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Message from the Managing Director

It's been a busy quarter for Proteomics International, with the announcement of two key manufacturing milestones for our PromarkerD test for diabetic kidney disease—ISO 13485 certification and the groundwork for a scale-up of production of immunoassay reagents and kits. At the same time, we're progressing our bid for US FDA approval for PromarkerD with the regulatory body.

Our pipeline of diagnostics under development is evolving well, and we now have four biomarker research programs at the ‘clinical validation’ stage—endometriosis, Giardia, oxidative stress and oesophageal cancer.

Also in this newsletter, we have included a list of planned conferences for 2021 – the team has been busy generating new results on the performance of PromarkerD, which we look forward to presenting to global audiences. 

Finally—we're expanding again! Our executive team is set to be bolstered by the appointment of a Chief Commercialisation Officer and Chief Financial Officer to help accelerate our growth in global markets.

Stay well,

Dr Richard Lipscombe
Managing Director

Proteomics International achieves ISO 13485 certification

Proteomics International received ISO 13485 certification, the most widely-used international standard for quality management systems in the manufacture of medical devices.

The standard provides the foundation for regulatory requirements in the European Union, Australia, Japan, Canada and the United States, and is a key milestone underpinning production and future global sales of the PromarkerD test for diabetic kidney disease.

ISO 13485 certification is awarded to companies that can demonstrate an ability to produce safe, effective products that consistently meet the expectations of customers and regulators. The ISO 13845 certification will also apply to Proteomics International's pipeline of other diagnostics currently under development. 

Read more

Promarker™ pipeline advances

Proteomics International is beginning to reap the benefits of the Company’s strategy to expand its diagnostic development pipeline in 2020. Several biomarker research programs have recently progressed to the next stage of the Promarker™ pipeline, including four at the ‘Clinical Validation’ stage. All programs are in areas of unmet need and have the potential to deliver significant value for the Company.

Read more

PromarkerD assay manufacture

Proteomics International has instigated several processes that will facilitate the scale-up in production of the PromarkerD immunoassay reagents and kits. This includes production of specialist synthetic protein standards and stabilised recombinant versions of the antibodies (used to detect the target protein biomarkers). Proteomics International has also commenced discussions with selected Northern Hemisphere diagnostics manufacturers to scale and streamline future production for the European and US markets.

Proteomics International files US FDA 513(g) regulatory submission

Proteomics International has filed a 513(g) submission to the United States Food and Drug Administration (FDA) for the PromarkerD test for diabetic kidney disease. The application will allow Proteomics International to determine the best regulatory path for PromarkerD - either the De Novo Classification or 510(k) route.

The FDA is expected to assess the application and provide feedback within 60 days, and the Company is preparing to file a full application in Q3 CY21.

2021 Conferences

Proteomics International continues to engage with Key Opinion Leaders (KOLs) through conference presentations and the publication of clinical results in leading scientific journals. KOLs and peer review publications are crucial in driving physician, payer and patient-advocate engagement, which in turn will drive adoption of PromarkerD.

The Company will attend several global conferences in 2021, with the latest results on PromarkerD presented in concert with these events:

Executive Management personnel search underway

Proteomics International has engaged international recruitment companies to bolster its Executive/Upper-Management via the appointment of a Chief Commercialisation Officer and Chief Financial Officer. These appointments are nearing completion and will help drive the next phase of the Company's expansion strategies to accelerate its growth in global markets.

Proteomics International - Fast facts

Proteomics International is a medical technology company specialising in predictive diagnostics and advanced analytical services using proteomics - the industrial scale study of the structure and function of proteins.

To improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.

To help create a world where disease is detected early and cured simply.
Dr Richard Lipscombe
Managing Director
  Chuck Morrison
Head of Business Development
  Dr Kerryn Garrett
General Manager
Dr Pearl Tan
PromarkerD Business Manager
  Dr Javed Khan
Analytical Services Business Manager
  Dr Scott Bringans
Research Manager

Proteomics International – India
+ 91 8527 699 192
  Malaysia / Indonesia / Thailand
Apical Scientific Sdn. Bhd.
+ 603 8943 3252
Axil Scientific Pte Ltd
+ 65 6775 7318
Leave a Nest Co. Ltd
+ 81 3 6277 8041
Australian Securities Exchange

Stock Code

  Investor Relations
Dirk van Dissel

+61 408 326 367
Issued Capital – Ordinary shares  
105.2 million
      Market Capitalisation based on share price of $1.31
A$124.1 million

Proteomics International is a wholly owned subsidiary of Proteomics International Laboratories Limited (ASX: PIQ).

Proteomics International Laboratories Limited

  +61 8 9389 1992 (general) (business development)
  QEII Medical Centre
6 Verdun Street, Nedlands
Perth WA 6009 Australia
Forward looking statement
Any forward looking statements in this newsletter have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors many of which are outside Proteomics International Laboratories Limited’s control. Important factors that could cause actual results to differ materially from any assumptions or expectations expressed or implied in this newsletter include known and unknown risks. As actual results may differ materially to any assumptions made in this newsletter, you are urged to view any forward looking statements contained in this newsletter with caution. This newsletter should not be relied on as a recommendation or forecast by Proteomics International Laboratories Limited, and should not be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
Copyright © 2021 Proteomics International, All rights reserved.

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