Manila Times Business
FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test
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
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Source: manilatimes.net
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