Abstract 733P
Background
The increasing burden of cancer underscores the urgent need for enhanced research in cancer screening and early detection to improve patient survival. To address this, we developed a multi-cancer early detection (MCED) test, Screening for the Presence Of Tumor by Methylation And Size (SPOT-MAS). This test profiles various features in circulating tumor DNA to detect a cancer signal (CS) and predict the cancer signal origin (CSO). Clinical validation involving over 9,000 volunteers in the K-DETEK study (NCT05227261) suggests that SPOT-MAS holds potential as a screening method in Vietnam. However, additional data across diverse clinical contexts are required for effective implementation in medical practice. Here, we report real-world (RW) clinical experience with 10,577 tests conducted not only in Vietnam but also in other Southeast Asian countries.
Methods
This report includes tests returned from January to July 2024, excluding those from clinical studies, across Southeast Asia: Vietnam, Singapore, Malaysia, Thailand, Indonesia, and the Philippines. We analyzed the pre-test clinical characteristics and diagnostic work-up results of cases with positive test results.
Results
Tests were processed across six Southeast Asian countries. Among the 10,577 tests with returned results, the CS detection rate was 0.8% (81/10,577), with a higher rate in males (0.8% - 38/4,557) compared to females (0.7% - 43/6,020). These rates were comparable to the MCED test performance and cancer incidence data from GLOBOCAN. Through true positive cases, we reported three cases involving lethal cancers-endometrial cancer, lymphoma, and multiple myeloma-to illustrate the utility of SPOT-MAS in detecting cancers that lack standard-of-care (SOC) screening methods.
Conclusions
The RW experience with the MCED test was consistent with previous large-scale clinical studies. The test successfully detected a CS and predicted CSO, including in cancers without established SOC recommended screening. These results provide critical data highlighting the potential of SPOT-MAS test to complement current SOC screening programs, thereby enhancing the effectiveness of multi-cancer early detection in countries with varying resource availability.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Medical Genetics Institute.
Funding
Gene Solutions JSC.
Disclosure
All authors have declared no conflicts of interest.