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RNS Number : 4721S
Deepverge PLC
17 March 2021
17 March 2021
DeepVerge PLC
("DeepVerge" or "Company")
Microtox (R) BT Evaluation of SARS-CoV-2 from breath test with
Clinical Samples
Average virus breath condensate digital signal 9x larger than
control on nano-chip
DeepVerge (LSE:DVRG.L), the environmental and life science AI
company, announces initial data for ongoing Phase III clinical
studies on the d etection 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 (R) 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 (R) BT
nano-optofluidic chip surface with Affimer (R) 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 (R) 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 (R) 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 (R) 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 publication[vi] 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 (R) 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 (R) 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-HALE(TM) 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.
Contacts
+44 (0) 7340 055
DeepVerge plc Gerard Brandon, CEO 648
SPARK Advisory Partners
Limited Neil Baldwin/Andrew +44 (0) 113 370
(Nominated Adviser) Emmott 8974
Turner Pope Investments Andy Thacker/Zoe +44 (0) 20 3657
(TPI) Limited (Broker) Alexander 0050
About DeepVerge plc (www.deepverge.com)
DeepVerge is an environmental and life science group of
companies that develops and applies AI and IoT technology to
analytical instruments for the analysis and identification of
bacteria, virus and toxins. Utilising artificial intelligent data
analytics to scientifically prove the impact of skincare product
claims on skin microbiome for most of the top 20 global cosmetic
company clients and remotely detect and identify in real-time,
dangerous pathogens in wastewater treatment plants, drinking water,
rivers, lakes and reservoirs.
[i] 1 Femtogram is 1.0E-18 or exactly 0.000000000000000001
kilograms (SI unit). As per the prefix a gram is a thousandth of a
kilogram.
[ii] Microtox (R) BT is a rapid diagnostic human breath
condensate test that detects and identifies a range of infectious
viruses and bacteria which include SARS-CoV-2, on a single chip,
using AI, in real-time with the ability monitor disease
progression.
[iii] PCR - Polymerase Chain Reaction
[iv] Avacta Group plc (www.avacta.com)
Avacta Group is developing novel cancer immunotherapies and
powerful diagnostics based on its two proprietary platforms -
Affimer(R) biologics and pre|CISION(TM) tumour targeted
chemotherapies.
The Affimer platform is an alternative to antibodies derived
from a small human protein. Despite their shortcomings, antibodies
currently dominate markets, such as diagnostics and therapeutics,
worth in excess of $100bn. Affimer technology has been designed to
address many of these negative performance issues, principally: the
time taken to generate new antibodies and the reliance on an
animal's immune response; poor specificity in many cases; their
large size, complexity and high cost of manufacture.
[v] Aptamer Group Ltd. (www.aptamergroup.com)
Aptamer Group is a world-leading provider of bespoke nucleic
acid aptamer selection and development services, working with
partners across the pharmaceutical, biotechnology and diagnostic
sectors.
Optimers are optimized aptamer reagents. Based on
oligonucleotide molecules Optimers can bind specifically to a
target molecule to act as an antibody alternative. Their ability to
fold into distinct secondary or tertiary structures gives them high
affinity and specific binding toward targets of interest, from
small molecules to cells. They are emerging as promising
alternatives in a range of applications.
[vi] Target Product Profile " Rapid Breath Tests for the direct
and indirect detection of SARS-CoV-2"
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/966283/Breath_TPP_Final_version_v1.0.pdf
The intended use of detection tests that match these profiles
(or one that does not yet meet the specifications but looks
promising) is to aid in the triage of people with a current
SARS-CoV-2 infection by detection of SARS-CoV-2 in human samples.
Ideally, products should be designed to achieve as many of the
desired characteristics as are feasible, while still satisfying the
minimal criteria for all defined features. However, a test that
does not yet meet all these profiles may still have a role in
supporting the UK testing strategy and can be considered on a case
by case basis.
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