{"entity":{"id":"paper-klimova-phased-seq-validation-oncotarget-2025","kind":"paper","name":"Analytical validation of a circulating tumor DNA assay using PhasED-Seq technology for detecting residual disease in B-cell malignancies","aka":[],"tldr":"The laboratory validation of Foresight's phased-variant blood test in lymphoma, which detected tumour DNA at below one part per million when given plenty of DNA.","summary":"Blank plasma assessed specificity and a limiting dilution of a contrived diffuse large B-cell lymphoma sample assessed sensitivity and precision. The false positive rate was 0.24 per cent and the background error rate 1.95 x 10^-8. The 95 per cent limit of detection with 120 ng of input DNA was 0.7 parts per million, with precision above 96 per cent. Against a single-nucleotide-variant method as reference, positive percent agreement was 90.62 per cent (95% CI 74.98 to 98.02) and negative percent agreement 77.78 per cent (52.73 to 93.59).","asOf":"2026-11-04","links":[{"label":"Klimova et al., Oncotarget 2025","url":"https://doi.org/10.18632/oncotarget.28719"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40353795/"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":["diagnostics"],"technologies":["mrd-testing","ctdna-lymphoma-monitoring"],"targets":[],"drugs":["foresight-clarity"],"companies":["foresight-diagnostics"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["oncotarget"],"dependsOn":[],"notes":[],"journal":"Oncotarget","year":2025,"doi":"10.18632/oncotarget.28719","pmid":"40353795","authors":"Klimova N, Close S, Kurtz DM, et al.","paperType":"methods","findings":["LOD95 0.7 parts per million at 120 ng input.","False positive rate 0.24%; background error rate 1.95E-08.","Positive percent agreement 90.62%, negative percent agreement 77.78% against an SNV-based comparator."],"whatItMeans":"Reading several mutations on one fragment pushes detection below one part per million in lymphoma, where such clustered mutations are common. It has not been shown in breast cancer, where they are rarer.","caveats":["B-cell malignancies only.","The limit was set at 120 ng of input, more than most blood draws give.","Company-authored."]},"route":"/key-papers/paper-klimova-phased-seq-validation-oncotarget-2025/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"ctdna-lymphoma-monitoring","kind":"technology","name":"ctDNA monitoring in lymphoma (PhasED-seq, clonoSEQ)","route":"/technologies/ctdna-lymphoma-monitoring/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"drug":[{"id":"foresight-clarity","kind":"drug","name":"Foresight CLARITY","route":"/drugs/foresight-clarity/"}],"company":[{"id":"foresight-diagnostics","kind":"company","name":"Foresight Diagnostics","route":"/companies/foresight-diagnostics/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"journal":[{"id":"oncotarget","kind":"journal","name":"Oncotarget","route":"/journals/oncotarget/"}]}}