On october 12th 2012 Alere was granted a USpatent on Methods and compositions for monitoring and risk prediction in cardiorenal syndrome
as the abstract says :
The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects. In particular, the invention relates to methods and compositions selected to monitor cardiorenal syndrome using assays that detect NGAL, preferably together with assays that detect natriuretic peptides such as BNP. Such methods and compositions can provide early indications of a deterioration in cardiorenal syndrome status, including prognosis regarding mortality and worsening renal function.
I have not had the time (yet) to digest the whole enchilada – but here is the full text.. only thing I did not see while skimming/browsing quickly through the paper – was, that seems to be no mentioning of a specific cut-off – but I might been mistaken – please investigate for yourself here.
Brilliant… I stand corrected.
The above commentator is wrong. Cardiorenal syndrome is heart failure with AKI and is one of the major conditions associated with AKI. It strikes me as a very useful combination – NGAL ( a great indicator of AKI) and BNP ( a well established marker for all stages of CHF). The prognosis of patients with both conditions is significantly different from those with either condition alone – and instead of niche – not sure about an across Europe number but in UK heart failure affects approx 750 thousand patients a year in the UK with probably 1/4 of these having renal involvement. I see many patients in my practice that would benefit from a test such as this
The patent mentions no cut-off… But it does mention a "baseline value", which should be established on basis of test taken from the individual subject at an earlier time, OR a baseline establish from tests taken from patients suffering from heart failure.
The patents intended use is patients suffering from Cardiorenale Syndrome, which in short is where a patient will suffer kidney injury after a heart attack, or suffer a heart attack after a kidney injury…. and therefore you can predict the one thing if the other has occured.
But I see this patent only as a nieche patent, on an area of no real relevance. And one that can be easily contended in patent feuds. But thats only my oppinion.