The OverC® report contains the detection status of cancer-associated methylation signals, the comprehensive score, and — when a signal is detected — the tissue-of-origin prediction. This article compiles the result interpretation framework and safety notices.
Report Structure
- Signal status: "Cancer-Associated Methylation Signals: Detected / Not Detected".
- Comprehensive score: the cancer signal comprehensive score; the threshold is 0.5. Score ≥ 0.5 is accepted as "detected", < 0.5 as "not detected".
- Predicted origins: when a signal is detected, the organ(s) that may be the source among the six cancer types are listed in order of probability.
- Quality control: the report carries the sample quality-control results (DNA concentration, methylation signal density, signal purity etc.) as "Passed".
Interpretation Principles
- A positive result is not a diagnosis: the signal only shows that methylation marks associated with the six cancer types originate from the sample. Even if the signals are considered most likely to originate from one organ, other organs cannot be ruled out.
- A negative result does not eliminate risk: no test achieves 100% accuracy; false negative results are possible.
- Next steps: on a positive signal, immediate physician evaluation; diagnostic tests (targeted imaging, endoscopy etc.) and comprehensive review with an authorized specialist are planned where needed.
Safety Notices and Limitations
- OverC® is not capable of detecting all cancer types and does not replace guideline-recommended standard cancer screening methods.
- False positive and false negative results may occur; non-cancerous conditions such as chronic inflammation or organ damage can also produce abnormal methylation signals.
- Due to insufficient cfDNA yield from the plasma sample, approximately 4.6% of samples may not be evaluable.
- Results may only be evaluated by a medical professional; test results cannot be considered definitive grounds for a clinical diagnosis.
- Test results are valid only for the sample submitted.
Report Communication
The reporting timeline varies with the shipping schedule; please contact our counseling team for the exact duration. Results are delivered with physician counseling; if a signal is detected, the diagnostic work-up and genetic counseling processes are managed where needed.
Rx-only — скрининговый тест по рецепту. Galleri® не является диагностическим тестом. Положительный результат не означает диагноз рака; отрицательный результат не исключает рак. Тест не заменяет регулярный скрининг рака, рекомендованный вашим врачом. Galleri® не обнаруживает все виды рака.