DNAe Unveils Early Access Program for LiDia‑SEQ™: Hospital Teams Invited to Trial DNAe's Flagship Tests and Preview DNAe's Innovative NGS Diagnostic Platform
- New priority program opens up exclusive opportunities for collaborative research on transformative clinical potential of DNAe's flagship tests and to gain preview of breakthrough LiDia-SEQ™ platform
LONDON and CARLSBAD, Calif., Dec. 11, 2025 /PRNewswire/ -- DNAe, the Next-Generation Sequencing (NGS) company developing a transformative fully automated, sample-to-report diagnostics platform, today unveils a new Early Access Program, offering clinical partners an exclusive pre-launch preview of the results generated by the company's world-first tests* – including the BSI/AMR Test targeting bloodstream infections and antimicrobial resistance – and the opportunity to later participate in pilot placements of DNAe's breakthrough Next Generation Sequencing (NGS)-based diagnostic system – LiDia-SEQ™.
With DNAe's LiDia-SEQ™ platform now at an advanced stage of development, DNAe is inviting formal expressions of interest from hospitals, clinics and research institutions, and anticipates significant engagement from teams focused on sepsis, infectious diseases, critical care, and cancer. Expressions of interest are now being accepted on DNAe's website: https://www.dnae.com/early-access-program.
The Early Access Program (EAP) is expected to generate high-quality, high-impact published data demonstrating the performance and potential health system benefits delivered by DNAe's tests and proprietary NGS-based technology platform – the world's first diagnostic platform set to fully automate the sample-to-result process within a single device, delivering results in just a few hours.
Phase One of DNAe's Early Access Program will begin in April 2026 and offer participating sites exclusive access to the BSI/AMR assay – the bench version of the BSI/AMR test – with program participants able to send whole blood samples and culture isolates to DNAe for testing (intended for research use only). Further tests will target other infectious diseases and oncology applications.
The second phase of the program will see on-site pilot placement of prototype LiDia-SEQ™ systems in select hospitals in advance of general commercial availability, enabling clinical teams to run DNAe's BSI/AMR test within the hospital.
The launch of DNAe's EAP creates a unique opportunity for priority partners to conduct collaborative research studies on the transformative potential of DNAe's tests, including its BSI/AMR Test – the flagship application on the LiDia-SEQ™ technology platform. Potential areas of exploration include evaluations of the BSI/AMR test versus today's standard of care – blood culture and other currently available clinical tests – plus modeling the potential impact on clinical outcomes and health economic benefits. Further studies are expected to explore the impact of the platform's rapid NGS-based diagnostic capabilities on healthcare-associated infections, infection prevention and control, and outbreak identification and response, among other applications.
DNAe's BSI/AMR Test is a whole blood sample test that enables the detection of bacterial and fungal pathogens, along with key antimicrobial resistance markers for bacterial pathogens, at clinically relevant concentrations (≤3 CFU/mL and associated AMRs). The initial test is expected to offer a comprehensive testing menu of around 7,200 bacteria, with 30 associated AMRs, and 750 fungi. This breakthrough test will be the first to be commercially launched on the LiDia-SEQ platform and is poised to dramatically accelerate diagnostic and treatment pathways for bloodstream infections and the prevention of sepsis. DNAe is also working on a range of tests for circulating tumor DNA in blood.
Samuel Reed, CEO of DNAe, comments: "Our Early Access Program launch is a pivotal moment in the evolution of the LiDia‑SEQ™ platform and the delivery of DNAe's commercial roadmap. By offering pioneering hospitals and clinical partners first-hand experience of the transformative results that can be generated by our flagship tests – ahead of commercial availability – what we are offering is an unprecedented opportunity to preview the future of NGS diagnostics. We anticipate very strong interest from forward-thinking teams looking to evaluate game-changing, real‑world applications and accelerate the adoption of innovative solutions that will transform infection management worldwide."
DNAe's rapid, NGS-based LiDia-SEQ™ diagnostic platform offers low limit of detection and dramatically faster time-to-result than current lab-based testing, delivering near-patient NGS testing capabilities to medical teams working across hospitals, STAT labs and clinics. By detecting bacterial pathogens and associated AMR profile, plus fungal pathogens directly from whole blood samples – at the point-of-need and within hours versus days – DNAe's technology promises to facilitate rapid and accurate testing of patients suspected of serious infections. DNAe's other assays usher in unprecedented testing capabilities across key clinical areas including infectious diseases, cancer detection and more.
DNAe recently presented brand-new data on its novel testing applications in oncology monitoring, bloodstream infection detection and combatting antimicrobial resistance at the Association for Molecular Pathology (AMP) Annual Meeting and Expo 2025 in Boston. The poster presentations are available for download from the DNAe website.
DNAe's Early Access Program: Key Timelines
- December 2025: Expressions of interest and engagement with potential participating hospitals
- April 2026: Start of EAP Phase One testing on whole blood samples and culture isolates
- Date TBC: Prototype LiDia-SEQ™ systems placed in select hospitals to run BSI/AMR test
About DNAe (www.dnae.com)
DNAe is commercializing its pioneering semiconductor sequencing technology for healthcare applications where rapid point-of-need diagnostics are of critical need, including infectious disease and cancer testing and monitoring. It is developing the LiDia-SEQ™ system, a user-friendly, direct-from-specimen platform that performs genomic analysis on a microchip, to provide comprehensive, actionable information to clinicians in a matter of hours, versus days. DNAe's initial focus is on infectious disease diagnostics, starting with a groundbreaking test for bloodstream infections (BSI) and antimicrobial resistance (AMR), which uses whole blood specimens to directly detect and identify infections that lead to sepsis. This will provide clinicians with actionable information to help select the appropriate antibiotics to treat the disease. A pipeline of follow-on tests is in development for viruses and cancer testing and monitoring. DNAe has received 'Breakthrough Device' designation from the US Food and Drug Administration (FDA) for its pioneering platform and first assay.
A private company, DNAe has operations in London, UK and Carlsbad, CA, USA. DNAe has received funding from The Biomedical Advanced Research and Development Authority (BARDA)** to develop its diagnostic platform, initially for antimicrobial-resistant infections. DNAe's major shareholder is Genting Berhad, a Malaysian-based global investor with a growing portfolio of investments in cutting-edge life sciences companies.
*Disclaimer: The DNAe BSI/AMR test and LiDia-SEQ™ platform are under development and have not been approved or cleared by the FDA or any other regulatory agency.
**This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.
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