What Galleri Is
Galleri is a multi cancer early detection blood test that analyzes methylation patterns in cell-free DNA from tumors circulating in the bloodstream. When a cancer signal is detected, the report includes a “cancer signal origin” to help target diagnostic imaging and follow-up.
Why It Matters
Most cancer deaths come from cancers that lack routine screening. Adding Galleri to standard screening increased the number of screen-detected cancers in a large registrational study, with a positive predictive value of about 62 percent and accurate cancer-signal-origin guidance.
Who It’s For
Galleri is recommended for adults with elevated risk for cancer, such as those age 50 and older. It should be used in addition to regular, guideline-based screenings. It is not recommended for people who are pregnant, age 21 or younger, or undergoing active cancer treatment.
How It Works
- Quick blood draw.
- Lab analyzes methylation fingerprints of cfDNA.
- Result reports “Cancer Signal Detected” or “Not Detected.” If detected, the report lists the most likely origin to focus downstream diagnostics.
Turnaround time is typically about two weeks from lab receipt of the specimen
Frequently Asked Questions
No. It is a complement to standard screenings recommended by your healthcare provider.
We review the report, which includes a likely tissue of origin, then order focused diagnostic testing. A positive screening result is not a diagnosis by itself.
About two weeks from the time the lab receives your sample.
Sensitivity improves with stage and varies by tumor type. In published validation, sensitivity was lower for stage I and higher for stage IV; some low-shedding cancers are less likely to be detected.
As of now it has Breakthrough Device designation and is pursuing FDA review; it is available by prescription while outcomes data continue to accrue.
