.

Because I wanted to be proactive, I had a CT scan. The results came back clear, but the Galleri result still weighed on my mind. I decided to keep looking for answers and scheduled an MRI.

That MRI found a tumor about an inch in size on my liver. A biopsy later confirmed it was cholangiocarcinoma, also known as bile duct cancer.

“ With this particular type of cancer, it’s very hard to detect, and most people don’t find out about it until it’s too late. ”

I received my Galleri results in mid-October, and I had surgery on December 6. My cancer was detected at the earliest possible stage. It had not spread anywhere else in my body.

Many of the physicians were amazed. We’ve never seen bile duct cancer at stage one.

One doctor told me, “As unlucky as it is that you have bile duct cancer, you might be the luckiest person I know.”

That experience showed me how important it is to continue screening regularly. Don’t just do it once and assume you’re safe. I took the first test and everything was clear—but what if I hadn’t taken the second one? What if I had waited a few more years?

I don’t know how long the cancer would have continued to grow.

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 of Bile Duct Cancer

Important Safety Information

Laboratory/Test Information

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