The CellsWay CTC test is a research tool for monitoring disease course and treatment response in diagnosed cancer patients. This article summarizes the serial-measurement logic and the RUO (research use only) boundaries.
Monitoring with Serial Measurements
- Longitudinal data: CTC counts and phenotypic change can be tracked with blood samples taken at defined intervals during treatment.
- Early response signal: changes in CTC counts can indicate treatment response before imaging.
- Resistance research: phenotypic shifts during treatment (e.g. changes in HER2 or PD-L1) generate research data on acquired resistance mechanisms.
- Results are delivered to your physician as a pathology report within approximately 2 weeks; interpretation is done with physician counseling.
RUO Boundaries — Important
- CellsWay panels are for research use only (RUO).
- They are not used to diagnose, select treatment or guide therapy.
- Active treatment decisions are made on the basis of standard diagnostic methods (imaging, tissue pathology, approved laboratory tests).
- The product does not hold an in vitro diagnostic (IVD) registration.
Applicability
- Can be applied to cancer patients who can give blood from a vein.
- Not applied in patients with hematological cancers (blood cancers).
- Not used for screening in healthy individuals.
Reporting and Communication
The report presents CTC counts, panel results (where available) and quality notes. Additional measurements (EMT panels, serial time points) can be planned within a research protocol; this scope is clarified with our medical affairs team.
Rx-only——処方箋制のスクリーニング検査. Galleri® は診断検査ではありません。陽性結果は癌の診断を意味せず、陰性結果は癌を除外するものではありません。本検査は、医師が推奨する定期的な癌スクリーニングの代わりになるものではありません。 Galleri® はすべての癌種を検出するものではありません。