BioPorto A/S (CPH:BIOPOR) released its second-quarter 2020 results on Wednesday, revealing strong revenue growth from sales of its NGAL kidney damage test in a period defined by the coronavirus (COVID-19) pandemic which it is also involved in the fight against.
Sales of the kidney damage test, which helps clinicians identify urinary or plasma levels of the biomarker NGAL, nearly doubled, jumping 85% year-over-year to 7.1 million Danish Kroner (DKK) (US$1.1 million).
BioPorto has begun enrollment of pediatric patients in its US clinical trial of The NGAL Test for the risk assessment of acute kidney injury (AKI) in critically ill children. The company expects to complete the trial and file a De Novo application for US regulatory clearance of the test in the second half of 2020.
READ: BioPorto enrolls first patients in US paediatric study of NGAL; on track for FDA submission in 2020
In the results statement, Peter M. Eriksen, BioPorto's CEO commented: “In very disturbing and difficult times that have been heavily influenced by the COVID-19 pandemic, I am extremely glad that the employees of BioPorto and their families have remained safe and healthy. While this was critical in the first half of 2020, I am also very proud that we also actively engaged in deploying our technology and expertise, particularly leveraging NGAL and the gRAD platform. We are working hard to transform these efforts into new products that could contribute to the fight against COVID-19 and help to minimize impacts to patients and health systems, potentially as soon as later this year."
He added: “While COVID-19 has certainly changed the global agenda, BioPorto continued to diligently and successfully execute our long-term strategy in Q2 2020. In April we raised DKK 37.9 million in new capital with strong support from our shareholders. In June, we announced the enrollment of the first pediatric patient in the US clinical trial of The NGAL Test, following the end of a COVID-induced pause in global clinical studies. And today, we report very satisfying growth and record-high sales of The NGAL Test due to increasing orders from global distributors and customers.”
The company has also initiated self-declaration of a CE Mark in the EU of its novel NGALds, the first assay developed on BioPorto’s proprietary gRAD lateral flow platform. The NGALds is a rapid test that requires no instrumentation, and therefore is ideal for near-patient settings, such as physician offices and clinics, where an immediate result is of significant value, the company said.
Recently, BioPorto and the University of Southern Denmark (SDU) partnered to co-develop a test for early, rapid detection of SARS-CoV-2, the virus that causes COVID-19. The test is designed to use novel SDU antibodies with BioPorto’s patented gRAD technology to create a dipstick point-of-care test that can detect the SARS-CoV-2 virus from a sample in under 10 minutes.
Pilot testing in the US could begin as soon as the third quarter of 2020, the company said, and if successful could lead to commercial availability before the end of the year, following the US Food & Drug Administration's Emergency Use Authorization (EUA) process.
Looking ahead, BioPorto maintained its financial guidance for 2020, projecting full-year revenue of approximately DKK 30 million (US$4.8 million). The company expects an operating loss of approximately DKK 73 million (US$11.7 million).
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