Genedrive PLC Genedrive COVID-19 Point of Care device update (7178D)
July 01 2021 - 1:00AM
UK Regulatory
TIDMGDR
RNS Number : 7178D
Genedrive PLC
01 July 2021
genedrive plc
("genedrive" or the "Company")
Genedrive(R) COVID-19 Point of Care device update
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, provides an update on the development of its Genedrive(R)
COV19-ID Kit, a rapid Point of Care (PoC) molecular test for
SARS-CoV-2 detection, designed for the Company's Genedrive(R)
instrument.
The Company has been developing a new, best-in-class PoC
molecular workflow and assay for more than 9 months. The Company is
pleased to release the product's current performance specifications
as it moves towards the stages of formal clinical qualification and
regulatory filing. While acknowledging the longer than anticipated
development time, the Company has overcome significant technical
hurdles and also further improved performance specifications
alongside evolving marketplace requirements. Key specifications of
sensitivity, specificity, speed, ease of use, and scalability have
all been improved or addressed.
The Genedrive(R) COV19-ID Kit detects the presence of SARS-CoV-2
virus in a nasal swab. The product has been designed to provide an
ease of use appropriate for people inexperienced in molecular
testing. Positive samples are detected as quickly as 9-10 minutes,
with a negative result reported after 20 minutes if no signal is
detected.
In contrast to many competitor products, the test targets two
genes of the SARS-CoV-2 genome, and is shown to be inclusive of all
current Variants of Concern (VoCs), including the Delta variant.
The intent of a two-gene design is to provide additional robustness
to new emerging VoCs in the future. The specificity of the test
during design verification (30 positive and 30 negative contrived
clinical samples*) was 100%, with a PCR comparable limit of
detection of 10-20 copies per reaction.
The testing procedure does not require extraction of the virus
from the patient's sample. The Company has developed a proprietary
lysis buffer that is used to resuspend patient swab material, while
providing biosafety to users. Exact quantification of biosafety is
currently being assessed in an independent UK Public Health England
laboratory. A fully biosafe process would present additional or
novel opportunities and use-cases for PoC COVID-19 testing.
The simple, 4-step workflow uses an 'eye-dropper' liquid
transfer process familiar from lateral flow testing, and makes the
system appropriate for use by those without previous molecular
experience. The ease of use of the Genedrive COV19-ID test is
demonstrated at:
https://www.genedrive.com/assays/in-development-covid19-id.php
Full clinical validation on patient specimens is required for
regulatory registration and/or other emergency listings. The
Company is optimistic that this can be completed successfully and
is targeting CE marking at the end of September / early October,
with prospective patient sample collection already underway. The
Company is targeting initial product launch in Europe.
* Natural human samples spiked with heat inactivated virus at
various clinically relevant viral loads
David Budd, CEO of genedrive plc, said: "We are pleased to have
achieved significant milestones in the development of our
Genedrive(R) COV19-ID Kit and we have a product in which we are
extremely proud. Once formally validated, we believe we can make
commercial in-roads by expanding the opportunities to get a quick
and sensitive molecular test for SARS-CoV-2. The product to date
demonstrates a suite of features that have significant competitive
advantage: simplicity of workflow, an extraction free procedure,
biosafety for the user, multi-gene targeting, rapid time to result,
high sensitivity, and cost effectiveness. Whether in highly
vaccinated countries or not, COVID-19 is likely to be an illness
that we live with in the long term, necessitating rapid and
accurate testing for infection in a wide range of environments,
including outside of healthcare settings. Our commercial activities
are currently focused on engaging the appropriate commercial
partners to be in place in the autumn as the levels of infection
undoubtedly rise in many geographies."
For further details please contact:
genedrive plc +44 (0)161 989 0245
David Budd: CEO / Matthew Fowler:
CFO
Peel Hunt LLP (Nominated Adviser
and Joint Broker) +44 (0)20 7418 8900
James Steel / Victoria Erskine
finnCap (Joint Broker) +44 (0)20 7220 0500
Geoff Nash / Kate Bannatyne / Alice
Lane
Walbrook PR Ltd (Media & Investor +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Relations)
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
About genedrive plc ( http://www.genedriveplc.com ) genedrive
plc is a molecular diagnostics company developing and
commercialising a low cost, rapid, versatile, simple to use and
robust point of need molecular diagnostics platform for the
diagnosis of infectious diseases and for use in patient
stratification (genotyping), pathogen detection and other
indications. The Company has assays on market for the detection of
HCV, certain military biological targets, and has tests in
development for tuberculosis (mTB). The Company recently released a
high throughput SARS-CoV-2 assay.
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