HRD assay distinction (Myriad myChoice CDx vs FoundationOne CDx)
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| ID | BIO-HRD-ASSAY-DISTINCTION |
|---|---|
| Тип | Біомаркер |
| Синоніми | GIS vs LOH/TAI/LSTHRD assay distinctionHRD platform comparisonРозмежування HRD-аналізів (Myriad myChoice CDx vs FoundationOne CDx) |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-CIVIC SRC-NCCN-COLON-2025 |
Дані про біомаркер
| Тип біомаркера | composite_score |
|---|---|
| Вимірювання | MethodTwo FDA-approved companion diagnostic platforms with different scoring systems: (a) Myriad myChoice CDx — Genomic Instability Score (GIS) combining LOH + TAI + LST as a single composite, threshold GIS >=42 for HRD-positive; (b) FoundationOne CDx HRD — reports LOH-high (>=16% genomic LOH) plus BRCA1/2 status; aggregates LOH only, no TAI or LST. Both run on FFPE tumor. Unitscategorical (HRD-positive | HRD-negative); platform-specific cut-points are not interchangeable |
| Пов’язані біомаркери | BIO-HRD-STATUS BIO-BRCA1-BRCA2-GERMLINE |
Нотатки
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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