BioPorto A/S (CPH: BIOPOR), an in-vitro diagnostics company, announced on Friday that it has entered into a global distribution agreement with Roche (VTX:ROG), under which BioPorto will deliver a neutrophil gelatinase-associated lipocalin (NGAL) test for use on Roche's cobas c 501/c 502 analysers.
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 company said this 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 revenues starting in 2019.
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.
BioPorto Diagnostics provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Its pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury.
Innovent treats first cancer patient in Phase I clinical trial of Anti-OX40 Antibody
Mayne Pharma unveils Lexette (halobetasol propionate) foam 0.05% in the US plaque psoriasis market
US FDA posts warning letters to companies illegally selling more than 58 products
Parexel Appoints Former FDA Senior Executives to Global Regulatory Consulting Services
US Patent Issued for AXA Candidate AXA1125
Omeros Names Bumol to Board of Directors
Calliditas Therapeutics announces grant of ODD by US FDA for primary biliary cholangitis
Harmony Biosciences submits Pitolisant NDA with US FDA under priority review
Calliditas Therapeutics wins US FDA orphan drug designation for primary biliary cholangitis