FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions’ SPOT-MAS 10 Multi-Cancer Screening Test

FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions’ SPOT-MAS 10 Multi-Cancer Screening Test 

SINGAPORE, 28 May 2026 — 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–omics 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 five common cancers — breast, lung, liver, colorectal and gastric cancers — as well as five aggressive, less common cancers that currently lack standard screening methods — ovarian, pancreatic, esophageal, endometrial and head & neck cancers. 

The FDA grants Breakthrough Device Designation to a limited set of 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. Breakthrough Device Designation is not FDA approval, clearance or marketing authorization. 

“Receiving FDA Breakthrough Device Designation for SPOT-MAS 10 is a defining milestone for Gene Solutions that validates the potential of our multi-omics approach to transform cancer care,” 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 Background  

SPOT-MAS has been developed through years of rigorous 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. 

Since then, SPOT-MAS has 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. 

Advancing Cancer Detection Through Multi-Omics Innovation  

SPOT-MAS 10 joins a select group of multi-cancer detection technologies that have received FDA Breakthrough Device Designation. The platform is built on a multi-omic approach— integrating genetics, epigenetics, and fragmentomics — together with AI-driven analysis, large-scale prospective validation, and growing real-world evidence. 

“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.” 

Addressing a Critical Global Need 

Cancer remains a major global health burden, with many aggressive cancers frequently diagnosed at late stages due to limited or unavailable screening options. SPOT-MAS 10 is designed to complement — not replace — existing guideline-recommended screening programs while expanding early detection opportunities for cancers that lack established screening pathways. 

“We remain deeply committed to the responsible advancement and implementation of SPOT-MAS 10.” said Ida Deleskog Lindstrom, Global Medical Affairs Director at Gene Solutions. “Through close collaboration with clinicians, regulators, and partners, we will continue generating high-quality evidence to support clinical utility and help address critical gaps in early cancer detection for diverse populations worldwide.”  

Global Momentum and U.S. Development Pathway 

SPOT-MAS is currently available through select hospitals and clinics across Asia, with availability varying by market. The company has also expanded its international footprint across markets including Brazil, Turkey and the Middle East. 

For the United States, the 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.  

“This Breakthrough Device Designation represents a key regulatory milestone that accelerates our U.S. development pathway,” said Keng-Hou Hsu, Chief Financial Officer of Gene Solutions. “It enables more structured engagement with the FDA and strengthens our position as we continue to execute on our commercialization plans with a strong emphasis on responsible evidence generation.” 

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. 

About SPOT-MAS 10 

SPOT-MAS 10 is Gene Solutions’ multi-omics blood test designed to detect cancer-associated signals from cell-free DNA in plasma. A positive result should be followed by physician-directed diagnostic evaluation based on the predicted tissue of origin. SPOT-MAS 10 does not replace guideline-recommended standard-of-care cancer screening tests. 

About Gene Solutions 

Gene Solutions is a global biotechnology company headquartered in Singapore with a mission to make advanced genomic solutions accessible and affordable. Leveraging multi-omics, NGS, and AI, the company offers a portfolio including multi–cancer early detection (SPOT-MAS) and comprehensive tumor profiling with ctDNA monitoring (K-TRACK, K-4CARE). Gene Solutions operates CAP-accredited NGS laboratories and has delivered millions of genetic tests worldwide since 2017. The company is committed to advancing these innovations to improve patient outcomes through earlier detection, more precise treatment guidance, and better monitoring across oncology and reproductive health. 

For more information, visit www.genesolutions.com and follow the company on LinkedIn and Facebook.