Validation

FF | NGS ASSAY TECHNICAL SPECIFICATIONS

The depth of coverage is 150x for tumor and 100x for normal sample. The assay is analytically and clinically validated for tumor content of at least 20%, with performance characteristics shown below.Performance characteristics of somatic alteration detection (WES generated from FF samples)
ACCURACY SENSITIVITY SPECIFICITYLIMIT OF DETECTION
Single nucleotide variants (SNV)98.5%100.0%98.4%≥5% VAF and / or ≥20% purity
Insertions and deletions (INDELS)99.9%100.0%99.9%≥10% VAF and / or ≥20% purity
Copy number alterations >1 fold96.3%100.0%99.1%≥30% purity
Copy number alterations >2 fold99.1%100.0%99.1%>10% purity
Performance characteristics of MSI (WES generated from FF samples)
ACCURACYPRECISIONLIMIT OF DETECTION
Microsatellite instability status100%100%≥20% purity
Performance characteristics of fusion detection (RNAseq generated from FF samples)
ACCURACYSENSITIVITYSPECIFICITYLIMIT OF DETECTION
Fusions (PolyA)>99%96%>99%≥0.1 FFPM (fusion fragments per million)
Performance characteristics of gene expression evaluation (RNAseq generated from FF)
ACCURACYPRECISION (CV)LIMIT OF DETECTION
Gene expressions (PolyA)>99.6%5.06%≥ 1.0 TPM (transcripts per million)