• PIQ came out of trading suspension and surged 13pc
  • PIQ says the US has set a national reimbursement price for PromarkerD
  • Kazia awarded a late breaking oral presentation for paxalisib


Proteomics International Laboratories (ASX:PIQ) surged 13% after its shares came out of voluntary trading suspension this morning.

PIQ announced a major milestone in the commercialisation of its predictive test for diabetic kidney disease, PromarkerD, with the US Centers for Medicare & Medicaid Services (CMS) setting a national reimbursement price for the test in the US.

The CMS has listed and assigned a reimbursement payment rate of US$390.75 for PromarkerD in the US.

This rate is set for all patients accessing government-funded healthcare in the US – Medicare covers those over the age of 65, while Medicaid covers eligible low-income Americans.

It will be delivered through Sonic Healthcare USA, and is expected to become final after a 30-day period of public comment, with effective date of 1 January 2024.

CMS is the single largest payer for health care in the US, with Medicare and Medicaid are collectively responsible for 42% of healthcare spending.

Meanwhile, the Australian Therapeutic Goods Administration (TGA) has advised that its decision not to include the PromarkerD test in the Australian Register of Therapeutic Goods (ARTG) was due primarily to change of manufacturer.

The TGA’s decision will temporarily impact the ability of Proteomics to sell its test in Australia, but does not affect its activities in the US, where the test uses the CLIA Laboratory Developed Test (LDT) framework; or Europe, where PromarkerD is CE Mark registered.

In the US, an estimated 32 million people — or 11% of the adult population — live with diabetes. And in Europe, there are 61 million (7%). In contrast, Australia has 1.5 million adults (6.4%) living with diabetes.

The total cost of diabetic kidney disease is US$130 billion per year in the US alone, according to the US Renal Data System.

“The company’s immediate focus is firmly on the major markets of the USA and Europe,” says PIQ CEO, Richard Lipscombe.

“The CMS pricing of US$390 per test in the US is testament to the clear value the PromarkerD test can deliver to the US health system, whilst our existing CE Mark registration underpins our plans to access the European market.”


Kazia to present a ‘Late-Breaking Abstracts’  for paxalisib

Kazia Therapeutics (ASX:KZA) has been awarded a late breaking oral presentation at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting.

The presentation will cover data from an ongoing Phase II study (PNOC022, NCT05009992) of paxalisib, an investigational drug for the treatment of diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs).

In line with conference publication guidelines, Late-Breaking Abstracts, for which no more than six will be selected, will be made public at 7:00am (EST) on the first day of the scientific meeting, Friday, November 17.


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