Advances in diagnostics can deliver huge benefits to patients and to the frontline clinicians and healthcare systems that care for them. That’s why we invest time and resources in the right projects that show significant potential to benefit health.
How we can work with you
LifeArc’s Integrated Diagnostic Team, based in Edinburgh, works with partners on diagnostics projects representing any platform or technology (e.g. molecular, protein, digital, optical, electrochemical, lateral flow etc).
As an independent charity, we can apply our diagnostic development roadmap to any technology that focuses on improving lives for people within our translational challenge areas.
We are therefore currently looking for potential diagnostics that have a realistic prospect of benefitting patients in the following areas:
- chronic respiratory infection associated with Bronchiectasis and Cystic Fibrosis
- motor neurone disease/amyotrophic lateral sclerosis
- infectious diseases (with a focus on anti-microbial resistance)
- neglected tropical disease
We want to support projects requiring assay design, diagnostic development, design verification or clinical validation. We are also keen to support the development of new RNA/DNA extraction methodologies or new diagnostic point-of-care platforms.
If you would like to partner with us on a diagnostic you are developing, please get in touch using the form below.
What we can offer
Our diagnostics development process
As a development partner, we can share our expertise at all stages of in vitro diagnostic (IVD) development. We also operate an accredited Quality Management System (QMS) in accordance with ISO 13485 (the IVD QMS standard). We have clinical development resources to support the acquisition of samples which can be used for feasibility testing or validation studies depending on your project needs. We also have experience of setting up international, multi-site clinical studies.
Our first step in working with you will be to conduct diligence of the concept and technology, and understand the scientific background. We may ask you to confirm the technical readiness level of your protocol or prototype, and we’ll work with you to determine where on the development roadmap we can offer the most support. This may include helping you in the early product development stages to independently show proof of concept, or replicate data during an initial feasibility stage.
Following on from this, or if your diagnostic is already at a more advanced development stage, we can support you by carrying out formal design control development activities which involve rigorous verification and validation testing in an appropriate sample population. During this work, we will either build – or support you in building – a design history file to support subsequent regulatory submissions.
The exact path to commercialisation of your diagnostic will be part of our discussions with you and will inform the exact development pathway that is best for you.
We provide:
- molecular diagnostics expertise, industry experience and credibility for your diagnostic development project
- a development environment certified to ISO 13485, allowing you to build a technical file for regulatory submissions
- connections to potential industry partners and diagnostic platforms – and the experience to know at which stage to approach potential commercial partners.
A unique business model to support your innovation
We work with organisations in both academia and industry who have promising diagnostic concepts that need further development work and resources.
We can provide a range of partnering options to stimulate the development and translation of research. LifeArc is not a contract research organisation. As a self-funded charity, we reduce the risk you carry in diagnostics research up to the point where you can partner with industry. We work to help the outcomes of your research get to the patient.
Our business model accepts risk by supporting your innovation. We want to reduce the time taken for a new diagnostic to market so it can have a positive patient impact. That is how we measure our return on investment.
Depending on the project, LifeArc may also receive a share of the future investment return. We negotiate the exact arrangements on a case-by-case basis.
Investment in early ventures
LifeArc’s strategy includes investing in early life science ventures, bridging the gap between academic innovation and venture funding.
Our strategy also commits us to providing investment and support for young companies developing products and technologies that can transform patients’ lives. In some cases, this involves ongoing support – particularly for science aimed at providing proof of concept and later stage translational research.
We adopt a flexible approach to supporting the science behind the rapid development of diagnostics that will benefit patients. We select the most appropriate support option depending on what stage the science around the innovation has reached and the capacity and needs of the organisation developing it. These include – but are not limited to – venture funding, collaboration (such as advice or wet/dry laboratory science), and grant funding.
Where appropriate, we can also advise academic and charity-funded researchers on writing additional funding applications.
To find out more about how we can work together, please get in touch using the form below.