BioPorto focused on flagship NGAL acute kidney-injury test but also looking at coronavirus test

Proprietary NGAL Test provides early risk assessment of acute kidney injury (AKI) Test available for diagnostic use in Europe and Canada but not in the US yet Expects 2020 revenue of US$4.3 million based on NGAL sales for research-use-only  Moving ahead with its Danish partner on co-development of a rapid test to detect coronavirus What BioPorto does: BioPorto A/S (CPH:BIOPOR) is an in-vitro diagnostic company based in Hellerup, Denmark that provides health-care professionals in 80 countries a range of diagnostic tests and antibodies to treat obesity and diabetes, innate immunity, allergies and infectious diseases.  The Copenhagen-listed company, founded in 2000, has been aggressively marketing its proprietary NGAL Test, which 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. BioPorto says its NGAL Test can detect AKI in critically ill patients as quickly as 2 hours. It is the only AKI biomarker that can be measured in both human urine and plasma and can run on standard chemistry analyzers. The NGAL Test helps doctors tailor a care plan more quickly and effectively than standard testing, which reduces the risk of renal failure and/or death. The test measures NGAL levels, a biomarker which increases in response to injury. The company says rival tests can take up to 72 hours to detect injury to the kidney. Aside from the test, BioPorto has an established business selling antibodies globally. The company offers more than 400 monoclonal antibodies, which are types of lab-created proteins that can bind to substances in the body, including cancer cells. The antibodies are made by identical immune cells that are all clones of a unique parent cell. The antibodies are used in research disciplines. Recently, BioPorto also partnered with the University of Southern Denmark (SDU) to co-develop a test for early, rapid detection of SARS-CoV-2, the virus that causes coronavirus ((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. How is it doing: In its second-quarter 2020 result, released on August 17, BioPorto revealed 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. 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. Meanwhile, pilot testing in the US of the test for early, rapid detection of SARS-CoV-2, the virus that causes COVID-19 that is being co-developed with the University of Southern Denmark 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). Inflection points: Obtain FDA approval of the NGAL Test for pediatrics  Collect data to support the submission of adult application for the test  Continue to build awareness for NGAL Test, especially in the US More news on rapid coronavirus test development What the broker says: Following BioPorto’s latest results, London-based research house Edison commented: “BioPorto reported a major increase in Q220 sales for the NGAL research use only (RUO) test, to DKK5.0m, up from DKK3.8m in Q219. “This is the single highest quarter for NGAL RUO sales, and uptake in the US has been especially strong, up 95% y-o-y. Sales for the company’s other products were down (DKK1.7m, from DKK4.0m in Q219) reflecting the company’s shift in focus to NGAL. “Although RUO NGAL sales remain relatively small, they represent the beachhead for the eventual launch of the FDA-cleared NGAL Test, which we expect to have first commercial sales in 2021.” What the boss says: In the second-quarter 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."