Genedrive PLC COVID-19 PCR test approved by Indian regulator (1384X)
April 30 2021 - 1:00AM
UK Regulatory
TIDMGDR
RNS Number : 1384X
Genedrive PLC
30 April 2021
genedrive plc
("genedrive" or the "Company")
Genedrive COVID-19 PCR test approved by Indian regulator
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, announces that the Genedrive(R) 96 SARS-CoV-2 Kit has been
formally approved by the Indian Council of Medical Research
("ICMR"). The Genedrive(R) 96 SARS-CoV-2 Kit achieved 100%
sensitivity and 100% specificity in the performance evaluation
conducted by the ICMR. The Company will now commence commercial
activities in India through its existing distributor Divoc Health
and will also be seeking additional routes to the market.
David Budd, CEO of genedrive plc, said: "We are very happy to
achieve formal registration of our COVID PCR tests in India.
Although the process took longer than anticipated, the performance
data is excellent and will support the commercial process and
customer engagement. Formal product approval is an excellent
testament to our technology."
The Genedrive(R) 96 SARS-CoV-2 Kit is a novel Polymerase Chain
Reaction ("PCR") assay designed to detect active SARS-CoV-2
infection in COVID-19 patients. genedrive's proprietary
"ready-to-go" solid PCR bead format eliminates the need for reagent
preparation or cold temperature storage, making it a preferable
solution for high temperature countries such as India. The format
streamlines laboratory workflow, allowing a patient sample to be
mixed with a single bead and then tested on a variety of
third-party RT-PCR platforms. The test is validated for use on
certain Biorad, ThermoFisher, and Roche PCR platforms.
Given the escalating infection rate in the country, this week
India began to allow the import of certain COVID test kits with
foreign registrations, including CE-Marking, without the need for
ICMR approval. The country has also introduced pricing controls
into the public market, setting a dynamic that does favour the
provision of "basic" tests. The Company believes however that
formal performance evaluation data and ICMR approval will
contribute positively to commercial efforts and premium products
such as gendrive's can play a part in the need for COVID-19
testing.
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 and has in development a
Genedrive(R) Point of Care version of the assay, both based on
Genedrive(R) chemistry.
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