Cancer Signal Detected with a Cancer Signal Origin of plasma cell neoplasm
“If somebody was hesitant about taking the test, I think the first thing I would tell them is it's so simple — it's just a blood test.” - Cindy
Cindy’s Experience with the Galleri test
[Cindy] My name is Cindy and this is my story with Galleri
I like to walk the river. I live along the riverfront and spend a lot of time looking at the wildlife on the river.
So I have been seeing Dr. Westgate, my OB-GYN, for a number of years. She knows that I have a BRCA1 gene, and so she suggested I take the Galleri test, also due to family history, which is not great.
[Dr. Westgate] Hi, my name is Dr. Candice Westgate. I'm an OB-GYN, and I am passionate about cancer prevention and early detection. I'm now the medical director of the AHEAD Program — Adventist Health Early All-Round Cancer Detection Program — helping patients and our providers stay ahead of cancer.
I was introduced to the Galleri test and my mind was blown — the amazing opportunity that we have here to screen one individual for multiple cancers with something as simple as a blood draw.
[Cindy] When she first mentioned taking the test, I have to admit I was a little reticent because no one wants to find out they have cancer.
After taking the Galleri test, about two weeks later Dr. Westgate called. Well, her office called and said they'd like to schedule an appointment. She reviewed the Galleri results with me and it showed Cancer Signal Detected.
You just don't expect it. Again, I felt fine. I didn't have any symptoms, and it was just kind of a shock.
[Dr. Westgate] She came to see me for her test results and I was able to discuss with her and show her that she did in fact have a Cancer Signal Detected. The test also shows us where that cancer signal of origin is coming from, and for her it showed that it was in the plasma cell lineage.
[Cindy] When she gave me the results, she said she wanted me to see Dr. Kang, an oncologist.
[Dr. Kang] My name is Tyler Kang. I'm a medical director in medical oncology. Multi-cancer early detection tests should be added to routine cancer screening, and that's what we're doing here at Adventist Health.
Indeed, what her diagnosis is, called multiple myeloma. It is a cancer of the blood cells, specifically abnormal plasma cells in the bone marrow.
She was actually quite asymptomatic, so we picked up her diagnosis before she developed any symptoms of her myeloma.
Patients in earlier stages have an overall better prognosis. As soon as we made the diagnosis of multiple myeloma and completed her staging, we immediately started her on myeloma therapy.
[Cindy] I started having to go to the infusion center up at Santolina Hospital to get my treatments.
When I was diagnosed I was asymptomatic, and I just remember walking in there and those people are very, very sick — and I wasn't.
[Dr. Kang] We were able to basically put her into a state of remission. Her myeloma had actually gone away.
In oncology, obviously there are a lot of advances. We need to really be able to offer the most cutting-edge therapies, diagnostics, and treatment for our patients.
I think the efficacy of it and the fact that it can pick up a cancer signal at an earlier stage is a good thing.
This is a small rural community, really, and the fact that we have a comprehensive cancer program here is a real benefit to our local population. If there are tests that can be easily obtained and potentially used for the general population, that would be very helpful.
[Dr. Westgate] I had a wonderful support system in my back pocket — not just from the resources that were supplied and offered to me by the Galleri team, but also by my local oncologists. We knew that we were starting this program together, and as a combined unit, or a circle of care, we would be taking care of this patient.
[Cindy] I wish that something like the Galleri test had been available for my mom, who had lung cancer.
If somebody was hesitant about taking the test, I think the first thing I would tell them is it's so simple — it's just a blood test.
If it comes back and there's nothing there, great — lucky you. But if it comes back and there is a signal, well you can jump on it.
[Dr. Westgate] With multiple myeloma, the majority of individuals present in the emergency room in kidney failure or with a pathogenic fracture. Cindy never had to undergo any of those morbidities associated with this diagnosis.
[Cindy] It's hard to quantify what difference Galleri has made for me.
Don't be hesitant. It's a simple blood test.
I'd like to say thank you.
I feel I could have had a very different outcome.
[Dr. Kang] To people who are skeptical, this is what I would say about Galleri: it is a powerful test that can help detect a cancer signal.
The future with multi-cancer early detection tests looks like it will help make it easier to screen our patients for cancers. A simple blood test can be done to find cancers.
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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