Since the inception in November 2013, Biohit Healthcare (Hefei) has been committed to the R&D and application of in vitro diagnostic (IVD) devices and supporting instruments. We have obtained ISO 13485 Quality Management System certification and the Medical Device Production License. Biohit (Hefei) was evaluated as National High-tech Enterprise in 2017 and 2020. The factory covers 25,000 m2 with 200 fully automated production lines and a daily capacity of about 10 million tests.
Through independent innovation, our IVD technology for digestive diseases, represented by the serum gastric function test, has reached an international advanced level. In December 2018, the serum gastric function test was introduced in the Chinese Guidelines for Diagnosis and Treatment of Cancer by the Health Care Commission as the only method for gastric cancer screening, and the relevant diagnosis standards are also based on our products. Currently, our products have received 20 medical device certificates, among which the chemiluminescence and fluorescence immunochromatography kits for Gastrin-17 are both the first-in-class.
Since the outbreak of COVID-19 in early 2020, Biohit (Hefei) has proactively participated in combating the pandemic. Based on previous technology development in the IVD industry, we have developed a number of COVID-19 antigen and antibody tests. The antibody test has been granted EUA by the US-FDA and the antigen blood test is the first of its kind in the world. We also developed rapid antigen tests based on Colloidal Gold method and Fluorescence Immunochromatography. The Fluorescence test can deliver higher sensitivity when used with supporting analyzer. So far, our tests have been distributed to more than 50 countries and regions.