Genedrive PLC Point-of-Care solution to detect SARS-CoV-2 virus (8438C)
October 22 2020 - 1:00AM
UK Regulatory
TIDMGDR
RNS Number : 8438C
Genedrive PLC
22 October 2020
genedrive plc
("genedrive" or the "Company")
Point-of-Care solution to detect SARS-CoV-2 virus in saliva
Development update
genedrive plc (LSE: GDR), the near patient molecular diagnostics
company, announces it has completed the assay design for the
Company's Point-of-Care ("POC") solution for COVID-19 testing and
is now generating very promising analytical data aligned to market
requirements.
The Genedrive(R) SARS-CoV-2 POC Kit is being designed to detect
SARS-CoV-2, the virus causing COVID-19, amplified directly from a
saliva sample without the need to extract viral RNA. This expands
the potential use areas of the product and importantly, allows for
rapid testing to be performed while a patient is present. When
running on the Genedrive(R) POC device the chemistry is detecting a
positive SARS-CoV-2 sample in approximately 15 minutes, with fully
negative samples taking just over 20 minutes to resolve. The limit
of detection is in line with the UK's MHRA Target Product Profile
sensitivity requirements.
The Genedrive SARS-CoV-2 POC Kit follows a similar workflow that
has already been validated in the Company's Genedrive(R) HCV-ID Kit
which received WHO pre-qualification earlier this year.
The Company is targeting the end of the calendar year for
completion of preliminary product evaluations, with full release of
the final CE Marked system in Q1 2021 allowing for thorough
clinical testing requirements. Additionally, the Company is working
to progress to a version 2 of the product, which would accept a
similar freeze-dried PCR bead format previously developed for the
high throughput Genedrive(R) 96 SARS-CoV-2 Kit. This will allow for
lower production costs and highly scalable manufacturing
capacity.
David Budd, Chief Executive Officer of genedrive plc, said:
"Rapid testing for current infection is a cornerstone to any track
and trace programme, to quickly accessing current infection, to
limiting infection, and to giving assurance to people concerned
about their status. We believe the Genedrive(R) POC solution can
contribute significantly to the ongoing management of this global
health crisis."
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 / Oliver Jackson
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 announced
the development of a high throughput SARS-CoV-2 assay and a
Genedrive(R) Point of Care version of the assay, both based on
Genedrive(R) PCR chemistry.
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