top of page

Proteomics gets green light to continue diagnostic mission

Updated: Apr 17

Proteomics International Laboratories continues to meet the global safety standards required to develop its diagnostic test products. Credit: File

Proteomics International Laboratories (ASX: PIQ) will continue important research and development for its diagnostic test products after meeting key standards set by the International Organisation for Standardisation.

The company this morning confirmed it had received “ISO 13485 recertification – an internationally-recognised standard for safety and quality management systems in the manufacture of medical devices.

Management says the certification ensures patient safety remains the major priority, with its main purpose to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. It represents a stringent commitment to quality and safety standards in the production of diagnostics tests and has been adopted globally.

Proteomics’ recertification is valid for another three years and is expected to benefit future global sales of its “PromarkerD” test for diabetic kidney disease (DKD) and its strong pipeline of innovative diagnostic tests under development.

PromarkerD is a prognostic test that can predict future kidney function decline in patients with Type 2 diabetes, but who have no existing DKD. The company’s patented assessment uses a simple blood test to detect a unique “fingerprint” of the early onset of the disease.

The company says clinical studies published in leading journals show PromarkerD correctly predicted up to 86 per cent of otherwise healthy diabetics, who went on to develop DKD up to four years before clinical symptoms appeared.

Achieving recertification for another three years demonstrates Proteomics International’s commitment to delivering high-quality products, as well as the Company’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Proteomics International Laboratories managing director Dr Richard Lipscombe

Late last year, the company signed a licence agreement to sell PromarkerD in Chile, expanding its reach into the lucrative Central and South American markets. The deal with long-standing partner Omics Global Solutions will see the test made available in the Republic of Chile, which management says is home to 1.7 million adults living with diabetes – the equivalent of one in eight adults.

Globally, there are 537 million adults living with diabetes – a daunting tally that is forecast to reach 783 million by 2045. In the United States alone, an estimated 32 million people – or 11 per cent of the adult population – live with diabetes, costing that country a whopping US$130 billion (AU$198 billion) a year.

In Chile, the number of people with the condition has risen almost 50 per cent in the past decade.

Just last week, Proteomics’ 66 per cent-owned subsidiary OxiDx was awarded a European patent for its finger-prick technology used in monitoring and measuring levels of oxidative stress.

Management says the patent, which will remain valid until 2039, has been granted in 19 European countries and greatly expands the intellectual property protection coverage of the diagnostic test.

Is your ASX-listed company doing something interesting? Contact:


Commenting has been turned off.
bottom of page