Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) has terminated its exclusive licence agreement with Sonic Healthcare USA for the use and commercialisation of the PromarkerD predictive test for diabetic kidney disease in the United States of America. The termination took effect at 5pm AWST on 10 September 2024.
Proteomics International is now free to license PromarkerD to other parties in the USA, targeting a US launch of PromarkerD in FY25 using two Go-to-Market strategies, namely licensing to alternative pathology laboratories and service providers and direct to consumer/patient (DTC/DTP). The PromarkerD assay has been established in the USA in a third party CLIA certified reference laboratory, and the Company is in discussions with appropriate service providers/partners to enable commercial sales.
Proteomics International's termination of the exclusive licence agreement with Sonic Healthcare USA opens up new opportunities for the company to expand the commercialisation of PromarkerD in the USA. With the potential to address a critical health issue for over 32 million people living with diabetes in the USA, the company aims to make a significant health impact. The PromarkerD test has been demonstrated in multiple peer-reviewed clinical studies to predict renal decline in type 2 diabetes, with recent results extended to type 1 diabetes. The company's strategic move to target a US launch of PromarkerD in FY25 and explore alternative pathways for commercialisation demonstrates its commitment to advancing predictive diagnostics for diabetic kidney disease.