Nexsen says it aims to file its RenalSure bedside test for acute kidney injury with the US Food and Drug Administration in mid-2027. It has also started a feasibility study with Austrian company GENSPEED Biotech to evaluate a second, complementary test for the condition.
Acute kidney injury is a sudden loss of kidney function. It is one of the most common complications in intensive care and major surgery. Nexsen pointed to an international study of 1,802 intensive care patients in which 57.3 per cent developed the condition, and more severe injury was linked to substantially higher hospital mortality. In a separate study of 3,101 cardiac surgery patients, 25.9 per cent developed acute kidney injury. In-hospital mortality was 6.2 per cent among those patients, compared with 0.7 per cent for patients without it.
Monitoring currently relies heavily on serum creatinine, which may not rise until kidney injury is already established. The company says this leaves clinicians needing faster assessment and more frequent monitoring to support their decisions.
RenalSure is a rapid urine-based lateral flow test. It is designed to assess kidney injury risk at the bedside without relying on a central laboratory. The FDA timetable remains subject to successful development and clinical validation. Nexsen expects its existing biobank of stored urine samples from critically ill patients to support that validation. This could reduce its reliance on recruiting new patients and speed up clinical evidence generation. The company has also registered the RenalSure and KidneySure trademarks in Australia as brands for its kidney diagnostics portfolio.
The GENSPEED study will evaluate a cartridge-based test for acute kidney injury using the Austrian company's established micro ELISA technology. GENSPEED's analyser already carries CE marking for in vitro diagnostic use. It can measure up to eight markers at once and returns results in about 15 minutes in existing applications, with less than three minutes of hands-on time.
Because the analyser already exists, Nexsen can concentrate on developing the assay and its clinical validation instead of building new hardware. The company sees RenalSure as a quick test at first contact with the patient. The GENSPEED-based assay would provide more detailed monitoring and risk assessment across hospital settings. Nexsen said offering both tests would let it serve hospitals with different testing preferences. If the feasibility results are successful, the technology could also support Nexsen's other critical care programs in traumatic brain injury and neonatal sepsis.
Nexsen managing director Mark Muzzin said the condition was a natural focus for the company."Acute Kidney Injury represents a significant opportunity for Nexsen. It's a common and serious complication in intensive care, where clinicians need timely information and kidney function can require repeated monitoring throughout a patient's stay," he said.
"We're making good progress with RenalSure® as we work towards our targeted FDA submission in mid-2027. At the same time, the GENSPEED feasibility study gives us an opportunity to pursue a complementary test, allowing us to address different hospital testing requirements.
"Our focus is on building a kidney diagnostics portfolio that meets genuine clinical needs, with the potential to expand into further critical-care applications."
Nexsen's other lead program is a Group B Streptococcus diagnostic for maternal health. It is also working on tests in traumatic brain injury, neonatal sepsis and biosecurity.