Distinção de ensaios de HRD (Myriad myChoice CDx vs FoundationOne CDx)
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| ID | BIO-HRD-ASSAY-DISTINCTION |
|---|---|
| Tipo | Biomarcador |
| Alegais | GIS versus LOH/TAI/LSTHRD assay distinctionHRD platform comparisonРозмежування HRD-аналізів (Myriad myChoice CDx vs FoundationOne CDx) |
| Estado | reviewed 2026-04-29 | pending_clinical_signoff |
| Doenças | Nenhuma declaração |
| Fontes | SRC-CIVIC SRC-NCCN-COLON-2025 |
Fatos de biomarcadores
| Tipo de biomarcador | composite_score |
|---|---|
| Medição | MétodoDuas plataformas de diagnóstico acompanhantes aprovadas pela FDA com diferentes sistemas de pontuação: (a) Myriad myChoice CDx — Genomic Instability Score (GIS) combinando LOH + TAI + LST como um único composto, limiar GIS >=42 para HRD-positivo; (b) FoundationOne CDx HRD — relata LOh-alto (>=16% LO HG) mais BRCA1/2 status; agrega LOOH apenas, sem TAI ou LST. Ambos executam em tumor FFPE. Unidadescategorical (HRD-positive | HRD-negative); platform-specific cut-points are not interchangeable |
| Biomarcadores relacionados | BIO-HRD-STATUS BIO-BRCA1-BRCA2-GERMLINE |
Notas
Scope: this entity is a methodological / assay-distinction layer on top of BIO-HRD-STATUS. The clinical concept (HRD as a PARPi-response predictor) lives in BIO-HRD-STATUS. This entity records the technical caveats clinicians need when interpreting an HRD report from a specific platform. **Why two assays diverge:** - **Myriad myChoice CDx (companion to olaparib + bevacizumab in PAOLA-1 and niraparib in NOVA / PRIMA):** - Composite Genomic Instability Score (GIS) = LOH + TAI + LST - Threshold: GIS >=42 OR BRCA1/2 mutation -> HRD-positive - Captures three independent genome-scarring footprints (LOH = loss of heterozygosity; TAI = telomeric allelic imbalance; LST = large-scale state transitions) - **FoundationOne CDx HRD (companion to rucaparib in ARIEL3 design; olaparib HRRm-positive subset):** - LOH-high threshold: %LOH >=16% across genome - Does NOT include TAI or LST - More permissive on some BRCA-wt high-grade serous tumors, stricter on others — discordance with myChoice runs ~10-20% in head-to-head series **Clinical implications of the discordance:** - A patient classified HRD-positive on one platform may be classified HRD-negative on the other; this is a known pre-analytic lim...
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