Average virus breath condensate digital signal 9x larger than control on nano-chip
York, United Kingdom (GLOBE NEWSWIRE) - DeepVerge (LSE:DVRG.L), the environmental and life science AI company, announces initial data for ongoing Phase III clinical studies on the detection of SARS-CoV-2 on breath samples and identification of confirmed COVID19 positive patients.
Since Q3 2020, DeepVerge scientists have been working under laboratory conditions with the Spike Protein ("S-Protein") of SARS-CoV-2 on the SARS-CoV-2 virus inside the Containment Level 3 ("CL3") laboratories at the University of Aberdeen. In these studies, they have detected and identified the virus S-Protein in quantities at 40 femtogram[i] per millilitre ("Fg/mL") at close to 100% sensitivity and specificity on DeepVerge's Microtox® BT[ii] nano-optofluidic chip.
In addition, under the clinical trial supervision of the Royal College of Surgeons, Ireland, 40 subjects, 16 of which were independently confirmed as COVID19 positive with PCR[iii] tests, provided breath samples that were tested on the Microtox® BT nano-optofluidic chip surface with Affimer® reagents ("Avacta Group")[iv] and Optimers ("Aptamer Group")[v] together the ("Binding Agents").
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 9 times increase in the digital spectrum signal on the Microtox® BT when compared to controls of nano-optofluidic chips with binding agent; and 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 is required to confirm the same high sensitivity and specificity is achieved on breath test clinical trials which are underway.
Gerard Brandon CEO of DeepVerge plc commented:
"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. Having successfully completed Phase I testing on the Spike Protein and Phase II studies with SARS-CoV-2 virus in the safety of CL3 laboratories, the initial results of Phase III real-world clinical studies in COVID19 patients have reached a major milestone with the demonstration that our Microtox® BT can deliver results in under 60 seconds from breath samples.
"The requirement for the UK Target Product Profile ("TPP") Rapid Breath Test requires 150 confirmed positive samples and 250 confirmed negative samples. 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 TPP to roll out the COVID19 and other pathogen breath tests later this year."
Please click on the PDF to view the full announcement http://www.rns-pdf.londonstockexchange.com/rns/6108S_1-2021-3-17.pdf.
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