ViraxClear Receives ISP Approval for ViraxClear Rapid Test Kit Distribution to Chile With Signed LOI for up to 3 million Test Kits - Seite 2

Alex Somjen, CEO of Global Care Capital Inc., stated, “This distribution deal represents the culmination of months of negotiating by ViraxClear with top distributors in key global regions. Biosonda is in a perfect position to roll out mass testing for the region with Chile already seeing 288,000 confirmed cases of COVID-19 and the population requiring Antibody Testing once the curve has flattened.”

ISP Approval

The Chilean government require medical testing devices to receive ISP Approval before they can be sold in Chile. Both Innovita and Vazyme, ViraxClear suppliers, are now on the list of ISP Approved factories, allowing ViraxClear tests to be imported and sold nationally.

Established in 2006, Innovita is a Chinese high-tech enterprise specialized in R&D, manufacturing, marketing and after-sales service of In-vitro diagnostic tests. The CE and NMPA (formerly known as CFDA) approved Innovita serology tests have performed particularly well during preliminary clinical tests carried out by the COVID-19 Testing Project; a multidisciplinary team of researchers and physicians at UCSF, UC Berkeley, Chan Zuckerberg Biohub and Innovative Genetics Institute. According to their studies, Innovita tests scored a 96.3 % specificity (NPV); 83.3% Sensitivity (PPV) with an IN-HOUSE ELISA test (gold reference standard) giving 99.1 % specificity (NPV); 81.8 % Sensitivity (PPV): https://covidtestingproject.org/

Vazyme, which is a highly reputable producer of enzymes and antibodies with products covering clinical diagnosis, molecular diagnostics, high-throughput sequencing and life science research, as well as RNA sequencing, enabling customers and reagent manufacturers to get enzymes with higher resistance. Vazyme owns a dedicated 8000 m2 R&D site and have established the Biotechnology Industry Research Institute, which is comprised of a team of nearly 100 scientists.

The Test Kits are intended for the qualitative detection of IgG and IgM antibodies against 2019 Novel Coronavirus, produced by the immune system after virus infection. IgM is the earliest antibody that appears upon the first immune response, with detection indicating an early stage infection. IgG is produced later and lasts a long time in the body, indicating a prior infection. The combination of the two markers offers an insight into what stage the virus has reached.