I missed this very important part of this announcement as I was on holidays. TGA approval as an IVD!
Proteomics International has secured TGA regulatoryapproval for the PromarkerD software as an in vitro diagnostic (IVD) for export use.The PromarkerD software IVD was included on the Australian Register of Therapeutic Goods (ARTG) on the24 July 2019.
The regulatory approval covers use of the PromarkerD software algorithm across Proteomics International'sdifferent platform technologies, which include both mass spectrometry and immunoassay formats.
Thesuccessful TGA approval for PromarkerD software as an IVD forms part of Proteomics International's ongoing strategy to gain regulatory approvals for the pioneering test in multiple jurisdictions.
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(20min delay)