Proteomics International has contracted French immunoassay specialist Biotem to manufacture test kits for the PromarkerD predictive test for diabetic kidney disease.
Biotem is an ISO 13485-certified company, which 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. ELISAs are the most commonly used laboratory technique for detecting biomarkers in the blood.
After engaging Abcam as the reagent producer, contracting Biotem, a respected global manufacturer, for the kit production was the last remaining foundation block required to complete the Northern Hemisphere manufacturing capability for PromarkerD. The manufacture of the PromarkerD kits to the ISO 13485 standard also enables Proteomics International to extend its regulatory approvals across additional jurisdictions. Prospective partners and licensees can now have confidence that PromarkerD can be manufactured in high volumes and to international regulatory standards.