While waiting for News on a distribution Agreement for BioPorto’s NGAL Test, our readers and supporters are eagerly crawling the net.

The last couple of days have seen interesting news from – amongst other developing countries – Romania, Canada, Abbottistan,

The canadian article deals with RRT (renal transplant) , and the role of biomarkers in predicting the need for such

The study is interesting, it concludes  – quote:

For a cut-off NGAL value of 278 ng ⁄ ml, the sensitivity was 76% and specificity was  80%; however, it is difficult to translate this to the patient’s bedside because of the diverse patient populations, specimens and assays used in obtaining this estimate. However,this remains the largest pool of patients studied so far on NGAL, with 1948 patients from nine studies included in this analysis for prediction of need to initiate RRT…… While these data require further confirmation, given the relatively low event rate for patients initiated on RRT, these observations imply that NGAL may have important interaction with conventional crite-ria to aid in the clinical decision to initiate RRT
unquote… RRT is – as the avid reader knows – the last resort – the correct cutoffs are :NGAL Cutoff 
Method of diagnosing renal disorder 1st cutoff > 250ng/ml => renal disorder 2nd cutoff > 1000ng/ml => dialysis

however as the laconically state: Although a case could be made that early AKI detection could encourage ‘‘avoidance of harm’’, such as nephrotoxic medications or premature stepdown from the intensive care unit (ICU) the reality in 2011 is that we do not yet have much to offer in terms of therapeutics. I am certain that this we will change rapidly over the coming years – money is being poured into phase II companies (recently by abbott as an example) -because this is virgin territory – and vast sums can be made

The romanian article is focusing on the NGAL , not only in the RA -format – but also in the ELISA-format.

The have some – hmm – interesting – point of views – but when you look at the conclusion – the choice of words is – hmmm – questionable :) – quote:

Lets look at the role of NGAL in determing: –

NGALs has no predictive value for AKI, but the risk to develop AKI is 3 times higher for NGALs baseline and 5 times higher for NGALs at 6 hours and 12 hours, with a cut-off of 150 ng/ml.

Unquote –  avid readers of this blog will of course know – that this is a wrong cutoff – that will result in many false positives. Also  the measurements should be carried out earlier. So – we are to base our conclusions on the wrong cut-off and too late..

Anyway the Romanians conclude:

Earlier diagnosis and intervention should significantly reduce the morbidity and mortality associated with AKI. The NGAL tests are now becoming available in the clinical practice, and will change the diagnosis and management of AKI.
Link the conclusions with the goals of the study but avoid unqualified statements and conclusions not adequately supported by the data. (highlighted by me)

https://docs.google.com/viewer?a=v&q=cache:Asbv_uGA5_0J:ami.info.umfcluj.ro/index.php/AMI/article/download/380/141+ngal+%2Bhospital&hl=da&gl=dk&pid=bl&srcid=ADGEESh9LnPLHGQazSV09L2T8Ycu6qpVQwVE_ZtDtuUEqgOjFZorJXVBT3BkzE0uwv8Yz4GtVkZMiMzBr63Gcs6i5dGtZ8wqsDlX93TsP3wPMg7mr_BHbrGBAog-7_WDDQkNeWDe7Um9&sig=AHIEtbT_FaUGEGHZ2gU7xBmoR99Ir744mA

more articles are published about the relevance of measuring NGAL in connection with Diabetes2. Even if this is not related to BioPorto’s patent – is is related to BioPorto’s NGAL Test – because the test has shown extraordinary linearity  (http://www.sentinel.it/upload_doc/scientific/92-1-cclm%202011%208391.pdf)

the articles Conclude that: The level of urine NGAL in patients of type 2 diabetes is elevated, the level of urine NGAL in patients of type 2 diabetes with microalbuminuria is increased significantly.

http://www.res-medical.com/endocrine-glands/106258

the article goes hand in hand with the medicoinvestor post on diabetes mellitus

here is an easy-to-read introduction to microalbuminuria

http://www.kidney.org/news/newsroom/fs_new/microalbindbkd.cfm

Our secret Agent in Abbottistan, has dug up the 2010 number of RA-machines,  Abbott have more than 9400 Architect machines globally (2010)…  just think of the number of test….:):)

http://www.captodayonline.com/productguides/instruments/chemistry-mid-high-2012/architect-c8000-and-ci8200.html

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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