July 11, 2024

News Release

Results from Clinical Studies Highlight the Efficacy of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Predicting Acute Kidney Injury

COPENHAGEN, Denmark and BOSTON, MA, USA, July 11, 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), received marketing clearance by the US Food and Drug Administration (FDA) for ProNephro AKI™ (NGAL) for risk assessment of moderate-to-severe acute kidney injury (AKI) for pediatric patients (age 3 months through 21 years) in late-2023.

The results from the EARNEST (cutoff determination) and GUIDANCE (clinical validation) clinical studies supporting the FDA clearance were recently published in an article in Kidney International Reports by Stuart L. Goldstein et al.¹ The multicenter prospective studies collected urinary samples from over 900 pediatric patients within 24 hours after being admitted to an Intensive Care Unit (ICU). Within the GUIDANCE clinical validation study (660 patients), a sensitivity of 72.3%, a specificity of 86.3% and a negative predictive value of 96.9% was achieved, demonstrating an excellent predictive performance for  ProNephro AKI (NGAL).

Dr. Stuart L. Goldstein, Cincinnati Children’s Hospital Medical Center, Ohio (US), stated: “The studies show a urinary NGAL (uNGAL) measurement in the first 24 hours of ICU admission performs very well to predict KDIGO stage 2/3 AKI 48-72 hours into an ICU course. The data suggests that a uNGAL cutoff of 125ng/ml can aid in the risk assessment for stage 2/3 AKI persistence or development. We provide further evidence for uNGAL utility to distinguish between functional and structural AKI in a manner that the traditional functional markers like serum creatinine (SCr) and urine output cannot.”

“The results from the EARNEST and GUIDANCE studies are very important. The data provide further evidence for the utility of uNGAL to distinguish between functional and structural AKI in a manner that the traditional functional markers of SCr and urine output cannot. Physicians now have a tool that allows for earlier clinical intervention, which has been shown to dramatically improve outcomes in patients susceptible to AKI. The clinical validation of the NGAL biomarker published by Dr. Goldstein and the GUIDANCE investigators is an exciting development for BioPorto, clinicians diagnosing AKI, and most importantly, pediatric ICU patients at risk of developing or having persistent late-stage AKI,” Dr. Tabari Baker, PhD, VP Global Medical Affairs at BioPorto, says.

US Commercial Launch of ProNephro AKI (NGAL) Progresses With High Momentum
BioPorto is currently preparing for the commercial clinical launch of ProNephro AKI (NGAL) for pediatric use in the US with its first distribution partner. The commercial launch is expected to take place later this year alongside plans to enroll the first patients for studies leading to an FDA application for adult use of the test.

“Presenting the data at the World Summit for Pediatric and Congenital Heart Surgery Congress, at ESPNIC 2024 Congress and at the European Renal Associations Congress in May and June 2024, has generated significant interest in NGAL’s performance in both predicting the development of moderate to severe AKI and as being a negative predictor of AKI. The consequences, in terms of better patient outcomes and reduced length of stay, translating into significant estimated cost savings speak volumes and are ensuring that ProNepho AKI (NGAL) interest is building with strong momentum,” Jennifer Zonderman, SVP Global Marketing and US Commercialization, says.

BioPorto will be presenting data from a multisite, cross-sectional study conducted to establish reference intervals for uNGAL in apparently healthy individuals at the Association for Diagnostic & Laboratory Medicine Congress in Chicago (US) in July 2024.

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For further information
Jennifer Zonderman, BioPorto, +1 617 694 2918, jmz@bioporto.com
Tim Eriksen, +45 4529 0000, investor@bioporto.com
Ashley Robertson, LifeSci Advisors, +1-617-430-7577, arr@lifesciadvisors.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 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 which rise in relation to kidney injury, 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.

¹ Goldsten, Stuart L., et al (2024): ”Derivation and Validation of an Optimal Neutrophil Gelatinase-Associated Lipocalin Cutoff to Predict Stage 2/3 Acute Kidney Injury (AKI) in Critically Ill Children”, KI Reports