FDA Grants Breakthrough Device Status to Gene Solutions' SPOT-MAS 10 Cancer Screening Test

Gene Solutions has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its SPOT-MAS 10 multi-cancer screening test, announced in a press release.

SPOT-MAS 10 is a blood test that analyzes circulating cell-free DNA methylation and fragmentomic patterns using a machine learning algorithm to detect cancer-associated signals. It is intended for use as an adjunctive screening tool for asymptomatic adults aged 40 and older, covering cancers such as breast, lung, liver, colorectal, gastric, ovarian, pancreatic, esophageal, endometrial, and head and neck cancers.

The FDA Breakthrough Device Designation provides Gene Solutions with prioritized engagement as it advances its U.S. development and validation plans. The company aims for U.S. launch readiness in late 2026, supported by ongoing laboratory and validation work.

SPOT-MAS 10 builds on research and clinical development that included a large prospective cohort study of more than 9,000 participants, which demonstrated high specificity and consistent performance. The test has been used in over 100,000 individuals in clinical practice and integrates genetics, epigenetics, and fragmentomics with AI-based analysis to support early cancer detection.