Written evidence from Genedrive Diagnostics (PMA0030)

April 2026

Introduction

  1. genedrive plc is a UK-based life sciences company headquartered in Manchester, specialising in rapid, point-of-care pharmacogenetic diagnostic tests to guide safe and effective drug prescription in emergency and acute care settings. The company has developed two flagship tests, co-developed with, and part-funded by, the NHS:
  1. Both products are CE-IVD approved, NICE-recommended, and supported by national and international clinical guidance. They are available on the NHS procurement system (DPS) and have moved into real-world NHS use. genedrive’s technologies are currently deployed in clinical practice, including:
  1. These technologies have already demonstrated measurable patient benefit, including prevention of recurrent strokes and avoidance of irreversible hearing loss in newborn babies. As a result, genedrive has direct, end-to-end experience of the full innovation pathway, from development and clinical validation through to regulatory approval, NICE evaluation, and early NHS deployment. The company’s experience reflects not only the opportunities within the UK life sciences ecosystem, but also the practical challenges of translating proven innovation into routine NHS adoption at scale.
    The following responses are based on this direct experience of attempting to move clinically validated, NICE-recommended technologies into consistent NHS use.

Question 5. Innovation in the NHS: deployment

[Translating cutting-edge medical science into routine NHS treatment has long been recognised as a problem. Considering personalised medicine and AI as an example, what are the key systemic barriers, such as procurement processes, workforce, or IT infrastructure, that prevent or delay the deployment of proven innovations across the NHS? Which of these barriers are the most important in practice?]

  1. From genedrive’s direct experience of developing, validating, securing regulatory approval and NICE recommendation, and implementing rapid pharmacogenetic tests in NHS settings, the primary barrier is not scientific validation or clinical need. It is the absence of a clear, predictable and funded pathway from approval to routine adoption.

    genedrive has developed two rapid pharmacogenetic tests, both CE-IVD approved, NICE-recommended, and already in clinical use within the NHS. These technologies address the need for time-critical decisions in stroke and neonatal care and have demonstrated real-world patient benefit. For example, in Salford’s Hyper Acute Stroke Unit, for every two tests performed, roughly one patient is identified as requiring alternative drug prescription, therefore reducing risk of recurrent stroke, freeing hospital beds, reducing GP and outpatient follow-ups, improving patient quality of life. To date, our neonatal test has already prevented over 30 babies from anti-biotic induced hearing loss (AIHL), saving thousands in lifetime support costs, specialist appointments, and follow-up care.
  2. However, despite this, adoption remains inconsistent and dependent on local decision-making. The key systemic barriers experienced in practice are:


In practice, the most significant barriers are funding misalignment and lack of a clear national adoption route. These override all other factors.

5a) Why have previous attempts not succeeded? What would be effective?

 

[Why have previous attempts to address this not succeeded? What would be effective in addressing these problems?]

  1. From genedrive’s perspective, previous initiatives have not succeeded because they have focused on innovation generation rather than innovation adoption. There are now multiple routes supporting early-stage innovation, including regulatory pathways, pilots and NICE evaluation. However, none of these guarantee transition into routine NHS use.
  2. It is particularly concerning that while new health technology initiatives are being announced (for example the Innovator Passport for medtech companies and Innovative Licensing and Access Pathway (ILAP) for medicines and drug-device combinations), technologies that have already secured NICE recommendation still lack clear national adoption pathways. Without addressing this gap, the system risks prioritising future innovation over scaling solutions that are proven and ready today.
  3. The failure point is consistent:
  1. Effective solutions, based on genedrive’s experience, would be:

5b) Examples of good practice

 

[What are examples of good practice within the NHS of adopting these innovations that should be learned from and could be deployed more widely? What would need to happen to make that a reality?]

  1. genedrive’s experience shows that adoption works when three conditions are met:
  1. To replicate this nationally, the NHS would need:

5c) Workforce constraints

[To what extent are issues in adopting innovation in the NHS down to an overstretched workforce, particularly of clinical academics, and what needs to be done to address this?]

  1. From genedrive’s experience, workforce pressure is a contributing factor but not the primary barrier. Clinicians are generally supportive of technologies that improve patient outcomes. However:
  1. The core issue is that implementation is not resourced as a formal activity. Addressing this requires:

5d) Patient perspective

 

[Considering the patient perspective, what needs to be done in order to encourage uptake of personalised medicine in the NHS and provide a service that puts patient needs first?]

  1. From genedrive’s perspective, patient benefit is clear and immediate in both use cases:
  1. However, patient access is inconsistent. Key issues include:
  1. To support patient-centred uptake:

8. Government’s strategic approach to innovation

[What should the Government do, at a strategic level, to strengthen the feedback loop between medical research, the life sciences industry, and the NHS, so that innovations developed domestically can be adopted at scale in the NHS, and clinical insights from the NHS can feed back into R&D and the life sciences sector? What would be the most important interventions you would prioritise to improve this process? What does the NHS most urgently need to do to position itself to benefit from innovations in personalised medicine and AI?]

  1. From genedrive’s perspective, the UK has strong research, regulatory and evaluation structures. The weakness lies in translating these into adoption at scale. The most important interventions would be:

The NHS most urgently needs to become a reliable adopter of proven technologies, not just a generator of innovation.

8a) Structures and ownership

 

[Does the Government have the right structures in place to govern and oversee innovation in the NHS? Is it clear who has ownership of pushing research, innovation, and new technologies within the NHS? How effective are the links between projects like Genomics England, NIHR/MRC research, the Cell and Gene Therapy catapult, and NHS patient care? Are the Government’s target-driven strategies, like the National Cancer Plan, effective at driving innovation?]

  1. Based on genedrive’s experience there are multiple organisations involved in innovation (NICE, MHRA, NHS England, NIHR) but ownership of adoption is unclear once a product reaches approval and recommendation. This results in:
  1. genedrive’s experience shows that even after NICE recommendation, adoption remains locally determined and variable. Target-driven strategies are helpful in setting direction, but do not resolve adoption barriers unless linked to funding and accountability. Where new pathways are being introduced they are not retrospectively applied to already proven technologies.

8b) Fragmentation

 

[To what extent is fragmentation across trusts, integrated care boards, and national bodies, contributing to uneven or slow adoption of innovation? Are there any reforms that could realistically address this?]

  1. Fragmentation is a primary barrier in genedrive’s experience. It leads to:
  1. This has resulted in adoption in some regions (e.g. Scotland and Wales) adopting genedrive’s technologies, but a lack of access elsewhere. Reforms that would address this include:

Question 4. Life sciences sector

 

[How effective is the UK at translating its strengths in life sciences research into clinically validated personalised medicine and AI tools, and into its industrial base in the life sciences?]

  1. genedrive’s experience reflects a broader UK challenge - the UK is strong at developing innovation but weak at scaling it within the NHS. genedrive is a UK-developed, NHS-partnered technology with, regulatory approval, NICE recommendation and real-world NHS use. Yet we still face barriers to national adoption.

4b) Risk of companies moving overseas

 

[Is there a concern that innovative start-ups, SMEs and industrial partners in this space will move efforts overseas owing to failures in NHS procurement, support for scale-up, sluggish regulation, or other factors? If so, what could be done to address this?]

  1. From genedrive’s experience, this risk is real and driven primarily by the lack of a clear and timely pathway to NHS adoption and extended timelines between approval and scale. For SMEs, this directly impacts:
  2. Without domestic adoption, UK companies may prioritise markets with clearer reimbursement pathways and investment decisions may favour non-UK deployment. This directly impacts ability to scale, ability to raise capital and the long-term sustainability of UK-based innovation.

 

 

 

4c) Talent retention

 

[Is the UK at risk of losing leading clinical academics, researchers, and innovators working on personalised medicine and AI to other countries? What can be done to ensure the UK retains and attracts the talent needed to remain competitive in this field?]

  1. The risk to talent is linked to the same issue. If innovators cannot deploy technologies in the NHS or demonstrate commercial traction domestically then companies may relocate and talent may follow opportunities elsewhere. To retain talent, the UK must ensure that:

Closing statement

  1. genedrive’s experience demonstrates that the UK has less of a discovery problem, more a deployment problem. Proven, NICE-recommended technologies are already improving patient outcomes within the NHS, yet lack a clear pathway to national adoption. Addressing this gap would:

The priority should be to ensure that innovations developed in the UK can be routinely adopted within the NHS, at pace and at scale.