Proteomics International Secures $12M, Launches PromarkerD with New AMA Billing Code

Proteomics International Laboratories has secured $12 million to fast-track its precision diagnostic tests, including the US launch of PromarkerD for diabetic kidney disease, backed by a new AMA billing code. The company also advances its pipeline with new patents and commercial partnerships.

  • Completed $12 million capital raise to support diagnostic test launches
  • PromarkerD launched in the USA with AMA CPT PLA billing code granted
  • Clinical validation published for PromarkerEso and PromarkerEndo tests
  • First patent granted for PromarkerEndo in Japan
  • Secured $6 million funding boost to expand precision diagnostics capabilities
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Capital Raise Fuels Expansion

Proteomics International Laboratories Ltd (ASX, PIQ) has completed a heavily oversubscribed $12 million capital raise, positioning the company to accelerate the commercial rollout of its suite of precision diagnostic tests. This infusion of capital underpins the launch of PromarkerD in the United States and Australia, alongside advancing other promising diagnostics in its pipeline.

PromarkerD Launches in the US with Reimbursement Support

PromarkerD, a blood test designed to predict diabetic kidney disease (DKD) years before symptoms emerge, was officially launched in the US at the American Diabetes Association’s 85th Scientific Sessions. This launch marks a significant milestone, as the test now benefits from a dedicated CPT PLA billing code granted by the American Medical Association, facilitating reimbursement pathways and clinical adoption. Initial rollout focuses on California, with plans to expand nationwide, leveraging insights from the Australian launch earlier this year.

Advancing the Diagnostic Pipeline

Beyond PromarkerD, Proteomics International has published strong clinical validation results for PromarkerEso, a non-invasive blood test for esophageal adenocarcinoma, demonstrating high sensitivity and specificity. Meanwhile, PromarkerEndo, targeting endometriosis diagnosis, has achieved a landmark patent grant in Japan, validating its novelty in a major healthcare market. The company is preparing for commercial launches of these tests, supported by strategic partnerships and a digital direct-to-consumer platform.

Strengthening Infrastructure and Market Reach

Proteomics International secured an additional $6 million funding boost to expand its precision diagnostics capabilities through upgrades at its Western Australia Proteomics Facility. This investment will enhance clinical testing throughput, supporting the growing demand for decentralized diagnostics driven by telehealth trends. The company has also entered commercial agreements with major pathology providers in Australia to facilitate blood collection services, underpinning its go-to-market strategy.

Financial Position and Outlook

For the quarter ending June 30, 2025, Proteomics International reported cash receipts of $201,000 and a net operating cash outflow of $3.2 million, reflecting ongoing investment in commercialisation and R&D. Cash reserves stand at $11 million, bolstered by the recent capital raise and expected R&D tax incentives. The company’s diversified business model balances revenue from analytical services with investment in its diagnostic pipeline, aiming for sustainable growth as it scales.

Bottom Line?

With fresh capital and regulatory support, Proteomics International is poised to deepen its foothold in precision diagnostics, but market adoption and reimbursement outcomes will be key to watch.

Questions in the middle?

  • How quickly will PromarkerD expand beyond California in the US market?
  • What are the timelines and commercial strategies for PromarkerEso and PromarkerEndo launches?
  • How will reimbursement pricing decisions by CMS impact PromarkerD’s US market penetration?