【Zhubei, Taiwan — November 18, 2025】 — S&T BioMed Co., Ltd. announced today that it has received official notification from Singapore’s Health Sciences Authority (HSA) that its innovative EarlyFound® MMP-1 Rapid Strip Test has been granted medical device market authorization. The product has been assigned registration number MDPR251118A0001.
This approval represents another significant regulatory milestone for the product, following its prior certification under the EU CE (IVDD) framework.
The EarlyFound® MMP-1 Rapid Strip Test is the world’s first saliva-based rapid test for oral cancer risk screening. By collecting a small sample of saliva and detecting the MMP-1 protein biomarker, the test provides a qualitative assessment of an individual’s potential risk of developing oral cancer. Its non-invasive, fast, and easy-to-use format makes it well-suited for broad population screening and expands accessibility to early detection.
Founded in December 2016 and based in the Zhubei Biomedical Park in Taiwan, S&T BioMed focuses on a proprietary non-invasive cancer detection platform, with a primary emphasis on innovative diagnostic solutions for oral cancer. The company has been actively pursuing global regulatory approvals to bring its technologies to international markets.
Current regulatory status of S&T BioMed’s oral cancer diagnostic products is as follows:
EarlyFound® MMP-1 ELISA Kit
Approved in: European Union CE (IVDD), Singapore, Australia, Hong Kong, Thailand, Vietnam
Under review in: Malaysia
EarlyFound® MMP-1 Rapid Strip Test
Approved in: European Union CE (IVDD), Singapore
Under review in: Australia, Thailand, Vietnam, Malaysia
S&T BioMed stated that it will continue expanding regulatory submissions and partnerships worldwide, aiming to make non-invasive early cancer detection more accessible to the public and advancing the mission of “making early detection easier.”
