I don't have a background in medical testing, but it's a bit equivocal.
Sensitivity is the percentage that a positive result is correct and Specificity is the percentage that a negative result is negative.
https://www.healthnewsreview.org/to...ty-specificity-and-positive-predictive-value/
The good news is that the Promarker D is excellent at ruling OUT patients who don't go onto progress CKD in 4 years. It has good specificity in both the "optimum" group and the specificity improves substantially at the moderate to high-risk category.
The point of contention is this news is that the Promarker D has only a modest sensitivity at predicting patients who progress to developing CKD in 4 years. And at the more high-risk levels of Diabetes, it's a very poor test at predicting progression with 59% and 35% in moderate and high-risk groups.
Even Proteomics in the poster has indicated that they can't seem to substantiate why there is a difference between the original Fremantle Diabetes Study with this new analysis on the Credence database.
Big picture, how do these results change practice? I don't completely know.
I think Proteomics needs to clarify the following pieces of information to make sense of it:
1. What is the current level of sensitivity and specificity attached to different levels of Urine Albumin/Creatinine ratio or the 24 hour urine collection in helping predict progression to CKD in the next 4 years. This is the current standard of care but only for having Nephrotic Syndrome rather than predicting the progression in 4 years time.
2. Could Janssen still use Promarker D with a high specificity as a way to justify a model of care to start treating patients with Canagliflozin earlier in their disease trajectory. For example, if a patient's Promarker D is not negative, it's an indication to the clinician to treat them with Canagliflozin until such a point that their Promarker D becomes negative?
Extremely interesting results and I look forward to hearing more thoughts regarding people's analysis on these results. Good luck to all holders.
(20min delay)