Genedrive PLC Point-of-Care COV19-ID Kit receives CTDA approval (1582N)
May 30 2022 - 2:01AM
UK Regulatory
TIDMGDR
RNS Number : 1582N
Genedrive PLC
30 May 2022
genedrive plc
("genedrive" or the "Company")
Point-of-Care Genedrive(R) COV19-ID Kit receives Coronavirus
Test Device Approval ("CTDA")
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, announces that the UK Medicines and Healthcare Products
Regulatory Agency has granted a CTDA enabling the sale of the
Genedrive(R) COV19-ID Kit in the United Kingdom. Genedrive's
application for approval, under the requirements that came into
force on 28 July 2021 via The Medical Devices (Coronavirus Test
Device Approvals Regulations (2021)), was made on 21 December
2021.
Since submission for approval, the product has undergone
positive external validation, commercial partners have been engaged
in specific countries, and product claims have been expanded to
include the testing of asymptomatic patients.
Information about the Genedrive(R) COV19-ID Kit can be found at
https://www.genedrive.com/assays/cov19-id-assay.php
David Budd, CEO of genedrive plc, said: "We are very pleased to
have received a CTDA, which now allows the UK access to the fastest
point-of-care COVID molecular test. The performance of the test has
met CTDA standards in all regards, which positions genedrive well
to engage in opportunities as they develop going forwards in the
UK."
The Genedrive(R) COV19-ID Kit is a rapid molecular diagnostic
test that delivers positive results as quickly as 7.5 minutes and
negative results at 17 minutes. It utilises Reverse-Transcription
Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary
buffer formulation to achieve rapid results without requirement for
user viral extraction steps. Performed directly from a
mid-turbinate nasal swab, the assay targets the ORF1ab and N genes
of the SARS-CoV-2 genome, adding robustness against emerging
SARS-CoV-2 variants.
For further details please contact:
genedrive plc +44 (0)161 989 0245
David Budd: CEO / Russ Shaw: CFO
Peel Hunt LLP (Nominated Adviser
and Joint Broker) +44 (0)20 7418 8900
James Steel
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, MT-RNR1 for Ototoxicity, certain military biological targets,
and a high throughput SARS-CoV-2 assay.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCBKFBQBBKDAPB
(END) Dow Jones Newswires
May 30, 2022 02:01 ET (06:01 GMT)
Genedrive (LSE:GDR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Genedrive (LSE:GDR)
Historical Stock Chart
From Apr 2023 to Apr 2024
