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A Vietnamese genetic testing company whose SPOT-MAS blood test for several cancers received US Breakthrough Device designation in 2026.
Gene Solutions, placed in Ho Chi Minh City by the UK NIHR systematic review and issuing releases through a Singapore entity, developed SPOT-MAS, a low-depth multimodal cell-free DNA test validated prospectively in 9,024 Vietnamese adults (K-DETEK). It announced FDA Breakthrough Device designation for SPOT-MAS 10 on 27 May 2026.
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.
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.
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED).
Shares cfDNA fragmentomics, Multi-cancer early detection (MCED), Liquid biopsy (ctDNA).
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