This is definitely what is happening in the world of diagnostics...

This is definitely what is happening in the world of diagnostics in many diseases including genetic testing which often holds the key to difficult to diagnose cases & rare diseases, risk for certain cancers etc.

https://www.sciencedirect.com/science/article/abs/pii/S1056872719304702

Here is a link to the abstract for the most recent PromarkerD study. I am glad they put a glossary in the ANN to explain key terms for the study as Positive Predictive value didn’t look great in the numbers at 30%, but a low number of patients progressed in decline in eGFR. The negative predictive value (NPV) at 98% & Sensitivity at 86% are really very good numbers.

Translating this to clinical use, this will mean a lot for patients tested, both in treatment & follow-up if they are at risk for CKD/DKD & this is where the NPV will be really important.

As a companion diagnostic & for clinical trials, the test will already be valuable as a predictive test. When we are seeing drugs being granted indication for treating CKD/DKD, I also believe this is when things will really take off for PromarkerD, with assistance for clinical decision making for Drs on treatment options for diabetes.

I have always thought the likes of LabCorp (who own Covance, a big global company in clinical trials) may be very interested in PromarkerD for clinical trials, even for other drug indications to predict kidney health on screening patients for clinical trials.

LabCorp is also one of the biggest diagnostic pathology labs in the USA & adding new tests quite regularly to their list of what is available on the diagnostic menu. I guess this is where it is important for patients on what will be covered by Health insurance in the USA & PIQ are addressing this. I’m so glad we have a decent system with Medicare in Australia, the USA is very different in healthcare access & what is covered.

The retrospective study on kidney disease from insurance company records posted some time ago, all these things add weight to evidence of using predictive testing, including peer reviewed publications & let’s face it, it all comes down to Healthcare $$$ in the end, & even Donald Trump has somewhat addressed the healthcare crisis of diabetes & DKD/CKD that has a massive drain on their healthcare system in the USA & globally.

We knew it was coming, it was just a matter of when, and it appears at the moment it’s mostly focused on dialysis access at home & kidney transplantation. Primary prevention will be the key. Timely testing, treatment early before symptoms even start (end stage & symptomatic, as a silent disease)

I believe we are waiting on FDA decision too @Eqz on CKD/DKD indication for Invokana (Janssen). If this is granted, others may follow in the SLGT2 Inhibitor class of drugs to treat kidney disease & CV (cardiovascular disease).

We may be wrong in our thoughts, however when there are drugs available to treat & prevent disease, there will be more indication to use predictive testing in clinical decision making for Drs.

The decision is by FDA is due soon, & application to EMA in Europe has been submitted.

I agree about the MC of PIQ, to me it’s insane. Biotechs take a lot of patience & nothing will happen without Peer Reviewed & published data, as Richard has pointed out & this ANN is an important milestone for PIQ.

We haven’t had comment on it here on HC. I was excited to read the ANN, but take the time to read the abstract first before commenting, and only really had the time this morning. Great news!!

Best wishes All