DNAe Q&A with CEO Sam Reed, November 2025

Q: What are the latest updates on DNAe’s LiDia-SEQ™ platform, and the delivery of rapid, near-patient tests for bloodstream infection/antimicrobial resistance (BSI/AMR)?

A: We’re currently at a very exciting phase in the delivery of our LiDia-SEQ™ Next-Generation Sequencing (NGS)-based, sample-to-report diagnostic platform. What we’ve developed is the only device in the world that allows you to go straight from a tube sample of blood direct to sequencing and diagnosis – within the same day, in a single box solution, and with fully (automated) hands-free operation.

This offers genuinely transformative capabilities – enabled by our proprietary semiconductor sequencing and other proprietary innovations – and is a game-changer for global health in terms of its potential clinical impact. Our platform doesn’t simply report raw sequencing information, but outputs identified bacterial and fungal pathogens and genetic markers of antimicrobial resistance (AMR). This creates the opportunity to dramatically speed up diagnosis and treatment pathways for bloodstream infections (BSI) in a way that hasn’t been possible before.

Right now, our first focus is on accelerating delivery of a groundbreaking and highly sensitive test for BSI and AMR, which uses whole blood specimens to rapidly detect and identify infections that could lead to sepsis. Sepsis is one the most deadly and costly health challenges worldwide and AMR is now an urgent health crisis, so there is a compelling clinical need for this solution. We’re working hard to robustly evidence the health economics impact of our solution and put this technology into the hands of hospitals and into clinical use as soon as possible. At the moment, our team is setting up a trial with a major London hospital to validate this new BSI and AMR test, which will be our first commercially available test on the LiDia-SEQ™ platform.

Q: How do DNAe’s sequencing tests compare with conventional tests (eg. culture for bloodstream infections) in terms of speed, accuracy and clinical utility?

A: Lab-based blood culture testing for BSI – where blood samples are collected and stored to promote microbial growth then subsequently tested to identify precise organisms – are notoriously slow. For years, post-culture molecular techniques (mainly MALDI-TOF or PCR) and antimicrobial susceptibility testing have been the only available options to guide doctors towards the right treatments for individual patients, however, everyone working in hospitals today is painfully aware of its limitations. Added to the fact that it can take anything from 1 to 5 days to receive results, in many cases the culture simply fails to grow the organism and produce clinically useful results. Indeed, this highly variable process also doesn’t necessarily provide the assurance of a confident negative result – the test is simply stopped if growth doesn’t occur within a specified timeframe.

Through our technology, we’re working to avoid this culture step entirely and get accurate and actionable results into the hands of doctors within a few hours. We’re very encouraged by our early testing on spiked blood samples and small number of clinical samples, where we’ve achieved extremely accurate detection at very low concentrations of bacterial and fungal pathogens. This low limit of detection and faster time to result, combined with a comprehensive ability to detect bacterial and fungal pathogens and associated AMR profile (for bacteria), is a full suite capability that simply hasn’t been available to medical teams until now.

Q: What key attributes of DNAe’s technology make it particularly advantageous for the areas of infectious diseases, oncology and beyond? What unmet clinical needs does it address?

A: Our technology platform will answer major unmet needs across a number of key areas of clinical practice. Current genomic testing strategies today are failing to offer healthcare providers and patients what they need in terms of efficiency, accuracy and cost optimization. The lack of fit-for-purpose testing has human consequences, leading to patients suffering from ineffective treatment, complications and severe health impacts. BSI and oncology – in particular, breast cancer, lung cancer and blood cancer – are especially poorly served, with necessary diagnostic tests being far too slow, expensive or complex to run, and often conducted outside of standard care pathways.

Q: When does DNAe expect the LiDia-SEQ™ platform to be in commercial deployment?

A: Our go-to-market plan is for first phase commercial launch in early 2027, initially for research use only.

Q: What are DNAe’s priority geographies for commercial deployment and is the company currently working on regulatory approvals

A: We’re targeting commercial deployment in North America and the UK first, followed by a phased roll-out across the rest of Europe. Our regulatory priorities are FDA approval in the US, then Health Technology Assessment and MHRA authorization in the UK, and In Vitro Diagnostic Regulation (IVDR) approval for European markets. In our next phase we’ll be expanding into key regions in Asia and the Middle East.

Q: What hospitals, STAT labs and clinics is DNAe working with to validate the technology?

A: In the UK, we’re continuing to work closely with the team at our London hospital partner. In the US, we’ve appointed our key advisors and signed up a number of sites that we’ll be partnering with for sample acquisition for our development activities and future trials. We’re in active preparation for those trials and we’re on schedule to begin the sample acquisition process during 2026.

Q: What are the biggest technical challenges that DNAe has faced so far in its development pipeline, and how is your team addressing them?

A: It’s often noted within the industry that the sequencing process itself is the fastest, cheapest and easiest part of sequencing. Since the very beginning of DNAe, we’ve been focused on delivering not just another sequencer, but a fully functioned, sample-to-result diagnostic platform that can dramatically advance clinical practice and the quality of patient care.

The first technically difficult element of what we’ve accomplished is our patented semiconductor-based sequencing. This has then been the foundation for us to effectively reinvent the entire sample-to-insight pathway. Sequencing is typically multi-step, involving lots of manual processes and multiple boxes to deliver a result. What we’re doing now at DNAe is a fundamental step change – leveraging self-contained testing cartridges in a seamless workflow that completely automates the process (sample → sample preparation → library preparation → clonal amplification → sequencing → data analysis → test report), up to reporting it to the doctor. The entire workflow usually requires skilled users and specialized laboratories and laboratory equipment, but we’ve succeeding in fully automating the sample-to-result process in a single platform.

Q: What further applications for the technology do you foresee demand for from the clinical community?

A: We see major opportunities to apply our technology to rapid diagnostics for other infectious diseases, like respiratory viruses and bacterial meningitis, in oncology, particularly in breast cancer and lung cancer monitoring, companion diagnostics, pharmacogenomics and beyond. We’re working with some leading clinicians in the breast cancer field to define and develop those assays. In total, we’re evaluating 30 – 40 key target applications spanning a wide breadth of applications.

Q: How do you see the role of decentralised, fast, precision sequencing evolving within mainstream diagnostics over the next 5-10 years?

A: The technology is here and ready. Within this decade, every hospital should have access to a sequencing-capable, near-patient device that can facilitate rapid and accurate testing of patients suspected of serious infections, detect new or recurrent cancer, and enable a wide range of other tests in the patient care pathway. We envisage a swift ramp-up from early adoption to mass market deployment, and we see no barrier to these next-generation capabilities soon being available everywhere, from community hospitals to rural healthcare facilities. The portability and ease of use of our platform means that devices could be deployed on-site in a hospital, stat lab or ward – operated by non-technical staff – or could equally be used in a centralized lab setting.

There is now increasing recognition of sequencing as an essential diagnostic tool – particularly across oncology and infectious disease domains – however, none of the sequencing solutions currently on the market offer a platform that has been specifically designed for clinical use. Many of the existing sequencing products in use today were initially developed as research tools and have simply been adapted for clinical and diagnostics applications. The LiDia-SEQ™ platform is a genuine breakthrough, offering clinicians the first purpose-built solution that really addresses the specific and unique needs of near-patient testing care pathways within health systems today.

Q: What milestones or delivery should we expect from DNAe in the next 12–18 months?

A: We will shortly be announcing some exciting developments in our commercial roadmap and outlining our strategy to meet the strong demand we’re seeing for collaboration from clinical partners. We’ll also be releasing further significant datasets from our clinical studies, through peer review publication, conferences and poster presentations, and we’ll be continuing to set the foundation for successful commercialization and general market availability of our platform in 2027.