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Analytikerkommentar

BioPorto: Receives FDA 510(k) Clearance for NGAL Test in the US

Af Henrik EkmanEquity Research Analyst
BioPorto

BioPorto announced yesterday after the market close that the company has received the long-awaited FDA approval to market and sell its NGAL test, which will be marketed under the name ProNephro AKI (NGAL). The test can be used to assess the risk of acute kidney injury much faster than the tests currently used in hospitals. This means that the correct and often life-saving treatment can be started more quickly.

Now, production and distribution through partner Roche must be initiated, which is expected to lead to the start of sales of ProNephro AKI (NGAL) in the second half of 2024. Therefore, the approval does not change the expectations for the full year of 2023.

BioPorto has received approval to use the test on children and young people under the age of 22. As previously announced, the company will begin as soon as possible to seek approval for use of the test on adults, as well as use of the test in other types of clinics and geographic areas, as these markets are significantly larger than the market for use of ProNephro AkI (NGAL) for pediatric use (aged 3 months through 21 years).

Sign-up for event with CEO Tony Pare Monday 11th. December at 1:00 CET here: Bioporto event

Disclaimer: HC Andersen Capital receives payment from BioPorto for a Digital IR/Corporate Visibility subscription and IR Advisory agreement. /Henrik Ekman 2:05 PM (latest edited 3:00 PM), 08-12-2023.

BioPorto er et dansk In-vitro diagnostisk (IVD) selskab med hovedkontor i København, Danmark. Selskabet blev grundlagt i 2000. BioPorto har allerede ét produkt på markedet, NGAL-testen, som er til tidlig diagnosticering af akutte nyreskade (AKI). Den er kommercielt tilgængelig i Europa, Canada, Asien og Israel. NGAL-testen har modtaget banebrydende betegnelser fra FDA for akutte nyreskader til babyer, børn og unge under 18 år for hvilken den i øjeblikket udfører dataanalyser efter afslutningen af indrulning af patienter til dets fase 3-studie, som vil føre til en ansøgning til FDA. Fremtidige planer inkluderer yderligere FDA-indsendelse til voksenindikation såvel som andre markeder.

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