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"BIOPORTO A/S: BIOPORTO RECEIVES COMMUNICATION FROM FDA REGARDING THE NGAL TEST
22:40
October 3, 2018
Announcement no. 17
BioPorto receives communication from FDA regarding The NGAL Test
BioPorto A/S (BioPorto) announces today that the company has received
communication from the U.S. Food and Drug Administration (FDA) regarding
the application for regulatory clearance of The NGAL Test for risk use
with acute kidney injury in the U.S.
The communication states that additional data will be required to support
the AKI rule-out claim in order to continue the application process.
BioPorto will now enter into a dialogue with FDA to further clarify these
issues. Based on the foregoing, Managements expectation as to the timing
of FDAs decision regarding clearance of The NGAL Test is therefore
postponed to mid-2019.
BioPorto will continue its evaluation of the matters addressed in the
communication from the FDA and will announce any new material decision or
news regarding the NGAL approval process.
The content of this announcement does not alter BioPortos financial
guidance for 2018 as most recently expressed in the interim report for the
second quarter of 2018.
For further information, please contact:
Peter Mørch Eriksen, CEO
Ole Larsen, CFO
Telephone +45 4529 0000, e-mail: investor@bioporto.com
About BioPorto
BioPorto is an in-vitro diagnostics company that provides healthcare
professionals in clinical and research settings a range of diagnostic tests
and antibodies. BioPorto has its headquarters in Hellerup, Denmark and is
listed on the NASDAQ Copenhagen stock exchange".
Attachment
* 17 announcement 2018 10 03
https://prlibrary-eu.nasdaq.com/Resource/Download/b4662eec-9953-48c9-a369-b64566be6ef7
© GlobeNewswire
22:40
October 3, 2018
Announcement no. 17
BioPorto receives communication from FDA regarding The NGAL Test
BioPorto A/S (BioPorto) announces today that the company has received
communication from the U.S. Food and Drug Administration (FDA) regarding
the application for regulatory clearance of The NGAL Test for risk use
with acute kidney injury in the U.S.
The communication states that additional data will be required to support
the AKI rule-out claim in order to continue the application process.
BioPorto will now enter into a dialogue with FDA to further clarify these
issues. Based on the foregoing, Managements expectation as to the timing
of FDAs decision regarding clearance of The NGAL Test is therefore
postponed to mid-2019.
BioPorto will continue its evaluation of the matters addressed in the
communication from the FDA and will announce any new material decision or
news regarding the NGAL approval process.
The content of this announcement does not alter BioPortos financial
guidance for 2018 as most recently expressed in the interim report for the
second quarter of 2018.
For further information, please contact:
Peter Mørch Eriksen, CEO
Ole Larsen, CFO
Telephone +45 4529 0000, e-mail: investor@bioporto.com
About BioPorto
BioPorto is an in-vitro diagnostics company that provides healthcare
professionals in clinical and research settings a range of diagnostic tests
and antibodies. BioPorto has its headquarters in Hellerup, Denmark and is
listed on the NASDAQ Copenhagen stock exchange".
Attachment
* 17 announcement 2018 10 03
https://prlibrary-eu.nasdaq.com/Resource/Download/b4662eec-9953-48c9-a369-b64566be6ef7
© GlobeNewswire
