The Shield MCD results report is not a part of the FDA approved Shield IVD and has not been cleared or approved by the FDA.
Provider acknowledges and understands that the MCD results report is only available as an opt-in coupled with a Shield test order for CRC screening.
Provider or provider’s staff agree to not promote or advertise MCD results report.
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sensitivity for advanced adenomas
sensitivity for high-grade dysplasia
negative predictive value*
* The probability that a negative test result is truly negative.6
Sensitivity based on stage at diagnosis7†
†Excludes 2 CRC stage unknown (1/2 detected)
‡Assumes 5 incompletely staged by AJCC malignant polyps are Stage 1 disease
AJCC=American Joint Committee on Cancer.
The Shield MCD results report is not a part of the FDA approved Shield IVD and has not been cleared or approved by the FDA.
| Tumor type | Sensitivity | Primary CSO Accuracy |
|---|---|---|
| Bladder | 62% | 75% |
| Breast | 45% | 97% |
| CRC | 83% | 88% |
| Esophageal/Gastric (Stomach) | 96% | 78% |
| Liver (Hepatocellular) | 94% | 60% |
| Lung | 67% | 95% |
| Ovarian | 70% | 100% |
| Pancreatic | 67% | 77% |
| Prostate | 21% | 92% |
Overall specificity across all cancers:
98.6%
CRC = colorectal cancer; CSO = cancer signal origin; MCD = multi-cancer detection.
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