On February 8, 2023, Beroni Group Limited (OTCQX: BNIGF; NSX: BTG) (“Beroni”), an Australia-based biopharmaceutical enterprise, announced that its enhanced COVID-19 Antigen Rapid Test Kit – Colloidal Gold Method has been undergoing clinical trial in China, for eventual application to the National Medical Product Administration (NMPA) for marketing authorisation in the country.
In response to the rapid spread of the COVID-19 Omicron strain which is more contagious but less severe, Beroni Group further optimised its COVID-19 Antigen Rapid Test Kit and started the clinical trial of the Rapid Test Kit in March 2022, in collaboration with Tianjin Haihe Hospital, Tianjin Hospital of ITCWM Nankai Hospital and the Second Hospital of Tianjin Medical University. As of December 2022, 276 subjects (100 negative subjects, 176 positive subjects) were enrolled and tested. The test results of 229 subjects in the first group (100 negative subjects, 129 positive subjects) showed that the positive coincidence rate was 86.57%, the negative coincidence rate was 88.89%, and the total coincidence rate was 88.21%, which performed better than many others in the industry. At present, the research team is sorting out the relevant data of the second group of subjects to apply for marketing authorization in China.
“The COVID-19 pandemic is developing and we may coexist with the virus for a long time. Rapid test kits that can be used at home will become essential products for our daily health surveillance. China is a highly dynamic market in the world with huge market potential. Beroni’s COVID-19 Antigen Rapid Test Kit is expected to become a key product for SARS-CoV-2 antigen detection in China’s market. Beroni Group always emphasizes on product quality and excellent customer service , and we strive to provide customers with fast, accurate, easy-to-operate products” said Jacky Zhang, CEO of Beroni Group.