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BioPorto announces CE mark of near-patient test for kidney injury and milestones for gRAD platform technology

Wed 30th December, 2020 2:57pm
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December 30, 2020
Announcement no. 22

BioPorto announces CE mark of near-patient test for kidney injury and
milestones for gRAD platform technology
* BioPorto has obtained CE marking in the EU for its NGALds, a novel
gRAD-based test for near-patient measurement of NGAL, and announces commercial
launch 
* Its novel SARS-CoV-2 rapid test, also based on the gRAD-platform, is
undergoing clinical testing at the University of California, Davis 
* These two achievements mark significant product milestones for the
Company’s proprietary gRAD platform
BioPorto Diagnostics A/S (BioPorto) announces the self-declaration (CE mark)
in Europe of the NGALds, BioPorto’s first test based on its proprietary
Generic Rapid Assay Device (gRAD) platform for the development of lateral flow
assays.

The NGALds is designed to deliver a semi-quantitative NGAL result in under 15
minutes, without the need for laboratory instrumentation or complex user
training. This makes it ideal for near-patient settings such as physician
offices and urgent care clinics, where a quick assessment of the risk of
kidney injury can help clinicians to better triage patients. As an outpatient
test, it will complement in-patient hospital use of BioPorto’s automated
assay, The NGAL Test™.

“I am very pleased with the rapid progress of NGALds, and of bringing the
first test developed with our gRAD platform to market. As the first in a
series of gRAD-based tests that we are creating, including tests for
SARS-CoV-2 (COVID-19) and sepsis, it highlights the capabilities of gRAD.  It
also reinforces our focus on kidney disease, emphasizing the versatility of
our NGAL technology and our commitment to improving kidney health through
better diagnostics,” said Peter Mørch Eriksen, CEO of BioPorto.

The commercial launch of the NGALds test will be initiated immediately in
Europe through BioPorto’s distribution partners and the company’s sales
team. At a later stage, BioPorto plans to seek regulatory approval of the test
in other markets.

SARS-CoV-2 point-of-care test has been completed and advanced for clinical
testing
In parallel with the development of NGALds, BioPorto implemented an
accelerated gRAD development process to create a rapid test for the SARS-CoV-2
virus. The goal is to offer a simple test that can quickly and accurately
identify infected patients using a non-invasive sample, delivering a result in
under 15 minutes, at a price significantly less than molecular tests.

After completing successful antibody pairing, device prototyping and
production agreements, on December 23rd, BioPorto provided test kits to the
University of California, Davis (US) to test samples from approximately 150
COVID-19 patients.

Results are expected in early 2021; if positive, BioPorto plans to proceed
with steps to submit an Emergency Use Authorization (EUA) request to the US
Food and Drug Administration (FDA) and a CE mark filing in the EU for the
COVID-19, gRAD-based test.

The content of this announcement does not alter BioPorto’s financial
guidance for 2020 as most recently presented in the Interim Report for the
third quarter of 2020.
For further information, please contact:

Peter Mørch Eriksen, CEO

Telephone +45 4529 0000, e-mail: investor@bioporto.com

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 .


Attachment
*     2020 12 30 Announcement no. 22
(https://ml-eu.globenewswire.com/Resource/Download/9439a0d2-13e2-4132-9109-99b870e8d201)
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