The SafeSEQ NSCLC panel is a clinical grade, ultra-sensitive liquid biopsy solution for the identification of gene mutations, shown in the table below, associated with Non-Small Cell Lung Cancer (NSCLC).
The SafeSEQ NSCLC assay demonstrates ultra-sensitive detection of low-frequency mutations, with a calling threshold of 5 MM (0.025% MAF for 20,000 GE DNA input), while specificity remains very high. Similar to other SafeSEQ platform configurations, 95% concordance has been observed with the OncoBEAM assay for the detection of EGFR and KRAS mutations (≥0.1% MAF).
SafeSEQ sensitivity has 99.2% agreement with OncoBeam™
R2 = 0.9709
The SafeSEQ NSCLC panel delivers equivalent performance with broader genomic coverage than testing with OncoBEAM™ digital PCR (dPCR). SafeSEQ technology demonstrates ultra-sensitive detection of low-frequency mutations, with a calling threshold of 5 mutant molecules (0.025% mutant allele frequency [MAF]) from whole blood. Concordance analysis of SafeSEQ and OncoBEAM results demonstrated an overall percent agreement of 99.6% for detection of mutations in EGFR, KRAS, and BRAF (>0.1% MAF) as seen in the figure above.