Onwards and upwards! ASX: 3 March 2020Components ofPromarkerD...

Onwards and upwards!

ASX: 3 March 2020

Components ofPromarkerD

There are three distinct components of PromarkerD, which require approval across each major jurisdiction (European CE Mark, US FDA, Australian TGA), namely:

1. PromarkerD mass spectrometry (MS) version – Test designed for sophisticated laboratories. In the US, CLIA Certified laboratories can run the MS version of the test without FDA approval.

2. PromarkerD immunoassay (IA) kit version – Traditional platform technology, which virtually all competent laboratories globally can run. Proteomics required to get approval in all jurisdictions for the IA Kit version to be used. IA Kit version enables fast throughput and easy adoption globally.
3. PromarkerD Hub - an integral component of the PromarkerD test system and processes data obtained from the PromarkerD mass spectrometry (MS) or immunoassay (IA) technology platforms.

CE Mark – Europe

1. PromarkerD MS version – CE Mark registration granted 12 November 2019.

2. PromarkerD IA kit version – It is expected that Proteomics will apply for CE Mark Approval in Q1 CY2020. Approval should be granted shortly after submission, given the prior approval of the MS version and comprehensive data pack. Approval on 16 April 2020.

3. PromarkerD Hub – CE Mark registration granted on 14 January 2020

CE Mark provides assurance to potential licensing partners and consumers in the EU that the product has been developed and manufactured to meet EU safety, health and environmental protection requirements. The successful registration of the IA kit version of PromarkerD, will provide complete CE Mark approval. This is a major milestone for Proteomics as it:

• facilitates the widespread sale and distribution of both versions of PromarkerD across Europe;

• significantly de-risks PromarkerD in the eyes of tier-1 diagnostic companies that Proteomics are endeavouring to execute a significant, European licensing transaction with; and

• will build a solid case for PromarkerD to receive US FDA approval.

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 lodgethe US FDA application by mid-year 2020.

• PromarkerD Hub - Proteomicsintends to lodge the US FDA application by mid-year 2020.

CE Mark approval and potentially the inclusion of data from the Janssen collaboration is expected to support and expedite the FDA approval process. Based on similar submissions the Company anticipates receiving FDA approval 6 – 9 months post lodgement, assuming there are no requests for additional data. 17 https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA