EU-funded researchers have developed an ultrasensitive test to rapidly, accurately and cost-effectively diagnose disease, underpinned by innovative biosensing technology that could help combat the COVID-19 pandemic, HIV and cancer.

The EU’s NATURALE CG project is opening new avenues for the early detection of many infectious diseases, as well as non-communicable conditions, by identifying their specific molecular signatures. Funded by the European Research Council, the project’s transformative approach is based on versatile biosensing platform technology using novel bioengineered nanomaterials.

‘Our ultrasensitive test outperforms the current gold standard benchmark by a factor of 20 and has a wide dynamic range that allows both detection at the very early stage of infection and ongoing immune response monitoring,’ says the project’s principal investigator, Molly Stevens at the Imperial College of Science, Technology and Medicine in the UK.
Similar to a pregnancy test, the prototype paper-based lateral flow assay is particularly suitable for disease diagnosis and monitoring at point of care in resource-limited settings, especially when it is difficult to access standard laboratory testing facilities. Upon exposure to a patient’s fluid sample, such as urine, blood or saliva, the test paper yields a visible colour signal in response to the presence of specific biomarkers – the molecular signature or fingerprint of a disease.
By incorporating different nanoparticles and bioengineered materials, the same biosensing technology can be adapted for a broad range of diagnostic applications for different diseases.

Point-of-care test for infectious diseases and cancer

The NATURALE CG team are now experimenting with combining the biosensing tests with smartphone technology, using the ubiquitous mobile devices as a platform to analyse, store and communicate diagnostic and monitoring results to patients and healthcare providers. Coupled with smartphone geolocation capabilities, this could become an essential tool for surveillance and monitoring of disease epidemics and pandemics like COVID-19.

To that end, Stevens’ team is actively working on the development of an ultrasensitive point-of-care test for COVID-19 detection, supported by a new grant from the European Institute of Innovation and Technology.
‘It is difficult to put a timeframe on when this will be ready, but we have previously run a small-scale demonstration of the technology by developing and applying a point-of-care test for antibodies against the Ebola virus in human survivors in Uganda. Our i-Sense centre also has strong links with partners in South Africa looking to map HIV test results with smartphone technologies,’ Stevens says.

In parallel, the ERC-funded sister project Nanozymes has laid the foundations for the potential commercialisation of a novel point-of-care device for the early diagnosis of HIV.

‘Mobile health approaches have huge potential to impact healthcare provision, especially in remote, resource-limited areas where transformative technologies are urgently needed,’ Stevens says. ‘The potential impact is tremendous considering the significant numbers affected by disease. To give just one example, about 38 million people are living with HIV, and 770 000 people died from AIDS-related illnesses in 2018 alone.’

Stevens and her team are also working on tests for non-communicable diseases, which account for 63 % of global deaths. The researchers are collaborating with the Massachusetts Institute of Technology in the US on the co-development of a transformative test for detecting cancer in vivo. The test uses injectable clusters of catalytic gold nanoparticles that disassemble in the presence of cancer. The nanoparticles are cleared through the patient’s urine and cause the paper to change colour if cancer is present, generating a result in under one hour.

Democratising healthcare

‘We will further develop this versatile and modular approach to enable rapid diagnostics of a variety of diseases,’ Stevens says. ‘One of the end goals of our research is to democratise healthcare by designing therapeutic and diagnostic technologies that, while being at the cutting-edge of medicine, remain accessible to wide sectors of the population irrespective of the resources available to them. To this end, we are developing techniques that require minimal specialised staff or equipment to deliver effective and timely results.’

In parallel to developing the biosensing technology, the NATURALE CG researchers have significantly advanced the application of Raman microspectroscopy as a powerful imaging and molecular fingerprinting tool for nanomaterials and biomaterials. The technology provides unprecedented insight into cell and tissue structures, enabling the detailed characterisation of molecules by detecting their vibrational, rotational and other states.

This significant innovation in molecular-characterisation techniques has applications not only in biosensing but also in regenerative medicine, enabling biomaterials to be developed that more closely mimic native tissues such as cartilage or heart muscle. This, in turn, is opening potential therapeutic pathways to treat heart disease by promoting cardiac-tissue regeneration using biomaterials with improved mechanical properties, biocompatibility and conductivity.
Other innovations include the co-development of ‘nanoneedles’, a minimally invasive and fast-acting nanotechnology for drug delivery capable of injecting medication directly into targeted cells.

‘These technologies provide versatile platforms for which we continue to uncover potential applications,’ Stevens concludes.



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