# Gene Solutions

Source: https://onco.cc/companies/gene-solutions/  
OnCo record `gene-solutions` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Company
- Last checked: 2026-10-29
- HQ: Ho Chi Minh City
- Type: diagnostics
- Website: https://genesolutions.vn/

## Sources

- FDA Breakthrough designation release (27 May 2026): https://www.biospace.com/press-releases/fda-breakthrough-device-designation-marks-major-milestone-for-gene-solutions-spot-mas-10-multi-cancer-screening-test

## Connected records

- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [cfDNA fragmentomics](https://onco.cc/technologies/fragmentomics/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- drugs: [SPOT-MAS](https://onco.cc/drugs/spot-mas/)
- trials: [K-ACCELERATE (SPOT-MAS in people with symptoms)](https://onco.cc/trials/k-accelerate/), [K-DETEK (SPOT-MAS in adults without symptoms, Vietnam)](https://onco.cc/trials/k-detek/)
- key papers: [Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization](https://onco.cc/key-papers/paper-spot-mas-elife-2023/), [Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults](https://onco.cc/key-papers/paper-spot-mas-k-detek-bmc-med-2025/)

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