Cellmid signs exclusive distribution agreement for SARS-CoV-2 laboratory tests

Cellmid Limited (ASX:CDY) has signed an exclusive distribution agreement with Immunodiagnostics Limited (IMD) Hong Kong for laboratory-based, quantitative Enzyme Linked Immunosorbent Assays (ELISAs) and a point of care serology test for SARS-CoV-2 for Australia and New Zealand. While ELISA’s used for research only do not require TGA approvals, Cellmid will initially seek regulatory approval from the TGA as well as import permits for a small selection of the devices, based on their immediate utility, with others to follow based on demand. Providing TGA regulatory approval is received, the company will order commercial quantities of the tests. ELISA technology The key advantage of the ELISA technology is that it can measure absolute levels of antibodies against different SARS-CoV-2 antigens. In addition, ELISA’s normally have lower level of detection limits compared to point of care devices, increasing their accuracy. Routinely used in most laboratories, ELISA systems are essential in vaccine trials, when monitoring the population after vaccine roll-outs begin and, in tandem with point of care screening, in serological surveys. The agreement Cellmid already has two agreements in place to access point of care and laboratory-based SARS-CoV-2 testing devices. The agreement with IMD provides the company with access to laboratory-based ELISA systems that can quantify the level and identify the type of antibodies against different SARS-CoV-2 antigens. An initial exclusivity period runs for six months from the date of signing the agreement with subsequent time extensions negotiated by mutual agreement thereafter. ELISA kit product The first product Cellmid will focus on is the CE Marked SARS-CoV-2 S1 IgG ELISA Kit for the detection of IgG antibody specific for viral spike protein. This agreement also covers additional ELISA tests including the SARS-CoV-2 NP IgM ELISA Kit, SARS-CoV-2 NP IgG ELISA Kit, SARS-CoV-2 NP total Antibody ELISA Kit and SARS-CoV-2 S1RBD IgG ELISA Kit1. The suite of available tests has broad utility in different research and clinical scenarios, allowing Cellmid to address various market needs. Control samples Evaluation of the kit by the manufacturer and by Hong Kong University State Key Laboratory of Biotechnology using a stratified dataset comprising 273 confirmed COVID-19 patients and 542 pre-COVID-19 control samples showed specificity of 99.08% and sensitivities of: Day 0-7: 94.03% (n=67) Day 8-14: 96.20% (n=79) Day 14+: 100% (n=127) Samples for the evaluations were sourced from the Centre for Disease Control at Dongguan City and Shenzhen Sixth People’s Hospital in Shenzhen. Point of care test In addition to the ELISA’s, a high-quality point of care serology device is also included in the agreement. The device detects both IgM and IgG specific to the nucleocapsid protein of SARS-CoV-2, differentiating it from the viral spike protein detecting kits already accessed by Cellmid. Cellmid is likely to seek regulatory approval from the TGA for the device. Evaluation of the point of care test by the manufacturer and by Hong Kong University State Key Laboratory of Biotechnology using a stratified dataset comprising 273 confirmed COVID-19 patients and 542 pre-COVID-19 control samples showed an IgG sensitivity of 96.1% and specificity of 96.1% at the most relevant period of 14+ days following onset of symptoms and an IgM sensitivity of 91% and specificity of 97.4% at the most relevant period of 0-7 days from symptoms. Samples for the evaluations were sourced from the Centre for Disease Control at Dongguan City and Shenzhen Sixth People’s Hospital in Shenzhen.