DeepVerge upbeat on initial data from phase 3 Covid-19 test studies

The AIM-traded firm said that since the third quarter of 2020, its scientists had been working under laboratory conditions with the spike protein of SARS-CoV-2 on the virus inside the containment level 3 laboratories at the University of Aberdeen.

In the studies, it said they had detected and identified the virus spike protein in quantities at 40 femtogram per millilitre at close to 100% sensitivity and specificity on the company’s ‘Microtox BT’ nano-optofluidic chip.

In addition, under the clinical trial supervision of the Royal College of Surgeons in Ireland, 40 subjects - 16 of which were independently confirmed as being Covid-19 positive with PCR tests - provided breath samples that were tested on the Microtox BT chip surface with ‘Affimer’ reagents.

The firm said the breath samples detected binding on the nano-optofluidic chip with a secondary antibody to the spike protein, which was initially selected for the isolated spike protein work.

Detection of the live virus was confirmed, indicating a nine times increase in the digital spectrum signal on the Microtox BT compared to controls of nano-optofluidic chips with binding agent, and a 19 times increase in signal with nano-optofluidic chips without binding agents.

Additional digital background noise was indicated due to the non-specific binding of the antibody.

Further data would be required to confirm the same high sensitivity and specificity was achieved on breath test clinical trials, which DeepVerge said was underway.

“DeepVerge scientists have transformed its AI based water contamination detection system, developed over five years for e.coli, into the breath condensate Microtox BT unit,” said chief executive officer Gerard Brandon.

“Having successfully completed phase 1 testing on the spike protein and phase 2 studies with SARS-CoV-2 virus in the safety of containment level 3 laboratories, the initial results of phase 3 real-world clinical studies in Covid-19 patients have reached a major milestone with the demonstration that our Microtox BT can deliver results in under 60 seconds from breath samples.”

Brandon said the requirement for the UK Target Product Profile Rapid Breath Test required 150 confirmed positive samples and 250 confirmed negative sample

“. Additional supervised breath test clinical trials from a larger group is expected to provide sufficient data to meet the desired and acceptable criteria in the Target Product Profile to roll out the Covid-19 and other pathogen breath tests later this year.”

At 1346 GMT, shares in DeepVerge were upm 9.26% at 37.15p.