SINGAPORE, May 28, 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.
