BioPorto confirms market acceptance of NGAL products with US standing order.

July 1, 2024 

News Release 

BioPorto confirms market acceptance of NGAL products with US standing order. 

COPENHAGEN, Denmark and BOSTON, MA, USA, July 1, 2024, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), announced today that it has received its first standing order for its NGAL (“neutrophil gelatinase-associated lipocalin”) assays for clinical chemistry platforms. The order is from a US hospital for the research use only (RUO) status test and represents a value of more than USD 200,000 per year. Under the standing order, the hospital will receive a pre-agreed number of test kits distributed evenly across a year.  

“We are excited about this standing order. It is both a clear signal that our customers see the tests’ strong value proposition in terms of ongoing risk assessment for early detection of Acute Kidney Injury (AKI) and an important element in our business model for servicing our customers in the best and most efficient way possible to ensure that the test is available at all times,” said Jennifer Zonderman, Senior Vice President, BioPorto. For a partner or hospital to commit to ongoing use of the test, they have made the decision that patient care is positively affected clinically and that economic measures, such as hospital length of stay or staff efficiency, are evident.  

BioPorto and its partners are in the process of preparing the launch of the test for US commercial clinical use for patients under the age of 22 years under the ProNephro AKI™ label following the marketing clearance of the test received by the Federal Drug Administration (FDA) in late 2023. BioPorto’s ProNephro AKI test is designed to help doctors identify patients at risk for developing or having moderate to severe AKI within 48-72 hours in the intensive care setting. Unlike conventional methods such as measuring serum creatinine levels, the ProNephro AKI NGAL test measures a direct marker of kidney damage and thus can potentially assess the risk of AKI days earlier. 

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For further information 

Jennifer Zonderman, BioPorto, +1 844 424 6767, [email protected]  

Tim Eriksen, +45 4529 0000, [email protected] 

Ashley Robertson, LifeSci Advisors, +1 –617 –430 7577, [email protected] 

 

About Acute Kidney Injury 

Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it difficult for kidneys to maintain the proper balance of bodily fluids. AKI can also affect other organs such as the brain, heart, and lungs and is common in patients who are in hospital intensive care units. For more information about AKI please visit: https://bioporto.com/aki/. 

 

About BioPorto 

BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem. 

The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide. 

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit http://www.bioporto.com.