Genedrive PLC CE-IVD Certification for Human Genotyping Test
17 November 2016 - 8:01AM
RNS Non-Regulatory
TIDMGDR
Genedrive PLC
17 November 2016
RNS
For release: 17 November 2016
genedrive plc ("genedrive" or the "Company")
genedrive plc Announces CE-IVD Certification for Genedrive(R)
Human Genotyping Test
Approval of IL28B Test Further Validates Genedrive(R) Platform
for Rapid Point of Care Human Genotyping
genedrive plc (LSE: GDR), the near patient molecular diagnostics
company, today announces the CE-IVD certification of its rapid
Genedrive(R) IL28B SNP human genotyping test. The test is performed
in 50 minutes from a buccal cheek swab using the Genedrive(R)
hand-held real-time PCR instrument. The CE-IVD certification
further validates Genedrive(R) as a technology platform for
pharmacogenomics.
David Budd, CEO of genedrive plc, said: "We are now looking to
partner with Pharma and Contract Research Organisations to support
the development of SNP assays for clinical trials and clinical
applications. Through our development of the IL28B test, we have
defined a rapid pathway for the generation of a quick, accurate,
and effective human genotyping tests that can be deployed at the
point of need. While the treatment of HCV has evolved since we
started the EU sponsored IL28B programme, the outcome clearly shows
how our innovative technology can be put into practice in
pharmacogenomics applications."
The Genedrive(R) platform and its polymorphism genotyping
capabilities make it an appropriate solution for on the spot
stratification, negating the need for costly and time consuming
patient recall whilst central laboratory tests are processed.
Similarly, the low instrument cost, simplicity of operation, and
connectivity options make it an ideal platform for deployment to
large numbers of coordinated trial sites.
The data supporting the CE-IVD application showed that the
Genedrive(R) human genotyping IL28B SNP test was 100% accurate in
detecting inherited genetic polymorphisms in HCV patients when
compared to the current 'gold-standard' laboratory test (Roche
TaqMan(R) PCR). Genedrive(R) produces results in 50 minutes
compared to the standard approach which uses a blood sample and
which can have a service lab return time of 2 -3 weeks for
results.
The company announced in August that that the Genedrive(R) IL28B
human genotyping test will be used in the STOP-HCV-1 clinical trial
being run by STOP-HCV, a consortium designed to use stratified
medicine to optimise the treatment of patients with Hepatitis C
Virus infection. The trial is designed to assess the effectiveness
of different treatment durations with Direct Acting Antiviral
treatments on HCV Genotype 1 patients
(http://www.stop-hcv.ox.ac.uk/stop-hcv-1-trial).
- Ends -
For further details please contact:
genedrive plc
David Budd: CEO +44 (0)161 989 0245
Peel Hunt LLP
James Steel
+44 (0)207 418 8900
Oliver Jackson
Consilium Strategic Communications
Chris Gardner +44 (0)203 709 5700
Matthew Neal
Laura Thornton
genedrive@consilium-comms.com
Notes to Editors
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 Genedrive(R) platform and MTB/RIF test have been
launched in India and a Genedrive(R) HCV test has been successfully
assessed by the Institut Pasteur, Paris.
genedrive plc was formerly Epistem plc and continues to provide
contract research services to drug development companies under the
Epistem brand name.
Further details can be found at: www.genedriveplc.com and
www.genedrive.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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