Agm question...16 Nov 2020 16:00
Had a reply from Adam,
He always takes the time to engage with shareholders. I am delightedly to be invested here.
I have removed some of the email but just for context have posted the question and response...
Question...
Given the extensive ‘clinical trial’ for EarlyCDT lung do we have to undertake similar trial at scale for liver, prostrate and breast cancer or do we have ‘sufficient data’ for diagnostics.
I refer to slide 12 in the deck and I do not understand the gap in data between lung and say the breast cancer databank given the extensive diagnostics on lung cancer but not the others. Is there a need for more trials/data gathering?
Response...
Typically, diagnostics for early cancer detection (including screening) are developed through a pre-launch phase, and a post-launch phase.
Pre-launch, all diagnostics are Discovered, Developed and Validated (Technical and Clinical) prior to launch with a CE mark, or through a CLIA lab as an LDT. In our case, we can complete this work from a blank sheet of paper to a marketed assay in 6 months.
Post-launch, there is often need for further evidence generation to support registration (in regions not accepting a CE mark or CLIA LDT), adoption and reimbursement decisions; which you can legally sell your test after pre-launch development, their might not be a market for it unless you generate further evidence. Typically, this evidence starts with a retrospective analysis of protectively collected samples. This is then followed by a prospective, an randomised assessment of the test. Finally, a cancer control evaluation might be performed. The purpose of this evidence generation is to demonstrate performance (or clinical utility), hair (or lack thereof) to tested patients, and cost effectiveness.
Today, Oncimmune’s EarlCDT Lung assay has the highest level of evidence of a blood biomarker for early cancer detection; the ECLS study, a prospective, an randomised assessment of the test, took 7 years and £10m of investment to output 2 years of follow up data on 12210 participants; a huge undertaking.
Oncimmune’s strategy is to partner tests as early in the development cycle as possible with those diagnostic companies able to invest in sales, marketing, market access and in market evidence generation; we are currently exploring these options with Ovarian Brest, Prostate and other assays.
.........
Hope that helps folk. He also stressed how difficult it was to strike these deals. Pretty much a reiteration of the vox interview. So I guess once you are in with big Pharma companies and doing deals that in itself is an additional potential entry barrier to others.
Atb
Trek
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