415P - Initial experience in a real-world Asian cohort with a circulating tumor DNA (ctDNA) mutation-based multi-cancer early detection (MCED) assay

Background

Blood-based MCED testing has emerged as a promising paradigm for earlier detection of cancer, which is associated with better outcomes. Little is known about the real-world performance of such assays in Asia. A ctDNA mutation-based MCED assay (LucenceINSIGHT), reports cancer signal (CS) status in plasma, and additionally predicts tissue-of-origin for up to 10 cancers where identifiable. We report here real-world results of the initial cohort.

Methods

Targeted ultrasensitive amplicon-based next-generation sequencing (NGS) with mirror barcodes is used to detect CS status by detecting cancer-associated mutations and viral DNA in 84 genes in plasma cell-free DNA (cfDNA). Matched white blood cell DNA was analyzed to exclude clonal hematopoiesis as a contributor. Consecutive results from 264 subjects (1/2023 - 6/2023) from Singapore, Hong Kong and Malaysia that underwent testing at a CAP-accredited, CLIA-certified laboratory were included in the analysis.

Results

were returned for 100% of subjects with a mean turnaround time of 14.1 calendar days. Mean age was 55.1 years (yrs) with 61.4% being male. CS-positive rate was 1.1% (3/264). All 3 CS-positive subjects were male, >40 years of age and were asymptomatic and without known cancer at screening. All 3 subsequently had neoplasms confirmed (locally advanced colon cancer, localized kidney cancer, and myeloproliferative neoplasm), for a specificity and PPV of 100%. 2 of 3 of these cases (kidney and myeloproliferative neoplasm) would not have been covered under traditional screening guidelines. One subject with CS-negative test results had a suspected cholangiocarcinoma at the point of test order, for an overall sensitivity of 75%.

Conclusions

We report initial experience with a cohort undergoing amplicon-based MCED testing in Asia, with a real-world CSD rate of 1.1%, consistent with previous ctDNA-based cancer screening studies in the USA. A majority of cases detected were not covered under traditional screening guidelines. These findings provide additional support for the use of ultrasensitive mutation-based assays for screening.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Lucence Diagnostics Pte Ltd.

Funding

Lucence Diagnostic Pte Ltd.

Disclosure

M. Pek, C. Hao, Z.Y. Wan, J. Poh, M. Tan: Financial Interests, Institutional, Full or part-time Employment: Lucence Diagnostics. M. Tan: Financial Interests, Institutional, Full or part-time Employment: Lucence Diagnostics; Financial Interests, Institutional, Stocks or ownership: Lucence Diagnostics. All other authors have declared no conflicts of interest.