Gene Solutions, a Singapore-based biotechnology company focused on genomic tools for cancer detection, said on May 28 that the US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Spot-Mas 10, an AI-powered blood-based multi-cancer test.

In a press release first shared with Tech in Asia, the company said that Spot-Mas 10 is intended as an adjunctive screening test for asymptomatic adults aged 40 and older.

It analyzes plasma from a single venous blood draw for cancer-associated signals across 10 cancers.

Gene Solutions said the designation does not amount to FDA approval, clearance, or marketing authorization. However, it gives the company a priority channel to engage with the regulator as it advances US development and validation plans and targets a late-2026 US launch.

The test is currently available through select hospitals and clinics across Asia, with availability varying by market.

In a published prospective study of the earlier Spot-Mas platform involving 9,024 asymptomatic adults in Vietnam, researchers reported 70.83% sensitivity and 99.71% specificity.

Among 43 positive test results, 17 participants had malignant lesions, eight had precancerous lesions, and 18 had no malignant or precancerous lesions identified.

The platform was originally designed for five cancers but identified malignant lesions across 11 cancer types in that cohort.

🔗 Source: Gene Solutions