People who don’t have cancer have a very low likelihood of receiving a Cancer Signal Detected test result with Galleri. Galleri has a false positive rate of just 0.4%— the lowest of any available MCED test ** — helping to minimize unnecessary procedures and exposure to radiation.^3,6

People who receive a Cancer Signal Detected test result with Galleri have a high likelihood of having cancer (positive predictive value of approximately 62%).^3,4,6

^{Galleri is a screening test and does not diagnose cancer. Diagnostic testing is needed to confirm cancer. The Galleri test does not detect a signal for all cancers and not all cancers can be detected in the blood. False positive and false negative results do occur.}

The Galleri test predicts a cancer signal of origin with more than 94.3% accuracy, guiding an efficient diagnostic work-up.^6,7,8

Galleri screening is a game changer for cancer detection, helping adults at elevated risk of cancer, such as those 50 and over, detect aggressive cancers earlier and giving them more control over their health.

Published in top-tier peer-reviewed journals such as the Lancet and Annals of Oncology, Galleri has been rigorously studied with demonstrated performance in case-controlled and interventional studies, as well as extensive real-world experience.

Based on case-controlled and interventional intended use studies:
Galleri’s ability to correctly identify individuals who actually have cancer (sensitivity) is over 70% for the 12 cancers responsible for two-thirds of U.S. cancer deaths.^3,4

DNA shedding is the natural process by which cells in the body shed small amounts of DNA into the bloodstream. Cancerous cells, if present in the body, also release DNA and so the blood may carry a mixture of DNA fragments from healthy and diseased or cancerous cells. To determine if each DNA fragment in the blood came from a cancerous cell or a healthy cell, we analyze methylation patterns.

Methylation is a natural process by which methyl groups are added to the DNA molecule. Methylation can change the activity of a DNA segment without changing the sequence by controlling which sections of DNA turn on or off. Typically, methylation turns genes “off” and demethylation turns genes “on.” GRAIL uses advanced machine learning algorithms and pattern recognition to “read” methylation patterns.

Using these two principles, the Galleri test has three scientific steps:

1. Extract and sequence the DNA fragments from the blood to “read” the methylation patterns (assay)
2. Determine if DNA fragments may have originated from cancerous cells (machine learning classifier)
3. If cancerous DNA fragments are identified, use pattern recognition to predict the organ associated with the DNA fragments (cancer signal origin prediction, or CSO).

Population-level paradigm shift. Routine use of Galleri alongside recommended screening could decrease late-stage cancer diagnoses and usher in a new era of proactive cancer detection.

Available now, by prescription only.

^{*Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 43% of lung cancer cases (based on the estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years)}

^{**Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.}

^{***The overall sensitivity in study participants with pancreatic cancer was 83.7% (61.9% for stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). 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 overall sensitivity in study participants with ovarian cancer was 83.1% (50.0% for stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV).[3]}