Proteomics International (ASX: PIQ) has achieved a significant milestone with the granting of ISO 15189 certification for its Australian laboratory operations.
The medical testing certification – which adds to Proteomics’ existing ISO 17025, ISO 13485 and CLIA certifications – will assist the company in commercialisation and clinical use of its suite of precision diagnostic tests, including its new PromarkerEso product.
ISO 15189 is the global standard for medical laboratories, outlining the quality management, and technical requirements needed to ensure accurate and dependable test results.
Laboratory-Developed Tests
Managing director Dr Richard Lipscombe said the internationally recognised accreditation would assist in the marketing of its laboratory developed tests in Australia.
These include PromarkerD, which Proteomics launched last month, and the new PromarkerEso product.
“The clinical certification supports our strategic growth trajectory as we advance the commercialisation of our first-in-class diagnostic tests for diabetic kidney disease, esophageal cancer, and endometriosis,” Dr Lipscombe said.
The National Association of Testing Authorities and the Royal College of Pathologists of Australasia (RCPA) awarded Proteomics the new certification following a comprehensive audit of its Western Australian laboratory facilities, systems, and processes.
PromarkerEso Success
Proteomics demonstrated its expertise in the field of precision diagnostics earlier this month, with new results of “enormous significance” showing its first-in-class PromarkerEso blood test is able to diagnose the early stages of esophageal adenocarcinoma (EAC) with high accuracy.
PromarkerEso is a biomarker-based diagnostic test that published studies previously showed could distinguish EAC from negative and healthy controls.
“PromarkerEso has the potential to revolutionise how doctors manage the risk of esophageal cancer, offering a standard blood test that could reduce reliance on invasive procedures and improve early detection rates,” Dr Lipscombe said.
EAC can be more readily treated with early detection, whereas late-stage EAC has a very poor prognosis.
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