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Gene Solutions' low-cost blood test from Vietnam; in 9,024 people without symptoms about one in two hundred tested positive and four in ten of those had cancer.
In the prospective K-DETEK study (Nguyen et al., BMC Medicine 2025; NCT05227261) of 9,024 asymptomatic adults aged 40 or older at 75 Vietnamese hospitals, 43 (0.48%) tested positive and 17 had cancer: positive predictive value 39.53% (95% CI 26.37 to 54.42), tissue-of-origin accuracy 52.94%, sensitivity 70.83% (50.83 to 85.09) and specificity 99.71% over 12 months; no stage I figure is given. In the earlier case-control study (Nguyen et al., eLife 2023; 738 non-metastatic patients with five cancers, 1,550 controls) sensitivity was 72.4% at 97.0% specificity, 73.9% at stage I.
Gene Solutions announced FDA Breakthrough Device designation for SPOT-MAS 10, for ten cancers (breast, lung, liver, colorectal, gastric, ovarian, pancreatic, oesophageal, endometrial and head and neck) in asymptomatic adults aged 40 and over, on 27 May 2026, and says the test has been used in more than 100,000 people and that it targets US launch readiness in late 2026 (company statements). K-ACCELERATE (NCT06391749) tests it as a triage test in people with symptoms. No Vietnamese approval or price was found.
Targeted methylation and shallow whole-genome sequencing (about 0.55x) of cell-free DNA, reading methylation, fragment size, copy number and end motifs in one workflow, with a predicted tissue of origin.
1.SPOT-MAS slips into a pocket on its target.
FDA Breakthrough Device designation for SPOT-MAS 10 (company announcement) source
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A prospective screening result in a lower-middle-income country, with a positive predictive value similar to PATHFINDER's; the sensitivity rests on 24 cancers, and the test's tissue call was right about half the time.
High early-stage figures at a lower specificity than screening needs; in the prospective K-DETEK study the test was run at 99.7% specificity.
Query for this drug: (TITLE:"SPOT-MAS" OR ABSTRACT:"SPOT-MAS" OR TITLE:"Screening for the Presence Of Tumor by DNA Methylation And Size" OR ABSTRACT:"Screening for the Presence Of Tumor by DNA Methylation And Size" OR TITLE:"SPOT-MAS 10" OR ABSTRACT:"SPOT-MAS 10") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about SPOT-MAS, not a curated reading list.
Shares cfDNA fragmentomics, Cell-free DNA methylation tests, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares Cell-free DNA methylation tests, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares Cell-free DNA methylation tests, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
Shares Cell-free DNA methylation tests, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA) and the tags test, mced.
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