2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.092 Mahami Roychowdhury-Saha Abstract

PP01.092 Mahami Roychowdhury-Saha Abstract

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A study was conducted to assess the analytical performance of a blood-based, cell-free DNA (cfDNA) targeted methylation sequencing test for recurrence assessment in early-stage lung adenocarcinoma (LUAD). The test aims at identifying patients at high risk of recurrence, enabling early intervention and improved outcomes.<br /><br />The study analyzed cfDNA samples from 100 healthy donors and 7 individuals with early-stage LUAD. The limit of detection with 95% probability (LoD95) was determined as the lowest tumor methylated fraction (TMeF) at which circulating tumor DNA (ctDNA) could be detected. The LoD95 was found to be 0.0044% TMeF. Specificity of the test, measured as the percentage of samples with ctDNA not detected among 62 unique healthy donor samples, was 96.9%. Precision, determined by concordance with expected ctDNA detection in replicates, was 98% for positive samples and 100% for negative samples.<br /><br />The test showed accurate classification across a range of cfDNA inputs from 2 to 75 ng and was not affected by common endogenous interferents. Additionally, the stability of whole blood in Streck tubes for sample shipping was characterized under both summer and winter conditions.<br /><br />The results demonstrate the robust analytical performance of the cfDNA-based targeted methylation sequencing test for recurrence assessment in early LUAD. Further studies are needed to evaluate the clinical utility of ctDNA detection for recurrence assessment in early-stage LUAD.<br /><br />Overall, this study validates the effectiveness and accuracy of the blood-based cfDNA targeted methylation sequencing test as a potential tool for early detection and risk assessment in lung adenocarcinoma.

Keywords

cfDNA

targeted methylation sequencing test

recurrence assessment

LUAD

early intervention

tumor methylated fraction

ctDNA

specificity

precision

analytical performance