The application lays the groundwork for the test to be added to the Medicare Benefit Schedule...
PromarkerD registration submitted to the TGA
Proteomics International Laboratories Ltd is pleased to announce it has filed a submission to the Australian Therapeutic Goods Administration (TGA) for inclusion of PromarkerD – the world’s first predictive test for diabetic kidney disease – in the Australian Register of Therapeutic Goods (ARTG).
Managing Director Dr Richard Lipscombe said this was an important step for the national and global roll-out of PromarkerD because Australia is one of the major reference countries in addition to the US Food & Drug Administration (FDA), European Union CE Mark, Health Canada and Japan. “Home country approval will also enable product registration to proceed in multiple other countries, for example South-East Asia and the Middle East, where we see substantial market opportunities”, he said.
