At Fluxion, we’re passionate about delivering cell-based and cell-free solutions that facilitate the transformation of research discoveries into new ways to diagnose and treat patients. By characterizing molecular and cellular mechanisms of disease, Fluxion’s platforms help bridge the translational medicine gap, enabling rapid advances in disease research, drug discovery, and the development of diagnostic tests.
356-patient concordance study confirms performance using head-to-head testing vs. droplet digital PCR
Alameda, CA, June 16, 2021 - Fluxion Biosciences 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", published in Nature Scientific Reports on May 24, 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.
"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," Fluxion CEO Jeff Jensen explains.
Fluxion offers Spotlight™ liquid biopsy panels utilizing the ERASE-Seq variant caller, with panels available for pan-cancer, myeloid, TP53, and others. Additionally, ERASE-Seq is easily incorporated with custom-designed panels based on user-selected genomic targets.
About Fluxion Biosciences Fluxion's pioneering liquid biopsy technologies are used globally by leading cancer centers developing new tests for early cancer detection and patient monitoring. For more information about Fluxion Biosciences' liquid biopsy capabilities, visit https://liquidbiopsy.fluxionbio.com/.