BioPorto: Receives FDA 510(k) Clearance for NGAL Test in the US
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
BioPorto is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel. It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets.
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