They have approvals in some US states to use the test via CLIA approved labs as they do not have FDA approval so it appears this will be ongoing validation studies. Here is their company announcement for the study presented at the ADA Scientific Sessions:
It’s important to remember that this test is dependent on AI as well as tumour necrosis factor biomarkers. It is to detect rapid functional kidney decline & achieved a PPV (Positive Predictive Value) of 62% in the highest risk group (16%) in their cohort of 1146 patients with EXISTING DKD/CKD Stages 1-3. This is in comparison to existing testing & predictive algorithms that have been shown to be disparate racially:
And also the current standard of care that is predictive of end stage renal failure which is 41% PPV, so any improvement on that is a big plus.
I think it is really important to look at the cohorts (existing CKD in Renalytix trial, Stages 1-3 CKD/DKD) vs normal eGFR (no diagnosed CKD/DKD) in the PIQ/Janssen Trial ~ 3000 patients in a multi-centre international clinical trial (CANVAS) for patients with Cardiovascular disease (CVD) & diabetes.
So for comparison here, we are looking at a trial cohort who all had normal kidney function (eGFR at commencement >60ml/min/1.73m2) & in the highest risk group, the PPV was 73.9% in the Canafliglozin + Placebo group in our study vs 62% in the Renalytix study for patients already diagnosed with Stage 1-3 CKD/DKD & to detect a rapid decline in kidney function. So not only did the PIQ study outshine this in the high risk group on a PPV for a clinical trial roughly 3 times the size, it also detected CKD/DKD in patients who had normal renal function at the commencement of the trial.
The Renaltytix trial identified a 7 fold increase in the highest risk for end stage renal failure in the group for CKD/DKD already diagnosed with earlier stage CKD/DKD, whereas PromarkerD identified a 13 fold risk factor for the highest risk group & validated by a big Pharma collaboration with Janssen (J&J) for patients commencing on the trial with a normal eGFR.
Looking at low risk patients who may develop CKD/DKD, you can’t make a comparison, as the methodology is different, including the testing focus, predictive of CKD/DKD vs predictive of rapid kidney function decline (RKFD), & the cohorts recruited. A healthy cohort in kidney function in PIQ/Janssen trial vs earlier CKD/DKD (Stage 1-3) in the Renalytix trial. Both tests have their merits.
I think the fact that we have EU CE approval already, we can in fact do exactly the same as Renalytix in the USA with CLIA approved labs & our online hub for PromarkerD I find a bit frustrating because we are smaller than Renalytix with a MC of 330 million (which is probably GB pounds, not USD listed on the LSE).
The proof is in the pudding in test results. Surely this will be recognised soon with both companies presenting at the ADA sessions?
PIQ Price at posting:
42.5¢ Sentiment: Buy Disclosure: Held
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