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Advancing cancer screening with a clinically-validated blood test

The Galleri test is supported by clinical studies with over 20,000 participants

PATHFINDER
CCGA3

Lancet: A prospective study of a multi-cancer early detection (MCED) blood test

Cohort: 6,600+ adults ages 50-79 without clinical suspicion of cancer, and with and without additional cancer risk factors from 7 US sites—intended use population.
Study design: Prospective, interventional, return-of-results study to evaluate the clinical implementation of an MCED test.
Study objectives: Assess the extent of diagnostic testing required to achieve diagnostic resolution, evaluate test performance, and evaluate participant reported outcomes.
Key outcomes: When MCED was added to recommended single-cancer screening tests the number of cancers detected approximately doubled. Median time to diagnostic resolution was 79 days (shorter for true positive; longer for false positive). High accuracy of predicted Cancer Signal Origin enabled targeted diagnostic evaluations. Most diagnostic evaluations involved imaging. Key performance metrics were validated and MCED screening was safely implemented. The results from the PATHFINDER study support feasibility of broad screening use of Galleri.

Annals of Oncology: Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set

Cohort: 4,000+ participants without a prior history of cancer from 142 sites, 70% with newly diagnosed cancer, 30% cancer free at enrollment and at 1 year.
Study design: Case-controlled observational study to validate an MCED test regarding sensitivity, specificity and Cancer Signal Origin prediction.
Study objectives: Validate an MCED test version further refined for use as a screening tool.
Key outcomes: The Galleri test demonstrated high specificity with a low false positive rate, sensitivity that varied by cancer class and increased with increasing cancer stage, high accuracy of CSO prediction and detected a cancer signal across a wide diversity of cancers and cancer stages. Results from the CCGA3 study support the feasibility of use in addition to recommended single-cancer screening tests.

Galleri sets the standard for multi-cancer early detection

To achieve the benefits of early detection while minimizing harms, multi-cancer early detection requires low false positive rates, highly accurate localization of organ/tissue origin, and high sensitivity of the deadliest cancer types.

Screen for more

Galleri detects a signal shared by more than 50 cancer types1 with a single blood draw, most of which lack routine screening tests. In a clinical study, Galleri approximately doubled the number of cancers detected than recommended screening.2 In the same study, 48% of confirmed cancers that were detected by Galleri were in stages I-II.2 The Galleri goes beyond routine cancer screenings (breast, lung, colon, cervical, and prostate) to screen for many cancers.

99.5% Specificity

Galleri has a specificity of 99.5%, which means that it has a low false positive rate of 0.5%. A low false positive rate helps minimize unnecessary diagnostic procedures.

Specificity = The proportion of people without cancer who received "No Cancer Signal Detected" results.

43.1% Positive Predictive Value

The Galleri’s positive predictive value (PPV) is 43.1%, meaning that about 4 out of 10 individuals with a Cancer Signal Detected result are expected to have a confirmed cancer diagnosis following diagnostic workup. Galleri’s PPV helps healthcare providers set expectations when discussing appropriate next steps for diagnostic workup.

Positive Predictive Value = The proportion of people with Cancer Signal Detected results diagnosed with cancer

98.5% Negative Predictive Value

The negative predictive value (NPV) for Galleri is 98.5%, which provides confidence that a No Cancer Signal Detected result is likely a true negative.

Negative Predictive Value = The proportion of people with No Cancer Signal Detected results without cancer.

93.4% Cancer Signal Origin Accuracy

The Galleri test’s highly accurate Cancer Signal Origin (CSO) prediction is an essential feature of multi-cancer early detection test. It helps clinicians effectively direct a diagnostic evaluation after a Cancer Signal Detection result.

Cancer Signal Origin Accuracy = The proportion of correctly predicted first (or second) CSO prediction(s) among study participants with cancer and "Cancer Signal Detected" results.

CSO Reported	What Is Included
Anus	Anus
Bladder, Urothelial Tract	Bladder, Renal Pelvis, Urether, Urethra
Bone and Soft Tissue	Skeletal Muscle and other Connective Tissue, Vascular Tissue, Bone and Cartilage
Cervix	Cervix
Colon, Rectum	Colon, Rectum, Appendix
Head and Neck	Oropharynx, Hypopharynx, Nasopharynx, Larynx, Lip and Oral Cavity (including Oral Tongue), Nasal Cavity, Paranasal Sinuses, Major Salivary Glands
Hematopoietic and Lymphoid Organs	Bone Marrow, Primary and Secondary Lymphoid Tissue (Lymph Nodes, Extranodal Lymphoid Tissue, Spleen, Thymus)
Kidney (excluding renal pelvis)	Kidney
Liver, Bile Duct	Liver, Intrahepatic Bile Duct
Lung	Lung, Bronchus
Melanocyte-containing Tissues/ Skin	Melanocyte-containing Tissues (Skin, Uvea and Muscosal Tissue)
Ovary	Ovary, Fallopian Tube, Primary Peritoneum
Pancreas, Gallbladder	Pancreas, Extrahepatic Bile Duct, Gallbladder
Prostate	Prostate
Stomach, Esophagus	Stomach, Esophagus
Thyroid	Thyroid
Uterus	Uterus

Cancer Classes	Sensitivity, proportion of true positives
Liver/Bile-duct	93.5%
Head and Neck	85.7%
Esophagus	85.0%
Pancreas	83.7%
Ovary	83.1%
Colon/Rectum	82.0%
Anus	81.8%
Cervix	80.0%
Urothelial Tract	80.0%
Lung	74.8%
Plasma Cell Neoplasm	72.3%
Gallbladder	70.6%
Stomach	66.7%
Sarcoma	60.0%
Lymphoma	56.3%
Other	50.8%
Melanoma	46.2%
Lymphoid Leukemia	41.2%
Bladder	34.8%
Breast	30.5%
Uterus	28.0%
Myeloid Neoplasm	20.0%
Kidney	18.2%
Prostate	11.2%
Thyroid	0.0%

76.3% sensitivity for 12 deadly cancers

Galleri has high sensitivity (76.3%) for 12 of the deadliest cancers* that comprise two-thirds of all cancer deaths.1,7 Higher sensitivity for the deadliest cancers helps minimize overdiagnosis and/or overtreatment of indolent cancers.1 More aggressive cancers, such as pancreatic cancer, tend to release more cell-free DNA into the bloodstream at early stages and are more likely to be detected by the Galleri test.1,3 The overall sensitivity for cancer detection is 51.5% for all cancers and across all stages. This provides the opportunity to detect many additional cancers when added to recommended single-cancer screening.

Sensitivity = The proportion of people with cancer who received "Cancer Signal Detected" results.

*Anus, bladder, colon/rectum, esophagus, head and neck, liver/ bile duct, lung, lymphoma, ovary, pancreas, plasma cell neoplasm, and stomach

Ongoing clinical evidence program backed by 380,000+ participants

The GRAIL clinical evidence program includes more than 380,000 participants in completed or ongoing studies. To support and validate our technology, studies are being performed at leading health systems and community and academic medical centers in the US and United Kingdom.

The Galleri test collabtoration with leading cancer research institutes

Real world experience with over 200,000 Galleri tests completed

.9%

of test results were Cancer Signal Detected, consistent with clinical studies

68%

of Cancer Signal Detected results had predicted Cancer Signal Origins representing cancers without guideline-recommended screening options