- Proteomics International has signed an exclusive license agreement with Sonic Healthcare USA for the use and commercialization of the PromarkerD predictive test for diabetic kidney disease in the United States
- Estimated 32 million adults or 11 percent of the American population live with diabetes - testing these patients with PromarkerD could help identify their risk of developing diabetic kidney disease
Austin, TX – May 10, 2023
Proteomics International Laboratories Ltd (Proteomics International; the Company; ASX: PIQ) is pleased to announce it has signed an exclusive license agreement with Sonic Healthcare USA, a Division of Sonic Healthcare Ltd (OTCMKTS: SKHHY) for the use and commercialization of the Company's PromarkerD test for diabetic kidney disease in the United States. Under the agreement, Sonic Healthcare USA will be offering PromarkerD to physicians and healthcare systems through its client engagement teams across the US.
PromarkerD is a newly developed blood test that can predict a decline in kidney function in type 2 diabetes. Diabetic kidney disease (DKD) is a major complication arising from diabetes, and PromarkerD is a cost-effective, easy-to-use blood test capable of predicting the onset of the disease in patients with diabetes and no existing DKD.
Sonic Healthcare USA’s Chief Medical Officer Dr. Mohamed Salama said he is looking forward to a fruitful partnership with Proteomics International. “Our goal of this partnership is to offer PromarkerD as a predictive test that will enable clinicians to identify which patients with type 2 diabetes are at risk of developing kidney disease. The PromarkerD test is an important prognostic tool that will substantially advance diagnostic offerings for the diabetic population.”
Proteomics International Managing Director Dr. Richard Lipscombe said he is delighted to enter the license agreement with Sonic Healthcare USA, “Both parties have been working diligently for many months towards the roll-out of PromarkerD in the USA.”
“In signing with Sonic Healthcare USA we believe we have an ideal partner to bring our PromarkerD technology to the world’s premier healthcare market, potentially benefiting millions of patients with diabetes. The US is one of our key addressable markets and we expect this partnership to significantly increase the reach and adoption of PromarkerD through Sonic Healthcare USA’s physician and patient focused channels.”
The license with Sonic Healthcare USA is for five years, extendable by mutual agreement, and exclusive to the United States (excluding Puerto Rico). The license agreement also includes commercially agreed royalties based on sales of the test (at a price which is subject to Proteomics’ reasonable verification and determination), timelines for milestone events to be achieved in relation to the commercialization process (which include, without limitation, mutually agreed arrangements for PLA Code submission and validation, information technology sharing and security, operations and procurement and commercial efficacy validation based on relevant market analysis), and provides terms for payment for PromarkerD test reagents. Under the agreement, SHUSA will be primarily responsible for the marketing and promotion of the test. The agreement is also subject to standard terms and conditions (including confidentiality and the parties continuing to comply with their obligations) and warranties typical for a document of its type. As for any novel test, market penetration cannot be reliably predicted, hence for the new market it is not possible to reliably quantify the potential financial impact on Proteomics International in any given timeframe.
In the USA an estimated 32 million people, or 11 per cent of the population, live with type 2 diabetes1. According to the US Renal Data System, the total cost of diabetic kidney disease is USD 130 billion per year in the USA alone2.
The early diagnosis of DKD using PromarkerD testing in diabetes can help inform doctors' treatment decisions to improve clinical outcomes for patients [ASX: 2 August 2022], and could drive improved therapeutic interventions [ASX: 3 May 2023]. Reducing or delaying the progression of DKD and consequently the incidence of dialysis and kidney transplant would result in significant cost savings for health care systems [ASX: 2 July 2021].
Authorized by the Board of Proteomics International Laboratories Ltd (ASX: PIQ).
About PromarkerD (www.PromarkerD.com)
Diabetic kidney disease (DKD) is a serious complication arising from diabetes which if unchecked can lead to dialysis or kidney transplant. PromarkerD is a prognostic test that can predict future kidney function decline in patients with type 2 diabetes and no existing DKD. The patented PromarkerD test system uses a simple blood test to detect a unique ‘fingerprint’ of the early onset of the disease by measuring three serum protein biomarkers, combined with three routinely available conventional clinical variables (age, HDL-cholesterol and estimated glomerular filtration rate (eGFR)). A cloud-based algorithm integrates the results into a patient risk report. In clinical studies published in leading journals PromarkerD correctly predicted up to 86% of otherwise healthy diabetics who went on to develop diabetic kidney disease within four years.
Further information is available through the PromarkerD web portal.
To visit the PromarkerD virtual booth please see: www.PromarkerD.com/product
About Sonic Healthcare USA
Sonic Healthcare USA is a leading provider of state-of-the-art laboratory and pathology services throughout the USA with eight operating divisions and over eight thousand US based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community based testing services to provide outstanding quality and service to doctors and the patients that they serve. For more information, visit the Sonic Healthcare USA website at www.sonichealthcareusa.com.
About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com)
Proteomics International (Perth, Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company at the forefront of predictive diagnostics and bio-analytical services. The Company specializes in the area of proteomics – the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.
1 International Diabetes Federation Diabetes Atlas 10th edition, 2021
2 US Renal Data System 2020
Sonic Healthcare USA