June 29, 2021
Announcement no. 13
Pipeline Update Regarding COVID-19 test
BioPorto A/S (BioPorto) is currently developing a point-of-care test for SARS-CoV-2 on the proprietary gRAD platform designed to quickly and easily identify infected patients using a non-invasive sample.
While indicative data from the process and studies in the US and Denmark supports the gRAD platforms strong capabilities as a technology for rapid testing, BioPorto has prioritized to secure a high sensitivity of more than 80% to further strengthen the clinical and commercial potential of the platform technology compared to other rapid test formats.
“Over the last months we have increased sensitivity in our gRAD-based SARS-CoV-2 samples and studies, especially from the data developed and collected in Aarhus (DK). However, we are not yet at our target of 80%. Therefore, we have decided to prolong the data collection and studies and to focus resources on the Danish study site, as we the coming months continue the development of the COVID-19 test for new mutations of the SARS-CoV-2 virus,” says Jan Kuhlmann Andersen, COO of BioPorto.
Conditional upon continued access to patients with SARS-CoV-2, BioPorto expects the data collection to be completed in Third Quarter 2021. If data continues to support BioPorto’s initial laboratory findings, the company as previously announced intends to undertake CE mark filing in Europe and possibly submit an EUA request to the FDA.
The content of this announcement does not alter BioPorto’s financial guidance for 2021 as most recently presented in the Interim Report for First Quarter 2021.
For further information, please contact:
Jan Kuhlmann Andersen, COO, BioPorto A/S, +45 53 80 00 38
Tim Eriksen, Investor relations, BioPorto A/S, +45 61 68 77 79
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].