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 for genomic alterations from whole exome sequencing
TYPEACCURACYSENSITIVITYSPECIFICITYLIMIT OF DETECTION
Single nucleotide variants (SNV)98.1%98.3%98.1%>20% purity
Insertions and deletions (INDELS)99.8%99.2%99.8%>20% purity
Copy number alterations >1 fold98.1%96.7%99.3%30% purity
Copy number alterations >2 fold96.9%97.1%96.9%>10% purity
Performance characteristics for TMB from whole exome sequencing
TYPEACCURACYPRECISION (CV)LIMIT OF DETECTION
Tumor mutational burden>98%<5%20% tumor purity
Performance characteristics for genomic alterations from whole transcriptome sequencing
TYPEACCURACYSENSITIVITYSPECIFICITYLIMIT OF DETECTION
1Expressed fusions are called from RNA-seq.
Fusions198%96%100%>5 junction reads
>7 sum of junction and spanning reads
>0.1 FFPM (fusion fragments per million)
Performance characteristics for gene expressions from whole transcriptome sequencing
TYPEACCURACYPRECISION (CV)LIMIT OF DETECTION
Gene expressions (RNA-seq)97%5%≥1.0 TPM (transcripts per million)

FFFE | 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 for gene expressions from whole transcriptome sequencing
TYPEACCURACYPRECISION (CV)LIMIT OF DETECTION
Gene expressions (RNA-SEQ)97%5%≥1.0 TPM (transcripts per million)