Reason about drug repurposing strategies in HCLS — choosing between target-based and phenotype-based approaches, evaluating mechanism-of-action overlap, querying drug-gene interaction databases, assessing clinical translatability, and ranking candidates by evidence strength. Use when the user asks to repurpose a drug…
Reason about germline and somatic variant classification using ACMG/AMP 2015 and AMP/ASCO/CAP frameworks. Use when the user asks to classify a variant, interpret a VCF annotation, resolve a VUS, apply ACMG criteria, weigh ClinVar evidence, evaluate gnomAD allele frequencies, interpret REVEL/CADD/SpliceAI scores…
Reason about SaMD (Software as a Medical Device) regulatory compliance for FDA, EU MDR, and global submissions. Use when the user asks about IEC 62304 safety classification, ISO 14971 risk management, 21 CFR 820/QMSR quality system requirements, Design History File structure, 510(k)/De Novo/PMA pathway selection…