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Periodic Reporting for period 3 - EASIVIRAL (EASIVIRAL)

Reporting period: 2019-12-01 to 2020-11-30

In September 2016 WHO-Europe stated “Europe is at a critical point with HIV. New diagnoses in the European Region recently increased by 76%”. WHO urged “an accelerated people-centred response” based on taking HIV viral-load (VL) testing out of labs and into local clinics where it is most needed at point-of-care (PoC). The majority of current VL tests still involve large needles and vials of blood being transported to central laboratories for specialist PCR testing and long waits for results.

The EASIVIRAL project directly addresses this unmet need and call to action, proposing a portable HIV-VL test system to capture, purify, and detect the HIV virus from a blood sample using proven HIV-specific probes. This novel platform brings together nanobiotechnology, chemistry, and semiconductors. It will enable life-saving clinical intervention at point-of-care, immediate prescription and therapy for the patient and stops further spread of the virus.

The overall project objective project is to deliver a mass market, production ready, portable HIV test system, and with its unique combination of simplicity, robustness, reduced cost, and elimination of refrigerated reagents, to improve HIV prognosis and health outcomes, and drive SME Altratech’s growth and profitability.
All deliverables due have been submitted during this first period to EASME for their confidential review by industry experts. These summarise the first phases of the EASIVIRAL platform modular development, and fine-tuning of the assay: viral-RNA capture efficiencies from blood, purification with Peptide Nucleic Acid (PNA) probes, and characterisation of the semiconductor sensor chip. Some of this work has already been reported in an Altratech poster at the Next-Gen-Diagnostics conference in USA in August 2018.
Additionally, we have developed our own ROCAP software system for designing bespoke PNA probes. This PNA Designer software can provide probe pairs which can specifically target any genome whose sequence is available on Genbank and other similar databases. It was launched by AltraTech at Medica 2018 in Dusseldorf.
Present HIV-VL monitoring systems employ Polymerase Chain Reaction (PCR) methods, with refrigerated enzymes and reagents, and require specialised equipment and laboratory-trained staff, making them expensive, slow, and complicated. EASIVIRAL will be smaller, cheaper, and much simpler to use, enabling rapid viral detection and quantification by anyone in any place. This will have major socio-economic impact by reducing the burden on healthcare system resources.

Rapid and local availability of HIV-VL testing, in community clinics, can change the lives of people living with HIV, and will have significant societal impact. Testing can be carried out on the spot by doctors and nurses in clinics rather than by specialized technical personnel. This is hugely significant for HIV monitoring in parts of the developing world where HIV rates are high and medical facilities are basic. And it is especially significant in Eastern Europe and Central Asia where HIV infection rates are increasing recently, due to changed migration patterns, and lack of subsidies due to “donor-exit”. EASIVIRAL will not need subsidies like PCR-based methods. Its uniquely simple assay offers a long-term sustainable HIV-VL solution.

Our ‘ROCAP’ PNA-probe designer software is the first system automating the design of molecular viral diagnostic PNA probes. This will accelerate adoption of PNA’s, in research, in clinics, and in industry generally. Its combination with the EASIVIRAL platform will have significant impact beyond HIV and enable rapid viral detection of any known virus on Genbank. This will facilitate
continuous health monitoring, outside a clinical setting, at point-of-care, in communities, and ultimately in the home - the future of devolved healthcare and wellbeing.
Its ability to perform rapid and accurate genetic tests from any sample will radically change the accessibility of high content genetic data and facilitate rapid pandemic monitoring and intervention by governments and health agencies.
Altratech Medica Flyer