An exclusive distribution agreement between Australian life science company Cellmid (ASX: CDY) and Immunodiagnostics Limited, Hong Kong (IMD) will beef up the company's response to the COVID-19 crisis.
The deal will see Cellmid acquire commercial quantities of two essential tests for Australia and New Zealand, including for laboratory based, quantitative Enzyme Linked Immunosorbent Assays (ELISA's) and a point of care test for COVID-19.
ELISA systems are essential in vaccine trials, used when monitoring the population after vaccine roll outs begin and, in tandem with point of care screening, in serological surveys.
The new agreement comes on the back of Cellmid having already secured two agreements to access point of care and laboratory COVID-19 testing devices. Cellmid shares skyrocketed in March on the back of the company announcing it had secured a supply agreement for a rapid diagnostic test for COVID-19.
However, this latest agreement provides Cellmid with access to the ELISA systems that can quantify the level and identify the type of antibodies against different COVID-19 antigens.
"The key advantage of the ELISA technology is that it can measure absolute levels of antibodies against different SARS-CoV-2 antigens," says Cellmid.
"In addition, ELISA's normally have lower level of detection limits compared to point of care devices increasing their accuracy."
The tests will be acquired from IMD, a spin off company from Hong Kong University, and is dedicated to the discovery, manufacture and distribution of in vitro diagnostics for chronic and infectious diseases.
Cellmid says IMD manufactures its tests in facilities in Taiwan and China, adhering to strict quality control and validation.
In addition to the ELISA's, Cellmid will acquire a high-quality point of care serology device that detects both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) specific to COVID-19, differentiating it from the viral spike protein detecting kits already accessed by Cellmid.
Evaluation of the tests done by IMD and Hong Kong University, using a dataset comprising 273 confirmed COVID-19 patients and 542 per-COVID-19 control samples, showed an IgG sensitivity of 96.1 per cent and specificity of 96.1 per cent, and an IgM sensitivity of 91 per cent and a specificity of 87.4 per cent.
The company will likely seek Therapeutic Goods Administration (TGA) approval for the point of care serology device, but because ELISA's are used for research only, and thus do not require TGA approval, Cellmid will initially seek regulatory approval and import permits for just a small selection of the ELISA devices.
Shares in Cellmid are up 10 per cent to $0.16 per share at 11:25am AEST.
Updated at 11:49am at 9 July 2020.