Thanks so much @patyccc, I ran out of lightbulbs last night & time, sorry for the late reply. :)
This company are well funded to market this test, but what it will all boil down to is EVIDENCE based research & predictability of the test. I still can’t quite get my head around the PPV, over 50% in very high risk patients(15%), whereas PromarkerD is 86% PPV in all patients who haven’t yet developed stage 1 CKD. And this is just for rapid progression to ESKD. PromarkerD has a 98% NPV which tops their numbers also.
The Janssen data is going to be really interesting >3000 cohort. I still think this is what they are waiting on (PIQ) & potentially a CDx & that totally makes sense to wait for FDA application, although we have already applied for the CTP code for PromarkerD in the USA. I do think more than ever, this is why we have waited so long for any deal ANNs, it’s not because we can’t, it’s just waiting on trial results & the right deal.
Something else that did cross my mind was the reliance on EMR (Electronic medical records) for this AI based test. For example, Australia has only just come on line in the last couple of years for clinical notes, pathology tests have been for a while, but each state & health service is different as to where they are up to with EMR. You would imagine this would be varied across juristrictions & countries. This test is partially reliant on this.
A lot of panic over COV19. Most ASX stocks red. Diabetes will hospitalise more people with complications & kill more than CoV19. In our LHD, it’s been declared a pandemic. The rise of diabetes is 1-2% PA from research & our demographic data has helped to identify target groups to work with. The spike is massive in the last 5 years & young people on Dialysis.
I hope that data collected in Australia too will prompt the TGA to approve PromarkerD quickly & not rely on EMA & FDA approval first. If anything is going to be done about this, then there must be some forward thinking. They have approved the online for export, but what about here?
GLTAH :)
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