Update: 9 May 2023 -- This fine print was in their email to me today:
Quoting: Red text added for emphasis.
Laboratory / test information |
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GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. |
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Disclaimer: I am not a medical person. I just wanted to know how this technology to detect 50 types of cancers by using blood samples works. It was showcased to Firefighters at their large conference. Read on below about the Firefighters. Read several of the studies about this technology -- all are very technical and full of medical wording. This one seems to explain it -- looking for cancer signals in the blood when cancer was not detected in tissue samples. Recall: a very invasive biopsy is required for detecting Non-Hodgkin Lymphoma.
This is a lung cancer study but the technology works across 50 cancers. Cancers give off a DNA product into the blood stream that now can be detected is the Big Deal -- this is called liquid biopsy research.
https://www.annalsofoncology.org/article/S0923-7534(19)31127-5/fulltext
Quoting:
"Background
Noninvasive genotyping using plasma cell-free DNA (cfDNA) has the potential to obviate the need for some invasive biopsies in cancer patients while also elucidating disease heterogeneity. We sought to develop an ultra-deep plasma next-generation sequencing (NGS) assay for patients with non-small-cell lung cancers (NSCLC) that could detect targetable oncogenic drivers and resistance mutations in patients where tissue biopsy failed to identify an actionable alteration".
What is cell-free DNA?
https://www.thermofisher.com/blog/behindthebench/what-is-cell-free-dna-cfdna-seq-it-out-19/ Quote: "Cell-free DNA (or cfDNA) refers to all non-encapsulated DNA in the blood stream. A portion of that cell-free DNA originates from a tumor clone and is called circulating tumor DNA (or ctDNA)."
Another article easier to understand: https://www.mdanderson.org/cancerwise/liquid-biopsies--understanding-ctdna-and-circulating-tumor-cells.h00-159463212.html
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Missileers concerned about Cancer: Here is a real breakthrough in early cancer detection to include Lymphoma (Hodgkin and Non-Hodgkin):
"FDIC International is North America's Leading Firefighter Conference"
The largest Fire Fighter Conference is completing 29 April 2023 in Indianapolis.
https://www.fdic.com/welcome
The National Firefighter Cancer Registry is now up and running and includes military firefighters and is being highlighted at this conference. https://www.cdc.gov/niosh/firefighters/registry.html
A Breakthrough Technology is being showcased by one of the vendors attending:
Quoting:
The Galleri test is a multicancer early detection test that detects a common cancer signal across more than 50 types of cancer through a simple blood draw.
https://www.galleri.com/patient/the-galleri-test/types-of-cancer-detected
Quoting:
The Galleri® multi-cancer early detection test is the first product from GRAIL whose mission is to detect cancer early. The Galleri test complements guideline-recommended screenings, and can detect a cancer signal across more than 50 types of cancer through a routine blood draw.
Using the power of next-generation DNA sequencing, population-scale clinical studies, and state-of-the-art computer and data science to overcome one of medicine’s greatest challenges, GRAIL is focused on saving lives and improving health by pioneering new technologies for early cancer detection.
https://events.clarionevents.com/fdic2023/Public/eBooth.aspx?IndexInList=21&FromPage=Exhibitors.aspx&ParentBoothID=&ListByBooth=true&BoothID=884994
The Test: https://www.galleri.com/patient/the-galleri-test
Video. -- "How Does the Galleri Test Work?": https://www.youtube.com/watch?v=ZqkuKb9yqVA&t=3s
The Cost: https://www.galleri.com/patient/the-galleri-test/cost
See File attached for research centers involved in studying this product.