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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.

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