FDA Approval • PromarkerD MS version – Does not initially...

FDA Approval
• PromarkerD MS version – Does not initially require FDA approval as CLIA certified laboratories may run the test. In total, CLIA covers approximately 260,000 laboratory entities.17 For non-certified laboratories to run the MS version, FDA approval will be necessary (most laboratories with a mass spectrometer are CLIA certified).
• PromarkerD IA kit version – Proteomics intends to lodge the US FDA application by mid-year 2020.
• PromarkerD Hub - Proteomics intends to lodge the US FDA application by mid-year 2020.

The path to commercialization(From Sep 18 article Dr. T. Boreham)
Dr Lipscombe dubs the company “revenue ready”, with some initial licencing deals in test
markets.
The company initially will focus on commercial laboratory clients, especially in the US, with
the test integrated into the labs’ standard panels.
“Having got the tech into a simple-to-use immune assay format, we are in dialogue with a
number of groups about getting that test available,” he says.
“In parallel with that, we would look at FDA approval for the kit version.”