Brief: BioPorto Receives Communication From FDA Regarding The NGAL Test

BioPorto A/S

04/10/2018 02:21

Oct 3 (Reuters) - Bioporto A/S  BIOPOR.CO :
    * BIOPORTO RECEIVES COMMUNICATION FROM FDA REGARDING THE
NGAL TEST
    * FDA COMMUNICATION STATES THAT ADDITIONAL DATA WILL BE
REQUIRED
TO SUPPORT AKI RULE-OUT CLAIM IN ORDER TO CONTINUE APPLICATION
PROCESS
    * BIOPORTO WILL NOW ENTER INTO A DIALOGUE WITH FDA TO
FURTHER
CLARIFY THESE ISSUES
    * MANAGEMENT'S EXPECTATION AS TO TIMING OF FDA'S DECISION
REGARDING CLEARANCE OF NGAL TEST IS THEREFORE POSTPONED TO
MID-2019

Source text for Eikon:  ID:nGNE6KJKnw 
Further company coverage:  BIOPOR.CO 

 ((Reuters.Briefs@thomsonreuters.com;))