Founded in 1976, Panion & BF Biotech Inc. is currently traded on Taiwan OTC Emerging Market and is the only dual GMP manufacturer in Taiwan. In its effort to achieve its goal of "Improving the health and quality of life for all mankind”, Panion & BF Biotech Inc. established the PBF Diagnostics in 2014 as the disease diagnosis business sector.
PBF Diagnostics consists of talented professionals in related fields and leads by Professor Ching Sui Yi, the holder of 10 US patent and inventor of 14 first-to-market diagnostic products. Through its kernel team and R&D platform, PBF Diagnostics endeavors to build up the key technologies for development the expertise and products for infection testing and personalized cancer diagnosis.
We are the first company in Taiwan to have a complete competency in RnD-to-product commercialization without outsourcing. With our commitment to serving worldwide customers easy accessible cost-effective rapid tests, we strive to set the model in the research, development and manufacturing of IVD products with quality, safety and value. Throughout these years, we have established and maintained a total assurance program. We produce under Standard Operating Procedures and are ISO 13485 certified.
Since 2015, our product portfolio is composed of a broad range of antigen detection tests for gastrointestinal and respiratory diseases based on immunochromatography assay. These tests, marketed under the brand of Vstrip are all CE marked and approved by Taiwan FDA (TFDA).
Large clinical studies in comparison with gold standard have been initiated in US and Taiwan for the preparation of US filing. In addition to test kits, custom test development and contract manufacturing are also important part of services we have been providing.