- Cellmid (CDY) has signed a distribution agreement with Immunodiagnostics (IMD) for Enzyme Linked Immunosorbent Assays (ELISA’s) and SARS-CoV-2 tests in Australia and New Zealand
- In addition to ELISA, a high-quality point of care serology device is included in the agreement
- IMD is a subsidiary of Hong Kong University and is focused on developing in vitro diagnostics for chronic and infectious diseases
- Cellmid will initially seek Therapeutic Goods Administration (TGA) approval as well as import permits for a small selection of the ELISA kit devices
- The agreement has an exclusive period of six months from the commencement date
- The main advantage of the ELISA technology is that it can accurately measure levels of antibodies against different SARS-CoV-2 antigens
- The first product Cellmid will focus on is the CE Marked SARS-CoV-2 S1 IgG ELISA Kit, however, the agreement covers a suite of ELISA products
- Company shares have dropped 3.33 per cent to trade for 14.5 cents each
Cellmid (CDY) has signed a distribution agreement with Immunodiagnostics (IMD) for Enzyme Linked Immunosorbent Assays (ELISA’s) and SARS-CoV-2 tests in Australia and New Zealand.
IMD is a spin-off company of Hong Kong University and is led by Professor Aimin Xu. It is committed to the discovery, development and distribution of in vitro diagnostics for chronic and infectious diseases.
IMD codevelops tests, like those for SARS-CoV-2, with Toronto Bioscience Incorporated who also acts as the North American distributor for the tests.
Cellmid will initially seek regulatory approval from the Therapeutic Goods Administration (TGA) as well as import permits for a small selection of the ELISA kit devices and others will follow by demand.
The company will order commercial quantities of the tests once regulatory approval has been given.
The exclusive period of the agreement lasts for six months after the agreement has been signed.
The agreement with IMD gives Cellmid access to lab-based ELISA systems that can quantify the level and identify the type of antibodies against different SARS-CoV-2 antigens.
The main advantage of the ELISA technology is that it can accurately measure levels of antibodies against different SARS-CoV-2 antigens. ELISA’s usually have a lower level of detection limits compared to point of care devices which increases accuracy.
ELISA systems are standardly used in most labs for vaccine trials, when monitoring the population after the rollout of vaccines, alongside point of care screening and in serological surveys.
The first product Cellmid will focus on is the CE Marked SARS-CoV-2 S1 IgG ELISA Kit to detect the IgG antibody specific for viral spike protein.
Evaluation of the kit using a dataset of 273 confirmed COVID-19 patients and 542 pre-COVID-19 control samples showed a specificity of 99.08 per cent and sensitivities of 94.03 per cent in days zero to seven, 96.20 per cent in days eight to 14, and 100 per cent from day 14 and thereafter.
Samples for these evaluations came from the Centre for Disease Control at Dongguan City and Shenzhen Sixth People’s Hospital in Shenzhen.
The agreement also covers additional ELISA tests and the suite of tests has ‘broad utility’ in different research and clinical scenarios, which allows the company to target different market needs.
In addition to ELISA, a high-quality point of care serology device is included in the agreement. The device detects both IgM and IgG specific to the nucleocapsid protein of SARS-CoV-2. Cellmid expects to seek TGA approval for the device.
Company shares have dropped 3.33 per cent to trade for 14.5 cents each at 3:47 pm AEST.