Cancer Signal Detected with a Cancer Signal Origin of colon/rectum
“Because we found it at stage three, I feel very confident that I will be able to live and see all of that and enjoy my family.” - Kara
Read the story below or watch the video here.
Kara’s Story with the Galleri test
[Kara] My name is Kara and this is my story with Galleri.
A few years ago, my husband and I both became more interested in taking care of our own health so that we could be around for our kids and have energy and be healthy for them.
[Kara’s husband] We've got a great family doctor who just is honest all the time about being healthy.
She's incredibly good about preventative health.
[Dr. Barreto] I actually read about the Galleri tests in a newsletter. It completely blew me away.
The signs of it really blew me away that you're able to screen with one simple, convenient blood draw.
[Kara] So I went to the laboratory and they did a simple blood draw there.
It was quick and easy, and they told me that I would receive the results soon.
[Dr. Barreto] When I received Kara’s test, I was very surprised.
The test showed that a cancer signal had been detected.
The cell of origin was deemed to be the colon.
[Kara] My doctor said that we needed to do a colonoscopy.
I went in for the colonoscopy, and the doctor that performed it didn't think he was going to find anything.
Afterwards, he came into the room and he was in shock that he had found a four centimeter tumor in my colon.
And by the end of the day, we had the results that the CT scan had confirmed the cancer in the colon.
[Dr. Barreto] She was completely asymptomatic.
Kara is a healthy, vibrant mom.
[Kara] I was concerned that it was already at stage three, but I was very glad that we caught it before it got to stage four.
I felt like if it was already stage four, I don't know if I would live to see my children grow up and get married and have kids of their own.
Because we found it at stage three, I feel very confident that I will be able to live and see all of that and enjoy my family.
[Kara’s husband] This has been a hard season, but it's been a season of gratitude because she's alive.
There's been wonderful people around us.
One of the things I really lean in on, though, is a sense of gratitude for the Galleri test, for this technology.
I am incredibly grateful that my wife is alive.
We would not have known that she had cancer without this.
[Kara] Sharing my story is one way that that this journey won't be a waste if it helps somebody else.
Based on a clinical study of people ages 50 to 79 around 1% are expected to receive a cancer signal detected result which includes predicted cancer signal origins. After diagnostic evaluation, around 62% of these people are expected to have a confirmed cancer diagnosis.
The overall sensitivity in study participants with colon/rectal cancer was 82.0% (43.3% for stage I, 85.0% stage II, 87.9% stage III, 95.3% 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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