Nexsen advances kidney diagnostics program toward mid-2027 FDA submission
Nexsen Limited (ASX:NXN) has updated the market on its kidney diagnostics program, which is initially targeting Acute Kidney Injury (AKI). The Company’s proprietary RenalSure® bedside test is progressing towards a targeted US FDA submission in mid-2027, subject to successful development and clinical validation.
Alongside this, Nexsen has commenced a new feasibility study with Austrian diagnostics company GENSPEED Biotech GmbH (“GENSPEED”) to evaluate a complementary cartridge-based AKI test. A defined regulatory target gives investors a clear milestone to track.
The announcement of 6 November 2026 highlighted four points:
- 149 million AKI tests annually across the US, UK and Australia
- A global AKI diagnostics market worth US$1.03 billion in 2026
- AKI affecting 57% of ICU patients in a major international study
- GENSPEED technology delivering results in approximately 15 minutes in existing applications
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A large unmet need in intensive care
What the clinical data shows
AKI is a sudden loss of kidney function and one of the most common complications in intensive care and major surgery. The announcement cites two studies that show how often it occurs.
An international study of 1,802 intensive care patients found that 57.3% developed AKI, with more severe AKI linked to substantially higher hospital mortality. In a study of 3,101 cardiac surgery patients, 25.9% developed AKI, and in-hospital mortality was 6.2% for those with AKI compared with 0.7% for those without.
Current monitoring relies heavily on serum creatinine, which may not rise until kidney injury is already established. This creates a need for faster assessment and more frequent monitoring to support clinical decisions.
Sizing the commercial opportunity
Nexsen describes the commercial opportunity as underpinned by repeat testing throughout a patient’s ICU stay. Based on estimated ICU admissions and testing frequency, the addressable opportunity across the US, UK and Australia is approximately 149 million tests annually, according to a Frost & Sullivan market report included in the Prospectus dated 29 August 2025. That figure assumes an average ICU stay of four days and six tests a day.
The global AKI diagnostics market is estimated at approximately US$1.03 billion in 2026, and is forecast to reach US$1.71 billion by 2033, per Grand View Research. These estimates cover the global category, not Nexsen’s addressable share.
| Metric | Figure | Source |
|---|---|---|
| Addressable annual tests (US, UK, Australia) | Approximately 149 million | Frost & Sullivan, Prospectus dated 29 August 2025 |
| Global AKI diagnostics market, 2026 | Approximately US$1.03 billion | Grand View Research |
| Global AKI diagnostics market forecast, 2033 | US$1.71 billion | Grand View Research |
| AKI rate in ICU patients | 57.3% of 1,802 patients | AKI-EPI study (Hoste et al., 2015) |
Kidney disease affects an estimated 850 million people worldwide. Nexsen sees potential to apply the clinical and development experience gained in AKI to chronic kidney disease over time.
What AKI means for investors
For readers new to the area, AKI is a sudden loss of kidney function. It is common in intensive care and major surgery.
A rapid bedside test matters because clinicians need timely information to make decisions, and kidney function can require repeated monitoring throughout a patient’s stay. That repeat monitoring is the basis of the commercial case: a test used several times per patient generates recurring test volumes rather than one-off use.
Two tests, one kidney diagnostics portfolio
RenalSure® at the bedside
RenalSure® is Nexsen’s proprietary rapid, urine-based lateral flow diagnostic, designed to assess kidney injury risk at the bedside without relying on a central laboratory. Development is progressing towards a targeted US FDA submission in mid-2027, subject to successful development and clinical validation.
Nexsen’s existing biobank of stored urine samples from critically ill patients is expected to support clinical validation. This could potentially reduce reliance on new patient recruitment and accelerate the generation of clinical evidence.
The Company has also registered the RenalSure® and KidneySure® trademarks in Australia.
The same ISO 13485 quality system that Nexsen certified for its StrepSure test is designed to be reused across other products, which is relevant to how quickly the kidney programs can move through regulatory review.
GENSPEED feasibility study
The feasibility study will evaluate a complementary cartridge-based AKI test using GENSPEED’s established micro-ELISA technology. GENSPEED’s CE-IVD marked analyser offers the following in existing applications:
- Measurement of up to eight markers simultaneously
- Results in approximately 15 minutes
- Less than three minutes of hands-on time
Figure 1 in the announcement shows the GENSPEED multiplex test chip and the GENSPEED analyser.
By leveraging an established analyser, Nexsen can focus its development efforts on the AKI assay and clinical validation, rather than developing new hardware. RenalSure® supports quick bedside testing at first contact, while the GENSPEED-based assay provides more detailed monitoring and risk assessment across hospital settings.
Nexsen says different hospitals have different preferences, so offering both tests creates a flexible, end-to-end renal testing portfolio. Subject to successful feasibility results, the technology could also support future diagnostic applications across Nexsen’s existing critical-care programs, including traumatic brain injury and neonatal sepsis.
Traumatic brain injury and neonatal sepsis entered the pipeline through Nexsen’s Hong Kong R&D facility, which is backed by a non-dilutive HK$6 million grant and university collaborations.
Mark Muzzin, Managing Director
“We’re making good progress with RenalSure® as we work towards our targeted FDA submission in mid-2027…”
What happens next for Nexsen
Two items stand out for investors tracking the program:
- RenalSure® US FDA submission: targeted for mid-2027, subject to successful development and clinical validation, with Nexsen progressing development.
- GENSPEED feasibility study: commenced, with the results determining whether the complementary AKI test, and potential applications in traumatic brain injury and neonatal sepsis, proceed.
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