BioPorto A/S (CPH:BIOPOR) announced Thursday that its proprietary NGAL Test, which provides an early risk assessment of acute kidney injury (AKI), is seeing “growing global interest.”
In fact, rising demand for the test led to a 67% increase in NGAL-related revenue in the first quarter of 2020, the Danish firm said in a statement.
The test helped drive quarterly revenue to DKK 2.1 million (US$303,516), up from DKK 1.3 million (US$187,891) in the year-ago quarter.
READ: BioPorto and University of Southern Denmark fast-track development of test to detect coronavirus
The NGAL test, which is available for research-use-only (RUO) in the US, can detect AKI in critically ill patients as quickly as 2 hours. AKI is a well-known complication that is common after surgeries such as kidney transplants and heart-bypass.
BioPorto, based in Hellerup, Denmark, has been pushing for US Food and Drug Administration clearance (FDA) for its diagnostic use in children. The company is currently conducting studies for such use in adults.
The company on Thursday said that during the first quarter its clinical and regulatory team successfully developed the study protocol, recruited 10 leading US pediatric hospital sites to participate, and held a pre-submission meeting with FDA.
However, the ongoing coronavirus (COVID-19) pandemic has forced BioPorto to put the study on hold.
“Despite having also completed contracting, site qualification visits, and IRB (Internal Review Board) approval for study initiation, the company was unable to begin patient enrollment due to global COVID-19 pandemic, which has paused all non-critical clinical studies across the US,” the company said.
As a result, BioPorto said it now projects that costs related to the clinical trial as well as the submission of the FDA application will be postponed to the second half of 2020.
Developing COVID-19 test
In other COVID-19-related news, the company said it is moving ahead with its Danish partner to co-development a rapid test to detect the deadly virus.
BioPorto and the University of Southern Denmark (SDU) are working on the test that will leverage the company’s patented Generic Rapid Assay Device (gRAD) technology to deliver results in less than 10 minutes. If successful, a test could be available in the second half of the year.
The firm also announced the completion of a fully subscribed rights issue and capital increase of 24,992,053 new shares at a subscription price of DKK 1.60 (US$0.23) per share.
Net proceeds of DKK 38 million (US$5.5 million) from the issue, together with the company’s current cash position, will fund the clinical regulatory programs for The NGAL test and support continued business development activities.
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