--- title: "Genedrive PLC (GDR.L) CE-IVD certification for Point-of-Care Genedrive®COV19-ID kit" publisher: "Share Talk" author: "sharetalk" published: "2021-12-08T14:19:46+00:00" modified: "2021-12-08T14:19:46+00:00" date: 2021-12-08 canonical: "https://www.share-talk.com/genedrive-plc-gdr-l-ce-ivd-certification-for-point-of-care-genedrivecov19-id-kit/" category: "Healthcare" categories: ["Healthcare", "Pharmaceutical"] tags: ["Antibiotic", "biological", "chemistry", "coronavirus", "COVID-19", "COVID19", "David Budd", "diagnostics", "GDR", "Genedrive", "Genedrive Kit", "Genedrive PLC", "hospital", "infectious diseases", "lab testing", "Manchester", "Matthew Fowler", "molecular", "SARS-COV-2"] image: "https://i0.wp.com/www.share-talk.com/wp-content/uploads/2023/11/Stencil-Google-Chrome-2023-04-19-at-2.47.43-PM.jpeg?fit=1231%2C615&quality=89&ssl=1" format: "news" language: "en-GB" --- # Genedrive PLC (GDR.L) CE-IVD certification for Point-of-Care Genedrive®COV19-ID kit **Published:** December 8, 2021 **Author:** sharetalk **Categories:** Healthcare, Pharmaceutical **Tags:** Antibiotic, biological, chemistry, coronavirus, COVID-19, COVID19, David Budd, diagnostics, GDR, Genedrive, Genedrive Kit, Genedrive PLC, hospital, infectious diseases, lab testing, Manchester, Matthew Fowler, molecular, SARS-COV-2 **Featured image:** ![](https://i0.wp.com/www.share-talk.com/wp-content/uploads/2023/11/Stencil-Google-Chrome-2023-04-19-at-2.47.43-PM.jpeg?fit=1231%2C615&quality=89&ssl=1) --- **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** [http://www.genedrive.com/assays/cov19-id-assay.php.](http://www.genedrive.com/assays/cov19-id-assay.php.) Potential commercial partners or new users interested in the new Genedrive® COV19-ID Kit can contact the Company via info@genedrive.com 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** --- **Original URL:** https://www.share-talk.com/genedrive-plc-gdr-l-ce-ivd-certification-for-point-of-care-genedrivecov19-id-kit/ *Created by [WP Markdown Endpoint](https://wpmarkdownendpoint.com/)*