What evidence shows that miRNA is elevated at Stage I and Stage II specifically?

The clinical validation studies conducted by Yenos Analytical specifically enrolled newly-diagnosed Stage I and Stage II cancer patients — the standard approach to validating early-detection assays. The studies confirmed that miRNA overexpression above the 1.5× HL threshold was present in 81–97% of these early-stage cases (varying by marker). This matters because many cancer biomarkers only become detectably elevated in Stage III or IV disease, when treatment outcomes are significantly worse. The high sensitivity at Stage I/II is what differentiates the Yenos platform from competitors: Galleri (Grail) achieves only 16.8% sensitivity at Stage I, while miR-141 alone achieves 97.3% in Yenos validation.