Nexsen Targets Mid-2027 FDA Submission for RenalSure® and Begins GENSPEED Feasibility Study

Aditi Sarkar

06 November 2026 11:23 AM AEDT

Nexsen Targets Mid-2027 FDA Submission for RenalSure® and Begins GENSPEED Feasibility Study

Image Source: Krish Capital Pty Ltd

You are reading a free article with opinions that may differ from the recommendation given by Kalkine in its paid research reports. Become a Kalkine member today to get access to our research reports, in-depth technical and fundamental research. Learn more

Start Your Free Trial Now!

Nexsen Limited (ASX:NXN) has disclosed progress on its kidney diagnostics program, with its proprietary RenalSure® bedside test advancing toward a targeted US FDA submission in mid-2027 and a new feasibility study commenced with Austrian diagnostics company GENSPEED Biotech GmbH to evaluate a complementary cartridge-based acute kidney injury test.

Key Points

RenalSure® is a rapid, urine-based lateral flow diagnostic targeting a US FDA submission in mid-2027, subject to successful development and clinical validation.
Nexsen has commenced a feasibility study with GENSPEED Biotech GmbH to evaluate a cartridge-based AKI test using established micro-ELISA technology capable of measuring up to eight markers simultaneously.
The addressable opportunity across the US, UK, and Australia is approximately 149 million AKI tests annually, with the global AKI diagnostics market estimated at approximately US$1.03 billion in 2026 and forecast to reach US$1.71 billion by 2033.
Nexsen has registered RenalSure® and KidneySure® trademarks in Australia to establish its kidney diagnostics portfolio brands.

RenalSure® Development and Clinical Validation Progress

RenalSure® is designed to assess kidney injury risk at the bedside without relying on a central laboratory. Development is progressing toward a targeted US FDA submission in mid-2027, subject to successful development and clinical validation. According to the filing, Nexsen's existing biobank of stored urine samples from critically ill patients is expected to support clinical validation, potentially reducing reliance on new patient recruitment and accelerating the generation of clinical evidence. The company has also registered the RenalSure® and KidneySure® trademarks in Australia.

GENSPEED Feasibility Study Details

Nexsen has commenced a feasibility study with GENSPEED Biotech GmbH to evaluate a complementary cartridge-based AKI test using the company's established micro-ELISA technology. GENSPEED's CE-IVD marked analyser can measure up to eight markers simultaneously, delivering results in approximately 15 minutes in existing applications, with less than three minutes of hands-on time. The filing states that 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.

Acute Kidney Injury Market and Clinical Context

According to the filing, an international study of 1,802 intensive care patients found that 57.3% developed AKI. In a separate study of 3,101 cardiac surgery patients, 25.9% developed AKI, with in-hospital mortality of 6.2% for those with AKI compared with 0.7% for those without. The commercial opportunity is described as being underpinned by repeat testing throughout a patient's ICU stay. 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, according to Grand View Research cited in the filing.

Download Free Report – Explore 3 Stock Ideas & Industry Insights

Unlock 3 stock ideas and key industry insights in our free report. This information is general in nature and does not consider your personal objectives, financial situation, or needs. It is not financial advice.

All investments involve risk—consider independent advice before making any investment decisions.

View 3 Research Reports

Disclaimer:

This article (“Article”) has been prepared by Kalkine Pty Limited (ABN 34 154 808 312) (Australian financial services licence number 425376) (“Kalkine”) and its related bodies corporate who are authorised to provide general financial product advice. Kalkine.com.au and its associated pages are published by Kalkine.

Any information/advice provided in this article is general in nature and does not take into account your objectives, financial situation or needs. You should therefore consider whether the information is appropriate for your objectives, financial situation and needs before acting upon it.

There may be a Product Disclosure Statement, Information Memorandum or other offer document (“Offer Document”) for the securities or other financial products referred to in Kalkine articles. You should obtain a copy of the Offer Document and consider it before making any decision about whether to acquire the security or financial product.

Kalkine strongly recommends that you seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) before acting on any advice/information in this Article or on the Kalkine website. Not all investments are appropriate for all people.

The information in this Article and on Kalkine website has been prepared from a wide variety of sources, which Kalkine, to the best of its knowledge and belief, considers accurate. Kalkine has made every effort to ensure the reliability of the information contained in its articles (including this Article), newsletters and websites. All information represents our views at the date of publication and may change without notice.

The information in this Article does not constitute an offer to sell securities or other financial products or a solicitation of an offer to buy securities or other financial products.

Kalkine does not issue, sell or deal in any financial products.

This Article may contain information on past performance of particular investments. Please note past performance is neither an indicator nor a guarantee of future performance.

To the extent permitted by law, and excluding any dishonesty or gross negligence by Kalkine, Kalkine disclaims and excludes all liability for any direct, indirect, implied, punitive, special, incidental or other consequential loss or damage arising from the use of or reliance on this Article, the Kalkine website and any information published on the Kalkine website without any warranties or representations by Kalkine to you. To the extent the law prohibits or limits this exclusion, Kalkine limits its liability to the resupply of services.

Please also read our Terms & Conditions and Financial Services Guide for further information.

Employees and/or associates of Kalkine and its related entities may hold interests in the securities or other financial products covered in this Article or on the Kalkine website. Any such employees and associates are required to comply with certain safeguards, procedures and disclosures as required by law.

Some of the images/music that may be used in the Article are copyright to their respective owner(s). Kalkine does not claim ownership of any of the pictures displayed/music used in the Article unless stated otherwise. The images/music that may be used in the Article are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source wherever it was indicated or was found to be necessary.

Kalkine Media Pty Ltd, an affiliate of Kalkine Pty Ltd, may have received, or be entitled to receive, financial consideration in connection with providing information about certain entity(s) covered on its website.