Medical technology company Proteomics International Laboratories (ASX: PIQ) has hatched plans to distribute the first commercial batches of its new “PromarkerD” immunoassay kits, with first shipments scheduled for 20 November 2018.
“This follows completion of production of the key antibody reagents in Puerto Rico, and manufacture of the kit in certified facilities in California, both instigated in partnership with licence partner Omics Global Solutions,” the company said.
Today’s news follows positive performance verification results which Proteomics presented at the recent Diabetes Technology summit held in North Bethesda, Maryland.
The medical technology company says it is at the forefront of “predictive diagnostics” and bioanalytical services and specialises in the area of “proteomics” – the industrial scale study of the structure and function of proteins.
The company received the world’s first ISO 17025 laboratory accreditation for proteomics services and operates from state-of-the-art facilities located on Perth’s QEII Medical Campus.
Results presented at the 18th Annual Diabetes Technology Meeting showed that PromarkerD protein biomarkers “vastly outperformed both existing diagnostic tests” such as the albumin creatinine ratio “ACR” urine test, and the estimated glomerular filtration rate “eGFR” blood test in predicting future diabetic kidney disease.
Its results being accepted for presentation at the 18th Annual Diabetes Technology Meeting “shows the power of the Promarker technology platform and what Proteomics International is doing in the field of predictive testing for global diseases,” said Proteomics managing director Dr Richard Lipscombe.
Setting predictive standards
Proteomics has confirmed it has followed all Clinical and Laboratory Standards Institute guidelines while using the industry-standard mass spectrometry platform (LDT) and immunoassay (IVD kit) tests in 100 patients with type 2 diabetes.
PromarkerD immunoassays have also received a string of positive results in the recent past.
In clinical studies presented at the American Diabetes Association Annual Scientific Sessions last year and published in the prestigious journal ‘Diabetes Care’ later in the year, indicated that PromarkerD correctly predicted 86% of otherwise healthy diabetics who went on to develop chronic kidney disease within four years.
The strong predictive capabilities of its technology mean Proteomics could potentially market a range of diabetes-predictive tests and establish a cost-effective industry standard that is used by millions of clinics around the world.
Furthermore, PromarkerD has been rated the “world’s leading diagnostic test for diabetic kidney disease” by the global research company Frost & Sullivan in its report titled “Biomarkers Enabling Diabetes and Obesity Management”.
In terms of protecting its technology and intellectual property, PromarkerD has received patent protection in several major jurisdictions including the US, China, Europe, and Japan, “with others pending” according to the medical technology company.
Proteomics has also confirmed that the PromarkerD kit will be used to target “new commercialisation deals” in Japan and India, opening the door to further commercialisation discussions around the world.
In parallel to advancing its immunoassay kits, the PromarkerD mass spectrometry “Laboratory Developed Test” (LDT) has been licensed in the US, Mexico and Spain.
“Diabetes and diabetes-associated diseases are a major global health problem that put an ever-increasing burden on the health sector,” said Dr Richard Lipscombe.
“PromarkerD could save the US healthcare system up to USD100 billion (A$137 billion) per year in direct costs associated with treating end-stage kidney disease,” he said.
This morning’s news helped shares in Proteomics jump 21% to now trade at $0.34 per share.