BioPorto A/S (CPH:BIOPOR) (FRA:2P4) has shared an interim report which showed that its first-quarter 2021 revenue grew by 33% driven by “strong sales of antibodies” and its flagship NGAL acute kidney-injury test.
The in-vitro diagnostic company based in Hellerup, Denmark, said that revenue from product sales of its proprietary NGAL Test remained at last year’s “high level” with a “solid performance” in the United States.
BioPorto’s NGAL Test provides an early risk assessment of acute kidney injury (AKI), a well-known complication that is common after surgeries such as kidney transplants and heart bypass.
READ: BioPorto focused on flagship NGAL acute kidney-injury test but also looking at coronavirus test
Based on results in the first quarter, the Danish company forecast overall revenue of approximately DKK 30 (US$4.9 million) for 2021.
In a statement, BioPorto CEO Peter M Eriksen said: “Viewed in the light of a quarter still heavily influenced by the severity of the global third wave of coronavirus (COVID-19), I am satisfied with BioPorto’s performance. We drove revenue up by more than 30% by utilizing all of our assets, despite limited access to key markets for key products.”
“In this context, I believe maintaining revenue from product sales of the NGAL Test at last year’s high level is a solid achievement and I am glad to see our own library of antibodies performing very well.”
Eriksen noted that the company’s clinical efforts and regulatory processes have been “difficult to advance in the continued COVID-19 climate.”
“In the first quarter of 2021, we have pushed hard on both clinical programs for the NGAL Test and the COVID-19 gRAD-based test to ensure we meet our timelines ahead,” he added. “We will continue to do this, for example by bringing new hospital sites into our pivotal study to boost enrollment in the coming months.”
BioPorto said that all internal studies to support the company’s US application for the NGAL Test for pediatric acute kidney injury are being finalized according to schedule. “Enrollment continues in the pivotal study of critically ill pediatric patients,” added the company.
Based on the current status of the COVID-19 pandemic, the BioPorto said it continues to expect to “complete its pivotal study this summer.” Once the study is wrapped up, BioPorto plans to submit a De Novo 510(k) application to the US Food and Drug Administration (FDA).
BioPorto and the University of California, Davis are also working to obtain test results on the company’s gRAD-based point-of-care test for the SARS-CoV-2 virus which causes COVID-19. “Having experienced initial challenges early in 2021, the testing is progressing and will be finalized in the second quarter of 2021,” said the company.
“If the results support BioPorto’s initial lab findings, the company intends to submit an Emergency Use Authorization (EUA) request to the FDA and a CE mark filing in Europe,” BioPorto said.
In connection with the release of the interim report for 1Q 2021, BioPorto said it will host an online investor presentation on May 12 at 12:00 CET in Danish and at 16:00 CET in English.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
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