Proteomics International Laboratories (ASX:PIQ) has announced it has contracted French immunoassay specialist Biotem to manufacture test kits for the PromarkerD predictive test for diabetic kidney disease.
The company said the agreement will see Biotem manufacture Proteomics International’s immunoassay kit version of PromarkerD. This kit identifies a unique 'fingerprint' of protein biomarkers in the blood using specialist reagents (antibodies) developed by Proteomics International and produced by Abcam.
Proteomics said Biotem is an ISO 13485-certified company. It has produced specialised immuno-technology products for more than 40 years.
Biotem’s core competency is in immunoassay production covering ELISA (enzyme-linked immunosorbent assay) and also LFIA (lateral flow immunoassay) technology.
"Working with Abcam, Proteomics International also recently produced recombinant versions of the antibodies, which are more stable than those produced from classical hybridoma cells," said the company.
Proteomics International's managing director Dr Richard Lipscombe said engaging Biotem and Abcam were key elements in achieving the company’s goal of selling a test with full regulatory approvals at scale worldwide.
“Currently, the PromarkerD immunoassay (ELISA) kits are manufactured under licence in Australia,” he said. “Now, by contracting these specialist manufacturers we are building our production capacity to meet our anticipated demand for the test in the Northern Hemisphere and worldwide.”
The term of the manufacturing agreement is three years and Proteomics International has the option to extend for additional periods of one year. Biotem will manufacture PromarkerD test kits on a fee-for-service basis. The agreement is non-exclusive and both parties have the right to terminate the agreement with immediate effect upon the breach of any material terms of the agreement. The agreement is also subject to the standard terms, conditions, and warranties typical of a contract of this type.
The company said after engaging Abcam as the reagent producer, contracting Biotem for the kit production was the last remaining foundation block required to complete the Northern Hemisphere manufacturing capability for PromarkerD.
Dr Lipscombe said Proteomics International was building a robust manufacturing framework that could be applied to the Company’s other diagnostics under development, including tests being developed in relation to endometriosis and asthma.
“The engagement of global manufacturing partners will help accelerate the worldwide roll-out of PromarkerD, as well as the commercialisation of our pipeline of other diagnostics under development,” he said.