• Proteomics has completed a manufacturing technology transfer of its PromarkerD test
  • Genetic Technologies build model that could create pathway in the US

Proteomics proves it can produce the PromarkerD tests at scale

Proteomics International (ASX: PIQ) announced that it has successfully completed a manufacturing technology transfer of its PromarkerD tests.

The company has produced a pilot batch of 50,000 PromarkerD test components with specialist immunoassay manufacturer, Biotem.

PromarkerD is a prognostic test that can predict future kidney function decline in patients with type 2 diabetes and no existing DKD (diabetic kidney disease).

In August last year, Proteomics contracted Biotem to manufacture the immunoassay kit version of PromarkerD.

Proteomics CEO Dr Richard Lipscombe said the pilot production run was a significant step in demonstrating the technology transfer required for large-scale global distribution.

“Working with a specialist manufacturer like Biotem allows us to build our production capacity to meet the anticipated demand for PromarkerD in the northern hemisphere and worldwide,” he said.

Both Proteomics and Biotem have ISO 13485 certification — allowing Proteomics to extend its regulatory approvals across additional jurisdictions.

It will also allow prospective partners and licensees to have confidence that PromarkerD can be manufactured in high volumes and to international regulatory standards.

At the moment, the 50,000 tests that have been manufactured for quality control and regulatory testing will form part of inventory for initial sales.

“Proteomics was building a robust manufacturing framework that could be applied to the company’s other diagnostics under development, including tests for endometriosis and asthma,” said Lipscombe.

“This successful technology transfer will help accelerate the worldwide roll-out of PromarkerD, as well as the commercialisation of our pipeline of novel diagnostics.”


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Genetic Technologies sees pathway to the US Payer system

Genomics-based biotech Genetic Technologies (ASX:GTG) has announced the completion of an independently developed and validated customisable Budget Impact Model (BIM).

Developed by ALVA10, the BIM illustrates the clinical pathways patients would experience, in addition to the economic implications of commercialisation and utilisation of a new test or device.

The main finding of the model was that the US Payers system could potentially reduce the annual costs of breast cancer treatment by US$1.4 billion.

US Payers, including commercial insurers, large employers, and benefit groups such as Medicare, are typically reluctant to cover new diagnostic tools, with reimbursement often taking years to receive.

GTG’s customisable BIM enables these payers to accelerate their understanding of the economic impact of implementing GTG’s geneType Breast Cancer Risk Assessment Test prior to commercialisation, providing them with a more certain outcome.

GTG’s CEO Simon Morriss noted: “The completion of this work is a critical step towards obtaining reimbursement for geneType Breast Cancer Risk Assessment Test in the world’s largest healthcare market.”

“It will advance discussions with major US Payers supporting the implementation of our test as a ‘standard of care’.

“It is a transformational step for GTG, obtaining coverage and reimbursement and will accelerate the adoption and commercialisation of our breast cancer risk assessment test, effectively providing a pathway for the reimbursement of GTG’s other risk assessment tests such as colorectal cancer.”


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