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Periodic Reporting for period 4 - EASIVIRAL (EASIVIRAL)

Reporting period: 2020-12-01 to 2021-11-30

The key unmet health need which Altratech address in EASIVIRAL is the need to decentralise healthcare, specifically HIV viral load testing, out of central laboratories where PCR is used, and into community and point-of-care clinics.
The unmet technology need of a simple portable non-laboratory test alternative to PCR is the main technical focus of EASIVIRAL.

Early HIV virus diagnosis after infection is vital for intervention and treatment of the patient, and important for broader community and public health, in preventing further virus spread and resultant burdening of the health system. The COVID pandemic has shown the same issue quite vividly to the entire world population for SARS-CoV-2 virus. PCR labs became overloaded, and test-trace systems broke down, due to the lack of a simple point of care molecular test alternative. Society needs a solution to this ongoing problem.

The overall objective of EASIVIRAL is to address this unmet need, and provide a viable alternative molecular viral test technology to PCR, with as many of the capabilities of PCR as possible, but smaller, simpler, and more portable, and without the complexities of PCR, such as refrigeration, PCR enzymes, complicated RNA extraction and reverse-transcriptase steps requiring trained laboratory staff.
The EASIVIRAL project has culminated in significant technical success for Altratech. We have proven our target-enrichment BeadHAT and our patented Keychain PNA probes using clinical samples from HIV-positive patients by performing direct HIV RNA capture from plasma and PCR detection. Our synthetic PNA probes capture the HIV directly from the sample, without any enzymes, centrifugation, sample-prep, or reverse transcriptase steps. We are commercialising this part of the technology, due to the significant reductions in time, cost, and complexity which it offers, compared to the sample-prep and reverse transciptase steps of today’s RT-PCR tests.

Further exploitation and dissemination of our technology is underway, with early access of this technology provided to clinicians who are planning to trial it shortly for detection of SARS-CoV-2 virus with COVID-positive patient samples. We have also given invited Zoom & video presentations to US health clinicians, and plan to visit these shortly in US, when travel-restrictions are lifted. See video animation of our technology, explaining how the assay works inside a biological sample: and the list of 12 patents achieved during EASIVIRAL, giving background information on the novel assay:

In previous dissemination during the EASIVIRAL project, Altratech was chosen as a “top-25 Medtech Showcase Accelerator startup” and invited to present at the Medtech Innovator in Boston, US, in 2019. We launched our ROCAP PNA-probe design-tool at Medica 2018. Altratech also attended and presented at a number of conferences in the US and in Europe; e.g. NextGen DX in Bethesda, US; Lab on a Chip and Microfluidics, Netherlands; μTAS, Switzerland.
We have demonstrated exceptional specificity for comparative capture of double and single base-pair mismatched DNA sequences, with very high ratio of target to non-target, superior to competing technologies such as PCR & CRISPR diagnostics in the same space. This is very important in discriminating variants of a virus, which may vary by a single mutation (single base-mismatch).
We recently published Keychain PNAs for HIV: KeyChain PNA offers a purely synthetic alternative to biotinylation; it is reversible, tuneable, and programmable. KeyChain PNA will enable users to both multiplex and simplify sample preparation applications in ways which are not currently possible. This technology was developed and patented during the EASIVRAL project, by Altratech in conjunction with Dr Dan Appella in the NIH.

Overall assay end-to-end linearity of the “capacitance-versus-RNA” readout from our CMOS semiconductor sensor is excellent. This very linear response demonstrated in EASIVIRAL offers the potential of superior resolution to PCR. This will be important for future comparative testing and gene-expression studies.

We have demonstrated wafer-level PNA functionalisation of our CMOS semiconductor chips which together with the use of standard digital CMOS makes our technology easily scalable to high volume and moderate cost. The PNA, beads, and CMOS sensor in our assay are all synthetic components. Therefore there is no requirement for cold-chain storage and refrigeration.

Finally, KeyChain PNA allows core components such as magnetic microparticles, high capacitance R beads and CMOS chips to be functionalised in such a way that these do not need to be altered in any way to allow realised products to be used with future emerging viral variants. Rather, infusion with the relevant novel KeyChain PNA probes renders the technology suitable for use with the novel virus very rapidly.
This technology will have major societal benefits. It will be smaller, cheaper, and much simpler to use, enabling rapid viral detection and quantification by anyone in any place, from any sample. This will reduce the burden on healthcare system resources; will radically change the accessibility of high content genetic data; and facilitate rapid pandemic monitoring and intervention by governments and health agencies.
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