|Target Patients||Clinical Significance||Validation Study||Technique Platform||Test Process|
Pathologic stage II CRC after radical resection
Identify stage II CRC patients with low, intermediate or high risk of CRC disease specific death, and can reliably stratify clinically relevant patient sub-populations with differential risks of tumour recurrence and may support choice of adjuvant therapy for these individuals.
ColoProg is a combination analysis of Ploidy and stroma-tumor fraction.
DNA content (ploidy) and stroma-tumour fraction were estimated using automated digital imaging systems and DNA was extracted from sections of formalin-fixed paraffin-embedded (FFPE) tissue for analysis of microsatellite instability (MSI). Samples were available from 2624 patients recruited to the QUASAR 2 trial and two large observational series (Gloucester, n=954; Oslo University Hospita,n=578). Finally stage II CRC N=1029. Resultant biomarkers were analyzed for prognostic impact using five-year cancer-specific survival (CSS) as the clinical endpoint.
Ploidy and stroma-tumour fraction were significantly prognostic in a multivariate model adjusted for age, adjuvant treatment, and pathological T-stage in stage II patients, and the combination of ploidy and stroma-tumour fraction was found to stratify these patients into three clinically useful groups; 5-year CSS 90% vs 83% vs 73% (hazard ratio [HR]=1.77 [95% CI 1.13-2.77] and HR=2.95 [95% CI 1.73-5.03], P<0.001).
DNA Ploidy Analysis
With the proprietary software, 核影TM grabber, capture, and classify 2000 nuclei of different cells. Finally automatically calculate 2000 nuclei DNA integrated optical density (IOD) and plot in a histogram.
核影TM - Digital cell pathology platform compose of two programs: 核影TM Grabber and核影TM Classifier
核影TM was developed by Institute For Cancer Genetics and Informatics in Oslo (ICGI). ColoProgTM which applied this technique was developed and validated by Oxford University and Oxford Cancer Biomarkers Ltd.,Co.(OCB). My-BioMed is the exclusive strategically partner of OCB in Great China.
Tumour-stroma Fraction Analysis
The tumour-stroma fraction was measured on the histological images using developed proprietary software and analysis methods which automatically segmenting tumour-stroma in HE-stained tissue sections.The cutoff value for low and high stroma was 50%, will be grouped into high interstitial group (>50%), low interstitial group (<=50%).