Braveheart Inv Regulatory News (BRH)

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4 May 2021

Braveheart Investment Group plc

("Braveheart" or the "Group")

Further update re Paraytec Limited

Further to the announcement on 26 March 2021, Braveheart Investment Group plc (AIM: BRH), is pleased to provide an update concerning progress to develop a COVID-19 test that Paraytec Limited ("Paraytec" or the "Company") is working on in conjunction with the University of Sheffield.

In clinical validation studies, a total of 39 COVID-19 positive and 13 COVID-19 negative patient nasal swab samples have been used in a comparator PCR test to determine the viral load in each sample. Virus containing samples corresponding to the load distribution have been transferred to Paraytec's newly developed Viral Transport Medium to test the laboratory performance of Paraytec's photonics-based test. Using a maximum cycle threshold (Ct) value of 37, Paraytec's q-PCR testing regime has a sensitivity and specificity of 97.4% and 100% respectively. In the laboratory, the Paraytec test achieved 94% sensitivity and 100% specificity. Importantly, these results correspond to clinical samples with viral loads of approximately 100,000 virions per millilitre or less.

This outcome is important because it demonstrates the ability of the Paraytec test to identify people with relatively low viral loads - many of whom would be asymptomatic individuals or those with early stage infection. The results demonstrate the potential performance advantage of the Paraytec test over lateral flow tests, which have only shown high levels of sensitivity in clinical samples with relatively high viral loads (typically, 500,000 virions per millilitre and higher).

The team will now take this data to commercial partners and potential licensees, who have requested this information. As previously stated, over the next three months, Paraytec plans to conduct a longitudinal clinical study (where patients are monitored over time). Paraytec is seeking manufacturers and licensees to take the product to the global market. With regard to the first product manufacture, Paraytec now expects that it will be approximately six months after contractual engagement with a manufacturer.

The Paraytec test is based on the principle of rapid labelling of a pathogen (in this case the SARS-Cov2 virus) with a light-emitting molecule. Importantly, this work has demonstrated the broader capabilities of the photonics-based platform to give a quick and quantified test result. It may be used with various labelling chemistries such as aptamers or antibodies, depending on the user's needs and this enables adoption of this technology for the identification of other pathogens, or the new variants of COVID-19 that are beginning to emerge worldwide. 

Prof Smythe, leading the team at the University of Sheffield, commented: "We are very pleased with this latest data, which is based on the most recent design iteration of our signal generation module. Further improvements in performance sensitivity are already in the design pipeline for the sample acquisition element of the test."

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