The Important First US NGAL-patent

Today BioPorto was granted their first US patent (the ratio patent) . This is truly a milestone… Hip-Hip-Hooray… The Patent is measuring the ratio between NGAL levels in urine and plasma.

Why is this important – you might ask…

A: it is the FIRST US patent – its significance can not be overrated

B: It is an extremely accurate method

C: BioPorto has the ONLY test worldwide than can provide this linearity and specificity – and the ONLY test that can measure in both bodily fluids 

D: It will prove a vital and important support under the next round in the EPO, whrer the original clinical study was under attack

Today – The USPTO  has approved issuing a Patent application number 12/531, 986, related to measuring the ratio between NGAL levels in urine and plasma, and by doing so obtaining highly accurate diagnostic values for the determination of AKI.

The revolutionizing patent protects a method for comparing NGAL levels in urine and plasma, and it increases the diagnostic specificity and sensitivity for AKI . The method is complementary to the cut-off patent (250 ng/ml)  in certain clinical situations, but importantly it can also be used as “stand alone” measurement. It is extremely accurate and this will be a breakthrough in diagnosing other illnesses. BioPorto’s NGAL Test is optimised to take advantage of using use the ratio method, and The NGAL Test ‘s full superior potential in comparison to other Tests because it can measure NGAL levels in both urine and plasma simultaneously and under identical conditions.

USPTO is also currently reviewing the NGAL cutoff patent application, as you all know it defines  the various cutoff of 250 ng /ml for AKI and 1000 ng/ml for dialysis

The cutoff-patent application is still pending before the U.S. Patent Office.  The “normal” NGAL cutoff -measurements shows slightly lower specificity than those obtained using  the ratio method, but the advantage of this “simpler” method versus the Ratio-approach is that you only need one sample, it can be either urine or plasma. The NGAL Test is designed to  identify and determination acute kidney injury on just one sample.

danish text from BioPorto

De amerikanske patentmyndigheder har godkendt at udstede BioPortos patent, ansøgningsnummer 12/531,986, vedrørende anvendelse af ratio mellem NGAL koncentrationer i urin og plasma, for at opnå meget nøjagtige diagnostiske værdier til bestemmelse af akut nyreskade.

Patentet beskytter en metode, der ved sammenligning af NGAL niveauer i urin og plasma øger den diagnostiske specificitet og sensitivitet for akut nyreskade. Metoden er et supplement til cut-off patentet i visse kliniske situationer og kan også virke selvstændigt som et meget nøjagtigt alternativ. Selskabets The NGAL Test™ er optimal til at udnytte ratio-metodens fulde potentiale, idet den tillader målinger i både urin og plasma under identiske forhold.

Udover det netop godkendte NGAL ratio-patent har BioPorto indleveret patentansøgning i USA for NGAL cutoff-metoden, der beskriver det cutoff på 250 ng/mL eller højere, som kan anvendes til diagnostik af akut nyreskade. Denne ansøgning er fortsat under behandling hos de amerikanske patentmyndigheder. NGAL cutoff-metoden giver lidt mindre specificitet end ratio-metoden, men fordelen ved denne metode er, at der alene skal måles på én prøve, enten plasma eller urin. The NGAL Test™ er ligeledes optimal ved anvendelse af denne målemetode til bestemmelse af akut nyreskade.