BioPorto's Kidney Test Advances, Targeting Major U.S. Adult Market

COPENHAGEN, DENMARK – March 18, 2026 – Danish diagnostics firm BioPorto A/S announced today a significant step forward in its mission to improve care for critically ill patients, revealing positive preliminary results from its U.S. study on a novel test for adult Acute Kidney Injury (AKI). The findings provide a strong foundation for the company's planned Pre-submission to the U.S. Food and Drug Administration (FDA) by the end of this month.

The announcement signals growing confidence that its flagship biomarker, Neutrophil Gelatinase-Associated Lipocalin (NGAL), can provide an early warning for kidney damage in adults, a feat that could unlock a substantial market and change a long-standing paradigm in critical care diagnostics. This progress follows the company's successful FDA clearance for a pediatric version of the test in late 2023.

A Key Milestone in a Strategic Push

BioPorto confirmed the successful completion of its preliminary analysis for the U.S. adult NGAL Cutoff Study, which was designed to evaluate the test's performance in assessing the risk of AKI. According to the company, the analysis showed positive results that support the study's primary endpoint, a crucial indicator of a clinical trial's success.

“This analysis is a major milestone for BioPorto,” stated CEO Carsten Buhl in the company's announcement. “Support for our primary endpoint gives us the confidence to proceed with an FDA Pre-submission by the end of Q1.”

The Pre-submission process allows BioPorto to engage with the FDA proactively, seeking feedback on its regulatory strategy and the design of a larger, forthcoming Validation Study. This step is essential for de-risking the final leg of the regulatory journey and ensuring the subsequent clinical trial is optimized to meet the FDA's rigorous standards.

The positive adult data mirrors the findings from the company's previous pediatric studies, which paved the way for the 510(k) clearance of its ProNephro AKI (NGAL) test for patients aged 3 months to 21 years.

“We are encouraged with the results from our interim analysis for the clinical performance of the BioPorto assay,” commented Dr. Prasad Devarajan, BioPorto’s Senior Medical Director. “The analysis reinforces our confidence that, upon completion of the study, the results provide strong support for the value of NGAL as a biomarker for identifying the risk of AKI in critically ill adults.”

The Silent Threat of Acute Kidney Injury

The push for a better diagnostic tool is driven by the severe and widespread challenge posed by Acute Kidney Injury. AKI is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. It causes a build-up of waste products in the blood and makes it hard for kidneys to keep the right balance of fluid in the body.

The condition is alarmingly common, particularly in hospital settings. It affects up to 1 in 5 hospitalized adults and more than 50% of patients in intensive care units (ICUs). The consequences can be dire, leading to prolonged hospital stays, an increased risk of developing chronic kidney disease, and significantly higher mortality rates.

A major hurdle in treating AKI is the inadequacy of current diagnostic methods. For decades, clinicians have relied on measuring serum creatinine levels and urine output. However, serum creatinine is a notoriously late indicator; levels may not rise until 24 to 72 hours after significant kidney damage—up to a 50% loss of function—has already occurred. This delay closes the critical therapeutic window where early intervention could prevent irreversible damage and improve patient outcomes.

NGAL: An Early Warning System for the Kidneys

BioPorto’s NGAL test is designed to overcome this fundamental diagnostic gap. NGAL is a protein that is released into the blood and urine in large quantities by kidney tubule cells within just 2 to 6 hours of injury. This makes it a direct and immediate biomarker of kidney stress, offering a real-time signal of distress long before serum creatinine levels begin to change.

By providing an earlier and more accurate risk assessment, the NGAL test could empower physicians to:

• Identify at-risk patients sooner, allowing for proactive management.
• Implement kidney-sparing interventions, such as adjusting medications or managing fluid levels more precisely.
• Potentially reduce the severity of AKI, leading to better patient outcomes and lower healthcare costs associated with dialysis and extended ICU stays.

The successful application of this technology in the vast adult patient population would represent a significant advancement in critical care medicine, addressing a major unmet clinical need.

Navigating the Path to the U.S. Adult Market

With positive preliminary data in hand, BioPorto is executing a methodical regulatory strategy honed during its successful pediatric clearance process. The planned Pre-submission is a testament to this experience, aimed at fostering a collaborative dialogue with the FDA to streamline the path forward.

Following feedback from the agency, the company will initiate its pivotal Validation Study, which will provide the comprehensive clinical evidence needed for a final 510(k) submission. BioPorto has previously stated its goal is to file for adult clearance in 2026, which could position the test for commercial launch in the U.S. as early as 2027.

The market opportunity is substantial. The global AKI diagnostics market was valued at over USD 1.2 billion in 2024 and is projected to nearly double by 2033, driven by an aging population and the rising incidence of chronic diseases that predispose patients to kidney complications. Successfully entering the U.S. adult segment would be transformative for BioPorto, aligning with its long-term ambition to exceed USD 100 million in revenue by 2029.

Despite the significant investment required for the adult indication—estimated at USD 15-20 million between 2024 and 2026—the company confirmed that this week's announcement does not alter its current financial guidance for 2026. This suggests the milestone was factored into its strategic planning, reinforcing the company's focused and deliberate approach to expansion. The initiation of the pivotal Validation Study, pending regulatory feedback, will mark the next major chapter in BioPorto's quest to establish a new standard of care for one of modern medicine's most pressing challenges.