Hi Eqz,I’m sorry if this worried you, but I think it’s better to...

Hi Eqz,

I’m sorry if this worried you, but I think it’s better to share the information with our fellow SH & after doing a bit more reading, I hope that you won’t be so worried.

This is from a Company ANN on validation of KidneyIntelX:

Similarly, in the expanded validation study population, the positive predictive value (“PPV”) ofKidneyIntelX™for RFKD in the Type 2 diabetes population exceeded 50% in those patients who were in the highest 15% of the risk distribution, and a negative predictive value of greater than 95% for patients unlikely to experience RKFD. This compares to a PPV of approximately 30% for standard of care methods. In addition, when the performance target was analysed for the clinical end-point of kidney failure within five years, in the interim results from the expanded validation study the PPV improved further.

Looking at their numbers, yes it’s better than standard of care we have currently(eGFR, UECs, UACR etc), but the PPV (positive predictive value) only exceeded 50% in the patients were in the highest 15% of the risk distribution of patients at risk for rapid kidney function decline. The NPV was 95%, so that’s decent. Also note they have not included any P values in this announcement. The full ANN link:

https://renalytixai.com/positive-interim-results-for-kidneyintelx/

This is in comparison to PromarkerD that has the ability to predict CKD BEFORE it occurs & the risk of progression (not just rapid decline); with an 86% PPV (ALL patients) and a 98% negative predictive value (NPV) to rule out CKD. So PromarkerD will be a far more useful screening tool, has far greater sensitivity & PPV & also NPV. Then factor in the cost of KidneyIntelX US$950.00.

Looking at this company’s ANNS, so similar to ours, placements, regulatory announcements etc. They are a bit ahead of us in the process in the USA at least, but not by much.

This test is reliant on biomarkers, algorithms from databanks & also the patients own electronic medical records. In comparison, PromarkerD is a simple blood test.

Hopefully the Janssen trial collaboration is on the verge of completion & being announced (we are almost in March, so sometime between now & the end of March 2020 as per ANN).

So for a little bit of initial angst reading this, I’m now over the moon to read that PromarkerD is all over this, having something similar to compare our test to & the fact that KidneyIntelX got FDA approval on just exceeding 50% PPV in the 15% of highest risk patients & a decent NPV is interesting, however better than SOC in an unmet clinical need.

GLTAH