SafeSEQ Panel

NSCLC

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 panel is a clinical grade, ultra-sensitive liquid biopsy solution for the identification of gene mutations associated with Non-Small Cell Lung Cancer (NSCLC). The table shows genes, gene regions covered (amino acids), and clinical relevance.

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™

This chart measures SafeSEQ sensitivity and shows that SafeSEQ has a 0.97%  agreement with OncoBEAMTM for mutant allele frequency (MAF). The SafeSEQ Breast Cancer Panel can detect clinically relevant mutations in circulating tumor DNA (ctDNA) from patients with metastatic breast cancer with sensitivity equivalent to the Sysmex highly clinically validated OncoBEAM liquid biopsy Breast Cancer Panel, which detects gene mutations in PIK3CA, AKT1, and ESR1 with a limit of detection 0.04% mutant allele frequency (MAF). The robust accuracy at low allelic frequencies observed for SafeSEQ in this study demonstrates the advantages of highly focused panels for defined clinical intended uses.

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.

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