ProNephro AKI™ (NGAL), early detection test for Acute Kidney Injury, now commercially available to US Labs through BioPorto’s collaboration with Roche Diagnostics.

August 28, 2025
News Release

ProNephro AKI™ (NGAL), early detection test for Acute Kidney Injury, now commercially available to US Labs through BioPorto’s collaboration with Roche Diagnostics.

Collaboration with Roche Diagnostics is first major commercial step to significantly advance adoption of ProNephro AKI across US hospital institutions.

COPENHAGEN, DENMARK and BOSTON, MA, USA, August 28 – BioPorto A/S (BioPorto or Company) (CPH:BIOPOR), today announced ProNephro AKI (NGAL), the Company’s test for acute kidney injury, is now commercially available to US laboratories through BioPorto’s collaboration with Roche Diagnostics. ProNephro AKI (NGAL) has FDA 510(k) marketing clearance on Roche’s cobas® c 501 analyzers, a fully automated clinical chemistry analyzer for in vitro tests used in hospital clinical laboratories.

ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (ages 3 months through 21 years) in the US. ProNephro AKI (NGAL) is designed to help doctors identify patients at risk of developing, or having persistent, moderate-to-severe AKI within 48-72 hours during their first day in the intensive care unit (ICU). NGAL is a direct real-time marker of kidney cell damage that can detect kidney damage days earlier than serum creatinine.¹ Early detection of AKI may enable prompt intervention to save lives. ProNephro AKI (NGAL) provides an additional data point for clinicians to identify AKI earlier and confidently make complex and potentially life-saving care decisions.

Jennifer Zonderman, BioPorto’s SVP of Global Marketing & Commercialization, commented, “We have crossed another significant milestone in our journey building a commercial platform for kidney diagnostics. The Company’s go-to-market strategy leverages strong research and publications around NGAL which have created high customer interest and have been well received by clinicians in the field. The risk stratification claim allows clinicians to identify those with low risk as well as those with high risk of moderate to severe AKI, initiating personalized medicine for the kidney. Looking ahead to the rest of 2025, we are pleased to address the pent-up demand for ProNephro AKI in the shared customer base.”

BioPorto will continue expansion efforts through education and awareness programs targeting US clinicians and researchers at major scientific nephrology and critical care conferences and scientific forums while Roche advances its efforts to connect with laboratory professionals at events such as the recent ADLM congress.

ProNephro AKI (NGAL) product line expansion continues with the next major milestones including:

Expansion of ProNephro AKI (NGAL) to additional standard lab chemistry instrumentation including cobas c 502, Pro and Pure.
First patient enrollment in the study validating the use of ProNephro AKI (NGAL) in adults, on route to obtaining FDA clearance for the ProNephro AKI (NGAL) test for patients 22+ years of age.

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For further information
Jennifer Zonderman, BioPorto, SVP of Global Marketing & Commercialization, +1 617 694 2918, jmz@bioporto.com
Hanne Foss, BioPorto, Head of Investor Relations, +45 4529 0000, investor@bioporto.com

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 patients’ lives and improving their quality of life with actionable kidney biomarkers – tools designed to help clinicians make changes in patient management. The Company leverages its expertise in 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 risk assessment and diagnosis of Acute Kidney Injury (AKI), 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 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 and FDA cleared ProNephro AKI^TM (NGAL) for pediatric use in the US.

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 www.bioporto.com.

Forward-looking statement disclaimer
Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company’s expectations, intentions and projections regarding its future performance including the Company’s Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company’s ability to successfully market both new and existing products. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company’s business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings, including its Annual Report for 2024, particularly under the heading “Risk Factors”.

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