Sydney, Australia – 11 December, 2024 | NEXSEN Biotech Pty Ltd (“NEXSEN”) is setting a new standard in the diagnostic landscape with its innovative point-of-care (POC) testing solutions. Leveraging state-of-the-art nano-biotechnology, NEXSEN is addressing critical gaps in global healthcare by providing fast, accurate, and affordable diagnostic tools.
StrepSure® – Innovative Solutions for Unmet Medical Needs
A significant step for maternal and infant health, NEXSEN’s flagship product, StrepSure®, is the world's first rapid diagnostic test for Group B Streptococcus (GBS); a bacterium that is a leading cause for neonatal sepsis, meningitis, and pneumonia, which leads to significant mortality and morbidity in newborns globally.
- Advanced Technology: The StrepSure® technology employs proprietary aptamer-based nano-diagnostic technology to achieve high-specificity and sensitivity in testing.
- Rapid Results: Unlike traditional GBS testing methods that take 18–24 hours, StrepSure® delivers results within 15–20 minutes, empowering clinicians to administer timely antibiotic treatment.
- Global Impact: The product is designed for universal screening, particularly in remote and low-resource settings, where access to laboratory infrastructure is limited.
- Extending the Diagnostic Pipeline: Building on the success of StrepSure®, NEXSEN is actively developing additional diagnostic solutions for early cancer detection and kidney function:
- VetStrep®: A veterinary application of StrepSure® targeting bovine mastitis, a condition causing significant economic losses in the dairy industry.
- Creatinine Test: A rapid at-home diagnostic for kidney function, addressing the growing prevalence of chronic kidney disease globally.
- Prostate-Specific Antigen (PSA) Test: A rapid point of care solution for prostate cancer screening, offering convenience and early detection for improved patient outcomes.
Technology Overview
NEXSEN’s diagnostics leverage nanoparticle engineering and aptamer discovery to ensure precision and reliability. Key features include:
- Aptamer-Based Sensitivity: Aptamers, synthetic DNA molecules, bind selectively to specific biomarkers, minimising false positives and enhancing test accuracy.
- Lateral Flow Design: Tests are easy to use, require minimal training, and eliminate the need for cold chain logistics.
- NEXSEN.AI Platform: A proprietary AI-driven platform accelerates biomarker discovery, significantly reducing time-to-market for new diagnostic tools.
Addressing a Global Problem
With 2.9 million neonatal deaths annually, infections such as GBS remain a significant threat to maternal and infant health. GBS also contributes to complications such as pre-term births and stillbirths, particularly in low-income regions, where universal screening is unavailable.
- High Prevalence: Up to 1 in 5 pregnant women carry GBS, often unknowingly.
- Potential Impact: Widespread adoption of StrepSure® could prevent thousands of neonatal deaths and stillbirths each year.
Clinical Validation and Pathway to Market
- Clinical Trials: Northern Health, a leading Victorian healthcare provider, is conducting trials with over 3,000 patient samples to validate StrepSure® for regulatory submissions.
- Regulatory Approvals: NEXSEN is pursuing FDA (USA) and TGA (Australia) approvals, with plans to expand to the UK and European markets.
- Global Collaboration: Partnerships with institutions, such as RMIT University, Northern Health, and Design + Industry, all strengthen NEXSEN’s technological and clinical foundation.
Advancing Diagnostic Accessibility
NEXSEN’s solutions are designed with scalability in mind, ensuring accessibility across diverse healthcare ecosystems:
- Developed Markets: Hospitals, clinics, and over-the-counter use for high-quality care.
- Emerging Markets: Affordable solutions tailored for bulk, low-cost manufacturing to meet the needs of under-served regions.
- Veterinary Applications: Cost-effective diagnostics for the dairy and livestock sectors to address significant economic challenges.
A Vision for the Future
NEXSEN Biotech’s commitment extends beyond diagnostics to broader healthcare innovation. The Company’s roadmap includes expanding its diagnostic capabilities to infectious diseases, chronic illnesses, and cancer. By integrating AI and nano-biotechnology, NEXSEN is poised to transform how diseases are detected and managed.
For more information on NEXSEN Biotech and its transformative diagnostic solutions, visit nexsen.bio
About us:
About NEXSEN Biotech:
NEXSEN Biotech Pty Ltd is an Australian diagnostic company, focused on building a point-of-care testing platform utilising proprietary biomarker discovery, bioconjugation chemistry and nanoparticle engineering, to deliver material improvements in testing outcomes. The core of this innovation is the discovery and application of aptamers, a synthetic DNA molecule that binds selectively to identified particles with extreme sensitivity, ensuring the test is only testing for the target, mitigating the risk of false positives. The Company has multiple products in development, including StrepSure® for early detection of Group B Streptococcus (GBS) in pregnant women and infants, VetStrep® for detection of Bovine Mastitis, and at-home Creatinine and Prostate Specific Antigen tests (PSA).
Contact details:
Jane Morgan
Investor & Media Relations
Jane Morgan Management
jm@janemorganmanagement.com.au