A blood-based multi-cancer early detection (MCED) test demonstrated the ability to accurately identify multiple cancer types in routine clinical practice in six Asian countries, according to the results of a large, real-world study. The Screening for the Presence of Tumor by Methylation and Size (SPOT-MAS) test even included detection for cancers for which no standard screening program currently exists.

The MCED test showed high specificity and strong predictive performance in testing asymptomatic individuals for cancers in Vietnam, Thailand, Indonesia, the Philippines, Malaysia, and Singapore. Findings from the real-world study, presented in a press briefing ahead of the 2026 ASCO Breakthrough Meeting (Abstract 14), indicate that MCED testing could help address major screening gaps in low- and middle-income countries, particularly for cancers that are prevalent in Asia but lack established population-based screening programs.

In May 2026, the U.S. Food and Drug Administrated granted a Breakthrough Device designation to the SPOT-MAS 10 blood test.

Study Details

The retrospective analysis evaluated commercial SPOT-MAS testing performed in routine clinical settings among 84,145 people without cancer-related symptoms. SPOT-MAS uses a multilayered analysis of circulating tumor DNA, incorporating methylomics, fragmentomics, copy number alterations, and end-motif profiling, combined with machine-learning algorithms to identify cancer signals. The assay is designed to detect 10 cancer types, including the five most common cancers in the Asia-Pacific region as well as five aggressive malignancies.

According to lead investigator Dang Luu Hong Nguyen, MD, of the Medical Genetics Institute in Ho Chi Minh City, Vietnam, the study may provide the first large-scale real-world evidence from Asia supporting clinical utility of SPOT-MAS as a complementary screening strategy, particularly in low- and middle-income countries lacking accessible national screening programs. Researchers noted that the cancer landscape in Asia differs substantially from that of Western populations, with cancers such as liver, gastric, and nasopharyngeal carcinoma occurring at higher rates.

For the current analysis, investigators focused on 22,597 participants who had completed at least 12 months of follow-up and underwent appropriate diagnostic evaluation after testing. Individuals with positive MCED results were referred for physician assessment and confirmatory diagnostic procedures, including imaging studies and tissue biopsies. The study population was predominantly Vietnamese, female, and relatively low risk, with most participants reporting no heavy smoking, alcohol use, hepatitis B or C infection, or family history of cancer. The median age was 46 years.

Key Findings

Among the evaluable participants, 94 individuals (0.4%) received a positive SPOT-MAS result. Diagnostic workup confirmed precancerous or cancerous lesions in 64 of those individuals, yielding a positive predictive value of 68.1%. Thirty participants were ultimately determined to have false-positive results. The assay correctly identified the tissue or organ of origin in nearly 80% of confirmed cases, helping direct subsequent diagnostic investigations. Of the confirmed cancers detected, 20 involved stomach, liver, or nasopharyngeal cancers—tumor types that currently lack routine screening programs.

Of 22,503 individuals who tested negative, follow-up confirmed that 99.51% were true negatives, whereas 17 participants were subsequently found to have precancerous or cancerous lesions, representing false-negative results. Overall, SPOT-MAS achieved a sensitivity of 79.0% and a specificity of 99.9%, with a negative predictive value of 99.9%. Investigators noted that these findings closely mirrored results previously observed in the prospective K-DETEK trial, supporting the reproducibility of the assay outside of a controlled research environment and suggesting it may be practical for routine clinical implementation.

The investigators plan to continue monitoring participants beyond 12 months to determine whether additional cancers emerge after longer follow-up and to further assess the test’s real-world performance.

DISCLOSURES: This study was funded by Gene Solutions, which developed the SPOT-MAS test. The study authors reported no financial relationships.

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