Paraytec is collaborating with the University of Sheffield, with both focusing on the first 500 samples received from Sheffield Hospitals Trust over the last month.
Samples are being processed and subjected to analysis using Paraytec’s photonics-based detection system.
The average time to acquire test results is currently less than 120 seconds, which Braveheart deemed “a market-leading value”.
The laboratory trials data confirm the performance of Paraytec’s photonics-based test in identifying patients with an infectious viral load within the acceptable range specified by the authorities, the investor said.
The current gold standard for estimation of viral load continues to be laboratory-based PCR tests, but these detect viral RNA levels and not necessarily the presence of infectious virions, which means that many patients test positive long after they are no longer infectious.
The AIM-listed firm noted that Paraytec has thus adopted an additional comparator test developed by the University of Sheffield to verify the presence of intact virus particles.
This involves ultracentrifugation and high-resolution fluorescence microscopy to independently verify the presence of virions in clinical samples.
In parallel to the sample processing described above, the Paraytec team has been using isolated lab-grown virus to optimise the operational sensitivity of its instrument for the detection of pre-symptomatic and early-stage symptomatic virus levels.
Braveheart said it believes it will be able to confirm, within a period of four weeks, a lower limit of detection of 1,000 virions per millilitre of sample, also a market-leading value.
Paraytec will complete additional analysis of samples in the clinical pipeline to acquire robust statistical data and prepare the detailed technical specification required by regulators and producers.
The company said the team believes that the high speed and high sensitivity of its test may enable the undertaking of multiplexed ‘matrix’ testing, which combines samples from multiple people for simultaneous analysis, so that 20 parallel tests can yield individual results for up to one hundred people.
Such a test would be very helpful to the successful operation of large events, like sports or music festivals, Braveheart commented.
Paraytec will now progress to a prospective clinical validation with a larger number of patient samples and seek to obtain a CE mark for the test.
Depending on location, the prospective clinical trial is expected to take two months to complete and a further update is expected to be made by the end of April 2021, the firm said.
The Paraytec team is also exploring its use for rapid detection and identification of bacterial and viral pathogens present in patients with sepsis, a global killer of over 11mln people per year, it added.
“Our attention will now turn towards quickly commencing the final clinical trial and commercialising our product either ourselves or with a partner,” said Trevor Brown, chief executive of Braveheart, in a release.