In another article the expansion of NGAL Test is not seen as a rapid event, as more Multi-Center trials are requested.

Just as we couldn’t get our hands down, the Internet strikes back.. If not fully – then at least partially.

Doctors Stefan Herget-Rosenthal,, Jochen Metzger, Amaya Albalat, Vasiliki Bitsika and Harald Mischak

from Department of Medicine and Nephrology, Rotes Kreuz Krankenhaus, Bremen, Mosaiques Diagnostics GmbH, Hannover, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, Biomedical Research Foundation Academy of Athens,

has published an article with the interesting title:

Proteomic Biomarkers for the Early Detection of Acute Kidney Injury

The article deals with some of the issues at hand – primarily the need for a LARGE multi-center test to end debate on which Biomarker should be the Special One (Jose Mourinho ?) Their conclusion is- quote:

“Irrespective of the approach, large, prospective, multicentre clinical trials on unselected patient populations are required to validate the different proposed biomarkers or classifiers. In analogy to a recent editorial by Vlahou [84], such a large study would best be performed in a way that allows testing all the biomarkers currently proposed. Unfortunately, neither industry, nor government agencies currently see the need for such a large trial.”

unquote

Regarding our Precious NGAL protein their findings are quote:

“As a consequence, prospective multicenter studies are urgently required to determine the performance of plasma and urinary NGAL in unselected ICU patient populations including patients with preexisting CKD . Since the reported cut-off values for NGAL differ across a wide range it seems reasonable to speculate, that each clinical setting may require different cut-off values .”

unquote…

So cutoff values are a key ingredient – this is no surprise to us hardcore cutoff afficionados, everybody (including Abbott/Alere) actually KNOWS that 250 ng/ml is the correct cutoff – but for obvious financial reasons A&A maintain that theirs should be the common denominator.

Nontehless – essentially they are still in favour of NGAL as the non-plus-ultra Biomarker … quote: Taken together, NGAL is the most promising novel renal biomarker in urine and also in plasma. unquote

the other Biomarkes mentioned in the article are the usual suspects with the usual pro and cons…

Oh – by the way – one such multicenter trial is being carried out (in France ??) even as we speak… lets hope for a swift conclusion..

 

 

About Stengaard

BioPorto investor from way back when... I've invested in BioPorto ever since they made their debut on the danish stock exchange, it been a looooong journey with many obstacles. But well worth it all if Bioporto maintains their patent after the proceedings in 2014, and enters into agreements with Global Distributors in 2012 and 2013 If not, then it'll take another xx.years :)

 

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