Postoperative colorectal cohort.
Evidence
Commercial experience meets published evidence
forming the foundation for international development
VitaGuard combines a functioning workflow and commercial operating experience with published colorectal evidence. Fidelion’s international programme focuses on defined laboratories, populations and intended uses.
Established operating experience
Commercial experience provides a foundation
for building confidence in new markets
Fidelion's search led to VitaGuard, a functioning laboratory-developed testing workflow with commercial operating experience.
With international rights outside Greater China assigned, Fidelion's programme covers operational implementation and validation for new laboratories, populations and intended uses.
Published colorectal evidence · 2024
In the reported cohort, longitudinal MRD
was associated with recurrence
Reported recurrence outcome under the study’s longitudinal analysis.
Reported association between longitudinal MRD status and recurrence.
These figures apply only to the published observational cohort and should not be generalised to other populations or to Fidelion’s international implementation.
Already in practice
Commercial use and an established laboratory workflow provide a substantive starting point.
Evidence with a history
Published studies suggest longitudinal ctDNA monitoring may add meaningful context after treatment.
Confidence for new markets
Fidelion intends to establish performance for each population, setting and intended use.
Published research
What the studies show
across defined clinical cohorts
Published studies offer a credible foundation for investigation. They do not establish international product performance or clinical utility.
Risk association and earlier detection
A 2024 observational analysis followed 104 patients with stage I–IV colorectal cancer. It reported 94.4% longitudinal negative predictive value and a 9.385 hazard ratio for the association between longitudinal MRD status and recurrence. Postoperative MRD detected 14 of 18 observed recurrences; in 12 of those 14, detection preceded CT confirmation, with a reported median lead time of 198.5 days.
Clearance associated with response
A 2025 biomarker analysis used 244 plasma samples from 79 patients within a multicentre phase III trial. ctDNA negativity or lower ctDNA after radiotherapy, and ctDNA/MRD clearance after short-course radiotherapy, were associated with pathological complete response.
How the studies relate to the platform
The studies have direct Tongshu author, panel or technical-support connections, but neither independently validates the complete current VitaGuard configuration. The 104-patient paper does not name the VitaGuard brand; the 79-patient analysis used a Tongshu ZhenXinan panel and notes sample-size, follow-up and modelling limitations.
These studies report associations and earlier molecular detection in defined cohorts. They do not establish that earlier detection improves treatment outcomes, and their results should not be generalized to every patient, cancer type, workflow or intended use.
International evidence programme
Building clinical confidence
market by market
Reproducible analytical performance under intended-use laboratory conditions.
Clinical performance for each cancer type, population and setting.
Prospective validation of reporting and longitudinal interpretation.
Evidence that distinguishes earlier molecular detection from improved patient outcomes.