FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test
SINGAPORE, May 27, 2026 /PRNewswire/ -- Gene Solutions, a global biotechnology company advancing accessible genomic solutions for cancer detection and precision oncology, today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to SPOT-MAS 10, its multi-omic blood test designed to detect cancer-associated signals.
The proposed indications for use describe SPOT-MAS 10 as a qualitative in vitro diagnostic test performed on plasma derived from a single direct-draw venous whole blood specimen. The test analyzes circulating cell-free DNA methylation and fragmentomic signatures using a machine-learning-based algorithm to detect a cancer-associated signal. It is intended for use as an adjunctive screening test in asymptomatic adults aged 40 years and older to assist in the detection of cancers within the scope of the assay, including breast, lung, liver, colorectal, gastric, ovarian, pancreatic, esophageal, endometrial and head & neck cancers.
The FDA grants Breakthrough Device Designation to certain qualifying devices that have the potential to provide for more effective diagnosis of life-threatening or irreversibly debilitating diseases, such as cancer, than current options.
"Receiving FDA Breakthrough Device Designation for SPOT-MAS 10 is a defining milestone for Gene Solutions and reflects the potential of our multi-omic approach in cancer screening," said Dr. Nguyen Hoai Nghia, CEO & Co-founder of Gene Solutions. "This recognition strengthens our commitment to advancing accessible, evidence-based technologies that support earlier detection of cancers, especially for those where screening options remain limited — ultimately helping to improve patient outcomes worldwide."
SPOT-MAS has been developed through years of scientific research and clinical development. In March 2025, SPOT-MAS became the first multi-cancer early detection blood test in Asia to complete a large prospective cohort validation. Results from the K-DETEK study, published in BMC Medicine, evaluated SPOT-MAS in more than 9,000 asymptomatic participants and demonstrated strong performance, including high specificity and the ability to identify cancer-associated signals across multiple cancer types.
SPOT-MAS has since been used in more than 100,000 individuals in real-world practice, with consistent performance observed beyond controlled study settings. Real-world data were presented at ESMO Asia 2025 and will be featured at ASCO Breakthrough 2026 in Singapore.
The SPOT-MAS platform is built on a multi-omic approach integrating genetics, epigenetics and fragmentomics, together with AI-driven analysis, prospective validation and real-world evidence. SPOT-MAS 10 is designed to complement — not replace — existing guideline-recommended screening programs while expanding screening opportunities for cancers that lack established screening pathways.
"Early cancer detection requires more than identifying a single molecular signal," said Dr. Le Son Tran, Principal Investigator of SPOT-MAS. "By integrating multiple layers of cell-free DNA information with machine learning, SPOT-MAS is designed to extract deeper biological signals from blood while maintaining the high specificity required for responsible screening."
For the United States, Breakthrough Device Designation provides Gene Solutions with a prioritized channel of engagement with the FDA as the company advances its U.S. development and validation plans. Gene Solutions is targeting U.S. launch readiness in late 2026, supported by its ongoing U.S. laboratory and validation strategy.
Looking ahead, Gene Solutions will continue to collaborate with clinicians, regulators and global partners to generate evidence supporting the responsible implementation of SPOT-MAS 10 and its role in addressing unmet needs in cancer screening.
Important Regulatory Notice: SPOT-MAS 10 has received U.S. FDA Breakthrough Device Designation. Breakthrough Device Designation is not FDA approval, clearance or marketing authorization. The device remains subject to applicable FDA regulatory review requirements, and the designation does not guarantee future FDA approval, clearance or authorization.
For more information, visit www.genesolutions.com.
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