HRD assay distinction (Myriad myChoice CDx vs FoundationOne CDx)
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | BIO-HRD-ASSAY-DISTINCTION |
|---|---|
| Type | Biomarqueur |
| Alias | GIS contre LOH/TAI/LSTHRD assay distinctionHRD platform comparisonРозмежування HRD-аналізів (Myriad myChoice CDx vs FoundationOne CDx) |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| Sources | SRC-CIVIC SRC-NCCN-COLON-2025 |
Données biomarqueurs
| Type de biomarqueur | composite_score |
|---|---|
| Mesure | MéthodeDeux plateformes de diagnostic complémentaires approuvées par la FDA et dotées de différents systèmes de notation : a) Myriad myChoice CDx — GIS combinant LOH + TAI + LST en tant que seul composite, seuil GIS >=42 pour HRD positif; b) FoundationOne CDx HRD — rapporte LOh-élevé (>=16% LO HG) plus statut BRCA1/2; agrégats LOOH seulement, pas de TAI ou LST. Unitéscategorical (HRD-positive | HRD-negative); platform-specific cut-points are not interchangeable |
| Biomarqueurs connexes | BIO-HRD-STATUS BIO-BRCA1-BRCA2-GERMLINE |
Notes
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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