July 18, 2018
Announcement no. 13
BioPorto A/S (“BioPorto”) announces today that the company has submitted an application to the US Food and Drug Administration, (“FDA”), for regulatory clearance of The NGAL Test™ for risk use with acute kidney injury in the U.S.
BioPorto filed a pre-submission in late 2016 followed by protocol development in early 2017. Patient recruitment was initiated in the second quarter of 2017, and since then more than 500 patient cases have been collected at 17 hospital sites in the US, including Yale, Cleveland Clinic, Houston Methodist Hospital and Massachusetts General Hospital. The application together with the clinical and statistical data from this study has now been filed with the FDA.
“I am very pleased with the process and result of the last years hard work in bringing BioPorto to the point, where we are able to submit our registration application for The NGAL Test™ in the US. I believe that the application we have submitted supports our case of using NGAL in risk support to rule out acute kidney injury within 48 hours in ICU populations, and hence to help secure a faster prioritization of patients potentially suffering from acute kidney injury, which globally affects millions of patients every year,” says Peter Mørch Eriksen, CEO of BioPorto.
Assuming a standard review process from the FDA, a decision regarding the application could be expected in the second half of 2018. If The NGAL Test™ is cleared by the FDA in this timeframe, BioPorto will be in position to commence commercializing The NGAL Test™ by late 2018 or early 2019 in the US, which is the largest geographical market for the test.
The submission of the FDA application does not alter BioPorto’s financial guidance for 2018 as most recently expressed in the interim report for the first quarter of 2018.
For further information, please contact:
Peter Mørch Eriksen, CEO
Gry Husby Larsen, General Counsel
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 Copenhagen, Denmark and is listed on the NASDAQ Copenhagen stock exchange.
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