{"entity":{"id":"gene-solutions","kind":"company","name":"Gene Solutions","aka":[],"tldr":"A Vietnamese genetic testing company whose SPOT-MAS blood test for several cancers received US Breakthrough Device designation in 2026.","summary":"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.","asOf":"2026-10-29","links":[{"label":"FDA Breakthrough designation release (27 May 2026)","url":"https://www.biospace.com/press-releases/fda-breakthrough-device-designation-marks-major-milestone-for-gene-solutions-spot-mas-10-multi-cancer-screening-test"}],"tags":[],"related":[],"cancers":[],"sections":["early-detection","diagnostics"],"technologies":["mced","liquid-biopsy","fragmentomics"],"targets":[],"drugs":["spot-mas"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["k-detek","k-accelerate"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hq":"Ho Chi Minh City","country":"VN","companyType":"diagnostics","website":"https://genesolutions.vn/","investors":[],"funding":[]},"route":"/companies/gene-solutions/","neighbours":{"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"fragmentomics","kind":"technology","name":"cfDNA fragmentomics","route":"/technologies/fragmentomics/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"spot-mas","kind":"drug","name":"SPOT-MAS","route":"/drugs/spot-mas/"}],"trial":[{"id":"k-accelerate","kind":"trial","name":"K-ACCELERATE (SPOT-MAS in people with symptoms)","route":"/trials/k-accelerate/"},{"id":"k-detek","kind":"trial","name":"K-DETEK (SPOT-MAS in adults without symptoms, Vietnam)","route":"/trials/k-detek/"}],"paper":[{"id":"paper-spot-mas-elife-2023","kind":"paper","name":"Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization","route":"/key-papers/paper-spot-mas-elife-2023/"},{"id":"paper-spot-mas-k-detek-bmc-med-2025","kind":"paper","name":"Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults","route":"/key-papers/paper-spot-mas-k-detek-bmc-med-2025/"}]}}