Genedrive PLC (GDR.L) CE-IVD certification for Point-of-Care Genedrive®COV19-ID kit

genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that further to the announcement of 29 November 2021, its rapid point of care Genedrive®COV19-ID Kit has received CE-IVD certification under the European Communities Council Directive 98/79.

The Genedrive® 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 viral extraction. 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. In the case of the new Omicron variant of concern, there were approximately 650 Omicron (B.1.1.529) genome sequences identified within the global reference database as of 7 December 2021, and the Genedrive®COV19-ID Kit was 100% inclusive in detection.

Sensitivity and specificity of the Genedrive®COV19-ID Kit was 98.2% and 98.9% respectively in its clinical validation cohort of 149 samples (58 positives at greater than 500 copies per ml) which were referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. The Genedrive® COV19-ID molecular test offers several orders of magnitude improvement in sensitivity compared to antigen lateral flow devices. The clinical cohort included five confirmed SARS-COV2 Delta variants, which were all detected by the Genedrive® COV19-ID test. The sensitivity and specificity of the assay on the entire cohort met the current requirements of the UK’s MHRA Target Product Profile for a SARS-CoV-2 Point of Care molecular diagnostic test.

Information about the new Genedrive®COV19-ID Kit can be found at Potential commercial partners or new users interested in the new Genedrive® COV19-ID Kit can contact the Company via [email protected]

As detailed in the announcement on 29 November, the product is being provided for review and evaluation to a range of potential commercial partners who have actively expressed interest in the product with regards to European opportunities.

David Budd, CEO of genedrive plc, said:  ”This is an important milestone in the development of our new rapid molecular COVID19-ID test and we can now move forward with our commercial plans. We have developed a very fast and easy to use Point of Care system that will allow immediacy and convenience in molecular testing, rather than waiting many hours or days for results from a central laboratory. The newest Variant of Concern highlights that COVID is an ongoing and long-term global health issue and our ability to manage it better can be aided by rapid detection to prevent ongoing transmissions, using innovative products like the new Genedrive COV19-ID kit.”

For further details please contact:

genedrive plc

+44 (0)161 989 0245

David Budd: CEO / Matthew Fowler: CFO

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