OREANDA-NEWS. BioPorto A/S (“BioPorto”) has entered into a global distribution agreement with Roche, under which BioPorto will deliver a neutrophil gelatinase-associated lipocalin (NGAL) test for use on Roche’s cobas c 501/c 502 analysers.

The agreement has significant strategic importance to ensure the expanded availability of NGAL tests, as well as enhancing the awareness of NGAL as a diagnostic marker for acute kidney injury. BioPorto expects the agreement to generate revenue starting in 2019.

Under the terms of the agreement, Roche will have worldwide exclusive distribution rights for the NGAL test adapted for use on Roche’s cobas c 501/c 502 systems. 

The NGAL Test™ is CE marked and BioPorto is currently conducting clinical studies to generate data for FDA approval, which is expected later this year. 

Peter Morch Eriksen, CEO of BioPorto, said "I am very happy to enter into a collaboration with Roche, who as a dominant player in the diagnostic space will ensure a broad global distribution of our NGAL test to address a critical need in patient care today.” 

Every year about 13 million people are affected by acute kidney injury worldwide, of which about 4 million die. Nevertheless, there has been no real progress in methods of diagnosing kidney injury over the last half century. Existing methods such as serum creatinine determination, only signal kidney failure 24-72 hours after the injury has taken place. In contrast, NGAL rises to diagnostic levels within a few hours of kidney injury and thus enables the physician to make vital clinical decisions before the damage progresses to potentially fatal renal shutdown. In addition to helping the patient, cost-benefit analyses show that implementing NGAL testing will contribute to reducing hospital costs in the management of kidney injury and its consequences.

BioPorto Diagnostics A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Our pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury. We sell our products in more than 80 countries through diverse sales channels and partners. BioPorto has its headquarters in Copenhagen, Denmark and is listed on the NASDAQ Copenhagen stock exchange.