Proteomics International scores gold standard lab approval in US

Proteomics International Laboratories (ASX: PIQ), a pioneer in precision diagnostics, has achieved a major milestone in its US commercialisation strategy, with the accreditation of its Californian Reference Laboratory by the College of American Pathologists (CAP).

The milestone now places Proteomics alongside more than 8,000 CAP-accredited facilities worldwide, an elite cohort recognised for laboratory excellence.

The accreditation follows a rigorous on-site inspection and is widely regarded as the gold standard for clinical laboratory quality in the United States. It sets more demanding standards than the existing Clinical Laboratory Improvement Amendments (CLIA) certification currently held by the Company’s California-based facility.

Established earlier this year in Irvine, California, the laboratory has also completed the installation and commissioning of a new state-of-the-art mass spectrometry platform.

The advanced instrumentation has expanded the lab’s capabilities beyond its existing immuno-assay systems. Those systems are currently used to deliver the company’s PromarkerD predictive test for diabetic kidney disease to patients in California.

The new platform will also be pivotal to the rollout of Proteomics International’s broader suite of precision diagnostic blood tests in the US market.

Protocols for the company’s flagship PromarkerEso diagnostic test, following last week’s announcement that the screening tool had secured a US patent, are now being implemented in the laboratory, paving the way for its commercial launch in 2026.

PromarkerEso is designed to detect esophageal adenocarcinoma, a prevalent and severe form of throat cancer, which commonly occurs between the mouth and the stomach.

The company’s PromarkerEndo - to detect endometriosis - and other tests in the pipeline will also benefit from the enhanced capabilities of the new spectrometry platform.

“Our Company continues to raise its international profile with these achievements. Attaining CLIA/CAP certification is another important milestone in the commercialisation of the Promarker suite of diagnostics. CAP is a universally recognised clinical accreditation that puts Proteomics International firmly on the map as a leading provider of quality precision diagnostics.” Proteomics International Laboratories managing director Dr Richard Lipscombe

CAP accreditation involves a comprehensive review of laboratory records, quality control procedures, staff qualifications, equipment, facilities, safety programs and overall management.

The process ensures adherence to the highest standards of care, mitigates risk and supports improved patient outcomes.

The company says these developments will significantly strengthen Proteomics International’s position to deliver innovative predictive and prognostic diagnostics in the world’s largest healthcare market.

With CAP accreditation secured alongside its latest spectrometry capabilities, Proteomics International is strongly positioned to accelerate US commercialisation of its Promarker precision diagnostics pipeline.

The upcoming 2026 launch of PromarkerEso represents another milestone along the exhaustive path towards transforming early detection and patient outcomes in esophageal cancer and beyond.

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