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BIOPOR - Bioporto A/S News Story

DKK5.21 -0.2  -3.0%

Last Trade - 13/04/21

Small Cap
Market Cap £167.6m
Enterprise Value £156.3m
Revenue £2.71m
Position in Universe 759th / 1830

Pipeline Update from BioPorto

Wed 3rd March, 2021 4:24pm
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March 3, 2021

Announcement no. 3

Pipeline Update from BioPorto
* BioPorto expects to complete its clinical study and submit a De Novo
application to the FDA for pediatric use of The NGAL Test™ this summer.
* BioPorto awaits US test results for the rapid gRAD-based SARS-CoV-2 assay;
if positive, the Company will proceed towards EUA and CE mark in the second
quarter of 2021.
In 2020, BioPorto A/S (BioPorto) began enrolling in a US clinical study for
pediatric use of The NGAL Test for the risk assessment of acute kidney injury
(AKI). The Company also undertook development of a novel SARS-CoV-2 viral test
based on BioPorto’s Generic Rapid Assay Device (gRAD) platform.

US application for The NGAL Test for pediatric AKI expected this summer

BioPorto’s studies of The NGAL Test that don’t require hospital enrollment
are being finalized according to schedule. However, the study of critically
ill (hospitalized) pediatric patients continues slowly due to delays caused by
the second and third waves of the COVID-19 pandemic.

As of the beginning of March 2021, eight US hospitals have successfully been
recruited to participate in the pediatric trial of NGAL, and BioPorto is
continuing to add new sites to boost enrollment. Subject to further changes
brought about by COVID-19, the Company expects to complete its pivotal study
this summer and submit a De Novo 510(k) application to the US Food and Drug
Administration (FDA).

Test results for gRAD-based SARS-CoV-2 test are pending

Based on the gRAD platform, BioPorto has developed a point-of-care test for
SARS-CoV-2 designed to quickly and easily identify infected patients using a
non-invasive sample. In late December 2020, BioPorto provided its first kits
to the University of California, Davis (US) for testing with samples from
COVID-19 patients.

After encountering initial issues in the trial, development teams on both
sides of the Atlantic have worked together to resolve the challenges and
BioPorto is currently awaiting outcome of the new testing.  If results
support BioPorto’s laboratory findings, the Company will progress with plans
to submit an Emergency Use Authorization (EUA) request with the FDA and a CE
mark filing in Europe in the second quarter of 2021. To further support the CE
mark application, BioPorto is also evaluating options for conducting
additional testing at clinical sites in Europe.

For further information, please contact:

Peter Mørch Eriksen, CEO

Ole Larsen, CFO

Telephone + 45 4529 0000, email

About BioPorto

BioPorto is an in vitro diagnostics company that provides tests and antibodies
to clinicians and researchers around the world. We use our antibody and assay
expertise to transform novel research tools into clinically actionable
biomarkers that can make a difference in patients’ lives. BioPorto is
headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen
stock exchange  CPH:BIOPOR .

*     2021 03 03 - Announcement no. 3
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