In an effort to prioritize Emergency Use Authorizations (EUA), the FDA does not recommend that BioPorto pursue an EUA for its NGAL assay for the prediction of renal replacement therapy in COVID-19 patients
20 November 2021 - 3:05AM
In an effort to prioritize Emergency Use Authorizations (EUA), the
FDA does not recommend that BioPorto pursue an EUA for its NGAL
assay for the prediction of renal replacement therapy in COVID-19
patients
November 19,
2021Announcement
no. 23
In an effort to prioritize Emergency
Use Authorizations (EUA), the FDA does not recommend that BioPorto
pursue an EUA for its
NGAL assay for
the prediction of renal replacement
therapy in COVID-19 patients
In July 2021, BioPorto A/S (BioPorto) initiated
a dialogue with the US Food and Drug Administration (FDA) on a
potential Emergency Use Authorization (EUA) of an NGAL assay for
use in predicting the need for renal replacement therapy in
COVID-19 patients. The dialogue was based on results from an ELISA
and dipstick study of NGAL to screen for renal failure in COVID-19
patients conducted by clinical researchers at Columbia University’s
Irving Medical Center, reporting a 97% negative predictive value
for the need of renal replacement therapy.
This week, the FDA provided guidance to all
In-vitro Diagnostics manufacturers that the FDA will focus its
reviews on at-home and point-of-care COVID-19 diagnostic tests,
certain high-volume lab-based molecular COVID-19 tests from home
collected specimens, and requests supported by US government
stakeholders. Consistent with this communication, the FDA has
informed BioPorto that it does not recommend submitting an EUA
application. Based on this feedback, BioPorto has decided not to
pursue an EUA for an NGAL assay with this application for COVID-19
patients.
“With the exciting data from Columbia
University, we saw an interesting opportunity to use the study as a
foundation for an EUA of an NGAL assay in screening patients for
the need of renal replacement therapy in COVID-19 patients. As the
FDA has now decided to prioritize other areas within COVID-19, we
have decided to discontinue this path,” said Dr. Christopher Bird,
Chief Medical Officer at BioPorto.
This announcement does not alter BioPorto’s
financial guidance for 2021 as most recently presented in the
Interim Report for Third Quarter 2021.
For further information, please contact:
Dr. Christopher Bird, Chief Medical Officer,
BioPorto A/S, +1 858 868 1814Tim Eriksen, Investor relations,
BioPorto A/S, +45 61 68 77 79Email: investor@bioporto.com
About BioPortoBioPorto 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 11 19 - Announcement no. 23
Bioporto A/s (LSE:0JJM)
Historical Stock Chart
From Apr 2024 to May 2024
Bioporto A/s (LSE:0JJM)
Historical Stock Chart
From May 2023 to May 2024