Large-scale lung cancer clinical study demonstrates accuracy and sensitivity of Fluxion’s ERASE-Seq liquid biopsy
356-patient concordance study confirms performance using head-to-head testing vs. droplet digital PCR
15 Jun 2021Fluxion Biosciences has announced the publication of a paper on ERASE-Seq™ liquid biopsy with molecular amplification pools (MAPs). The paper, ‘Sensitivity, specificity, and accuracy of a liquid biopsy approach utilizing molecular amplification pools’, is co-authored by researchers at Fluxion and the Hospices Civils de Lyon Cancer Institute. Data showed the ERASE-Seq/MAPs approach to have a 98.8% concordance to the benchmark droplet digital PCR (ddPCR) approaches.
Liquid biopsies offer the potential to improve treatment of cancer by providing affordable, non-invasive detection of actionable cancer mutations from a blood sample. However, the relative abundance of cancer DNA in blood is extremely low, limiting test sensitivity. Recent studies demonstrate good concordance between liquid biopsies when the cancer DNA exceeds 1% allele fraction (AF), but concordance falls off below 1% AF, where many variants are detected.
In this large-scale study, Fluxion's ERASE-Seq approach was compared directly to benchmark ddPCR tests for EGFR variants that represent treatable biomarkers or indicate the onset of drug resistance mutations. Patient blood samples were drawn and split between the tests, allowing a direct, blinded head-to-head comparison for both sensitivity and specificity. ERASE-Seq demonstrated excellent concordance in the allele fraction of 0.05%-1%, where other sequencing-based liquid biopsies have reduced performance.
Fluxion CEO, Jeff Jensen, explained "Although ERASE-Seq is a sequencing-based test, it provides levels of sensitivity normally only associated with droplet digital PCR (ddPCR), an analytical technique that is considered the gold standard for sensitivity. ERASE-Seq can test for thousands of variants in a single sample, where ddPCR is limited to only a few variants per test, which means ERASE-Seq can assay many more actionable markers in one test. This is one of the largest liquid biopsy concordance studies ever conducted, and we're excited to see that ERASE-Seq performs at this level."