Ivokana futher EU approval achieved!, page-12

Hi Silsol,

thanks so much for your excellent summaries & informative posts.

I wanted to bring this to everyone’s attention:

https://www.google.com.au/amp/s/finance.yahoo.com/amphtml/news/renalytixai-announces-partnership-americas-choice-123000853.html

When I first read this, I was very disappointed. However, this was the path PIQ was going to take with Prism Health in the USA in 2018, utilising CLIA approved labs in the USA, that was until the Janssen collaboration.

While Renalytix have their CPT code (US$950 per test) & will be utilising a CLIA approved lab in UTAH for the test, and conducting an IPO to list on the Nasdaq (a Cardiff based co in the UK), they do not yet have CE Mark approval in the EU or FDA approval. They do not have an approved IVD with Online diagnostic Hub approved in EU as we do.

They do have multiple collaborations with Universities & Mt Sinai Hospital in the USA & are getting a lot of attention in Pharma press at the moment, & will be assisting with a COVID-19 trial in the USA for ESRF.

My disappointment was really in regards to thinking we were close to a CPT code as was ANN late last year, however this was quashed during the recent investor call when the question was asked by one of our fellow investors here (thank you mate), the answer was that PIQ had not yet applied for it.

The cost of our test is far cheaper (whether that be US$55 or US$200), you are still looking at 4:1 patient ratio in cost savings & we have already looked at a comparison of the tests in a recent post.

I must say I was a bit taken aback, but after thinking about things, there must be a very good reason for this in regards to not pursuing the CPT code at the time, and I believe it has to do with the Janssen collaboration, now in Ph2.

I look forward to hearing other’s thoughts on this, and I hope that we may get some explanation as to why we appear to be a bit insular in comparison to RenalytixAI with so much going on in the global DKD/CKD space, especially in light of recent publications that DKD diagnosis is being missed & particularly difficult at the moment with COVID-19, a distinct risk for mortality in Diabetic patients.

GLTAH