A simple, rapid PCR-Free test for detecting pathogen RNA in the field

A low cost, simple to use rapid test that provides lab-level accuracy for point of care testing, with centralised reporting to enable effective monitoring and interventions. 

Dr Ian Eastwood, Chief Technology Officer.  

Microbiology and Biochemistry BSc Hons (University of Sheffield), PhD in Molecular Biology (University of Kent). Formerly CTO of Authentix Inc. 

Quicker, more accurate accessible testing with reporting digitised to enable community monitoring and direct interventions. Rapid testing, followed by robust tracking & tracing was key to turning the tide in the current pandemic - jurisdictions that did this well saw lower loss of life, whilst those that didn't experienced higher mortality levels. However, these broadly relied on 2 technologies, a) the "gold standard" rt-PCR tests which are very accurate, but relatively slow, expensive and central lab based, plus b) simple LFD antigen tests, which are easy to use remotely, but have low accuracy.  

Our technology also has the benefits of being nucleic acid based, making it less susceptible to viral mutation and  adaptable to detect other pathogens. This is a global issue, but is not limited to the “next” pandemic - as it possible to adapt our technology to detect existing pathogens (ranging from Ebola to Yellow Fever), it is even more valuable for developing countries that suffer disproportionately from such outbreaks. With only low-cost consumables that need changing and data to drive interventions in hot-spots, this can reduce harm locally and stop spread regionally or even globally. 

The solution could serve humanity, but our target audience is National Health Authorities, Governments and key NGO’s as this solution should allow them to act more quickly and effectively, greatly reducing harm locally, regionally and internationally. In all likelihood, Health Authorities and by extension Governments will be responsible for procuring such solutions, but it is also important to let not-for-profit NGO’s know what is technically possible and how the digitisation and sharing of data can support greater testing and inspection efforts.  

During 2020, we have engaged with National Health Authorities and government bodies across Europe, plus NGO’s with more global interests and one of our intentions of applying to the Trinity Challenge was to provide us with more exposure and engagement with other international representatives to inform our solution development. 

The solution provides a fast, more accurate detection platform for multiple pathogens that can be changed in a matter of weeks in response to new threats. The information can be shared instantly, globally. Our intention would be to make the anonymised test data available to all key stakeholders to promote and enhance global co-operation and collaboration. We would also be open to linking data to other databases for the public good. 

In addition to this, as the consumables required are inexpensive and used in tiny quantities (the reagents used in a single rtPCR would enable us to do ca 100,000 field tests) and with low power requirements.   This would access to lab quality field testing to developing countries for the first time. 

Finally, the technology could also be used to test for counterfeit drugs, including vaccines to protect NGO sponsored vaccine roll-outs and also for things like counterfeit agrochemicals such as pesticides to protect crops and/or wildlife from being treated with defective chemicals.

Because this system produces a digitised result which is uploaded to the cloud, it is possible to provide remote analysis and community-wide investigation, targeting interventions more quickly and effectively. It would also allow authorities access to subject matter expertise which may not be available locally, particularly in the developing world. This would greatly reduce harm caused by outbreaks (economic and health), plus with local containment would also limit indirect negative impacts, such as mental health.  The portability and low cost of the test allows access to so many vulnerable populations, with the ability to modify test targets for specific local conditions (e.g. Tsetse, TBEV etc.), this will require the help of NGOs in terms of distribution and running testing systems.   

Ultimately, the components of the overall solution are easy to produce and/or deploy on a global scale, so any short-to-medium term impact is mainly limited by the scale of Eluceda itself. In the next one year, the aim is to build and monitor the pilot project/s with clear metrics and deliverables, Then, to enable us to increase the impact of this solution and improve the “public good”, our intention would be to collaborate with delivery partners following the initial pilot/s in years 1-3 to deliver the technology globally – either as a stand-alone solution or as constituent part of another platform. 

We have successfully utilised the base technology for a number of other (non-Health) applications and we will take a similar approach to measure impact goals here.  

We foresee two workstreams, first year/phase 1/pilot where we will be measuring accuracy (sensitivity and specificity) of the test, usability (time to test, which we can extrapolate to understand time saved/efficiency of test) and also reporting. For the second phase, years 1-3, this will be more about specific project deployment and related metrics. 

As an SME, the main barriers relate to the size of our organisation and are primarily financial, because we believe this could be a global solution. To accomplish our goals, the two specific areas we need to address the most are the automation of the system to make it even more user friendly and regulatory approvals.

We have successfully secured investment to complete the Proof of Concept and now need support in taking it to the next level. We also believe to accelerate the growth it be best to license elements of the technology to maximise its potential and we are open for this - theoretically the core technology could become the “Dolby” or “Intel” of the pathogen diagnostic world. 

York University – Paid access to laboratory space and facilities. 

Leeds University – Development of nano particles for biological detection systems and secondee.

ViBrANT – European Innovative Training Network training 15 graduate students across Europe on viral and bacterial Adhesins and virulence factors. 

Northeastern University collaboration on Trinity Challenge.

We believe it can help raise the profile of our technology, provide us with vital international connections and it can help us overcome the barriers we face. We secured funding to develop the Proof of Concept and delivered this successfully, so need help...

Automating the test, at the moment there are a number of manual preparation steps to the test, we believe this can be easily automated with a microfluidic device.

Regulatory approvals, nothing about the test is risky, but we do need to get it formally approved, we don't have this capability internally, so need to outsource and pay for this.

Finally, as an SME we don't have the reach our technology deserves, particularly with the large Health Organisation and NGO's involved in this space. Introductions could help us accelerate development immensely.

To enable us to scale for the greater good, we need help from partners with expertise in taking diagnostic devices to market (particularly regulatory approval) and potentially Pilot funding, so NGO's / Health Organisations. 

From the list of Trinity Founder Member Organisations, this would include Bill & Melinda Gates Foundation, Global Virome Project, Google, GSK, IHME, Optum, Patrick J McGovern Foundation and Reckitt, plus the other Member Organisations with a similar background.