Proteomics International Laboratories has notched a significant milestone in its drive to commercialise PromarkerD, its ground-breaking blood test that can predict diabetic kidney disease.
The Perth-based company worked with a French specialist contractor Biotem to produce a pilot batch of key components for PromarkerD.
This successful technology transfer will help accelerate the worldwide rollout of PromarkerD, as well as the commercialisation of our pipeline of novel diagnostics.
Dr Lipscombe says Proteomics is building a robust manufacturing framework that could be applied to the company’s other diagnostics under development, including tests for endometriosis and asthma.
The components for the PromarkerD pilot batch were manufactured by Biotem, a specialist supplier of antibodies and immunoassays and are sufficient to test more than 50,000 people.
The pilot batch opens the door for large-scale manufacture and global distribution of PromarkerD that already has the tick of regulatory approval in the European Union, a significant potential market.
In Australia, a decision on regulatory approval is pending.
Proteomics says the successful pilot means prospective partners and licensees can have confidence PromarkerD can be manufactured in high volumes and to international regulatory standards.
Proteomics and Biotem already have the necessary certifications to allow Proteomics to extend its regulatory approvals across additional jurisdictions.
Biotem was contracted last August by Proteomics to manufacture the immunoassay kit version of PromarkerD.
The pilot batch was produced primarily for quality control and regulatory testing. However, some components are expected to form inventory for initial sales.
Based on a simple blood test, PromarkerD identifies a unique “fingerprint” of protein biomarkers in the blood using specialist reagents or antibodies developed by Proteomics and produced by UK-based global life science company Abcam.
It’s the world’s first predictive test for diabetic kidney disease and can predict the onset of diabetic kidney disease up to four years in advance.
A study revealed recently that PromarkerD also has the potential to predict late-stage renal decline, a condition where the kidneys lose their ability to remove waste and rebalance fluids.
Type 2 diabetes, for which PromarkerD is based, accounts for about 85 per cent of all diabetes. One-third of Type 2 diabetes sufferers have chronic kidney problems, the leading cause of end-stage renal disease.
International Diabetes Federation has estimated one in 11 adults has diabetes and the number is expected to grow to one in 10 by 2040.
By then, the federation estimates diabetes-related health expenditure will exceed US$802 billion.
Such numbers would appeal to any company in the medical sector and the market appears to be doing the maths. Proteomics’ shares jumped more than 8 per cent during intraday trading.
Is your ASX-listed company doing something interesting? Contact: firstname.lastname@example.org