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| Image created by Dr. Michael J. Miller |
DeepVerge, 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 femtogrami per millilitre (“Fg/mL”) at close to 100% sensitivity and specificity on DeepVerge’s Microtox® BTii 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 PCRiii 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.”
Tracking progress of the stages of the infection
The Company notes the publicationvi by UK Medicines & Healthcare products Regulatory Agency (“MHRA”) of the “Target Product Profile Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2”. Microtox® BT satisfies many of the “Desired” and “Acceptable” criteria within the document.
Subject to the limitations of the Binding Agents’ ability to capture the virus, the Microtox® BT breath test does or does not see the virus, eliminating false positives and enabling each test the potential to predict the following conditions:
• Asymptomatic and non-infectious,
• Asymptomatic and infectious,
• Symptomatic and infectious, and
• Symptomatic and non-infectious
Point-of-Care makes it possible to track and trace the progress of the stages of any infection, including COVID19, subject to the type of pathogen (bacteria, virus, fungi or parasite) or biomarker of a disease being targeted by the Binding Agents.
AI algorithms are designed to assess the risk of steric hindrance, in the case of SARS-CoV-2, by the capture of one S-Protein and one viral particle, blocking the binding of other viral particles in the immediate vicinity.
With ability to detect and identify the binding of individual S-Proteins at Fg/mL, the viral particle can be calculated to generate a bigger shift in the laser signal. Using AI, this relates back in Fg/mL of S-Proteins which indicates a viral load for each test subject.
The joint development program of work on the PBM-HALETM breath condensate device from PulmoBioMed is ongoing using multiplex bio-marker binding agents to analyse breath for 40 other diseases which include cancer, neurodegenerative, respiratory and metabolic conditions.