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First Successful Field Evaluation of HCV Assay
First Successful Field Evaluation of HCV Assay.
About this update from Genedrive Plc
[{"type":"text","content":"\n \nRNS Number : 9367B Genedrive PLC 16 January 2018 \n\nFor release: 16 January 2018\n \ngenedrive plc (\"genedrive\" or the \"Company\")\n \nFirst Successful Field Evaluation of Genedrive® HCV Assay in Africa\n \nPerformance Study in Johannesburg Demonstrated 100% Sensitivity and Specificity\n \ngenedrive plc, (AIM: GDR), the near patient molecular diagnostics company, today announces successful results of the first field study of its Genedrive® Hetaptitis C (HCV) ID Kit in Africa.\n \nThe study, performed in Johannesburg at Lancet Laboratories, one of the leading private pathology testing laboratories operating throughout Africa, was designed to verify genedrive HCV's assay performace across the diverse genotypes which are prevalent in Africa compared to Europe. \n \nIn a cohort of 130 clinical samples from South Africa, Kenya, Ghana, Nigeria, Uganda, and other Sub-Saharan countries, the Genedrive® HCV ID Kit demonstrated sensitivity and specificity of 100% compared to the Abbott M2000 HCV Real time assay as a reference. The cohort was composed mostly of HCV genotypes 1a, 4, and 1b, with the remaining 16% samples from genotypes 2, 3, and 5. The test also demonstrated efficiency of 95.4% (result achieved first attempt).\n \n\"These positive results with the genedrive HCV assay in customer hands on local samples confirms that our good clinical validation performance can be translated into real-world settings where the test will be used, \" said David Budd, Chief Executive Officer of genedrive plc. \"Our test is the first to market as a decentralised qualitative molecular HCV test for use at the point of need. We remain confident it can play an important role in the diagnosis and management of the disease in Africa and in other territories where access to centralized laboratories is limited.\" \n \nDr Allison Glass, Pathologist-in-Charge at Lancet Laboratories Johannesburg, commented, \"Our trained laboratory staff found the Genedrive® HCV system and kit easy to operate, and, compared to the Abbott M2000 platform, required no maintenance, had a small laboratory foot print and faster processing time. Many of the original samples were haemolysed but produced valid results first time, demonstrating the robustness of using PCR direct from plasma. The ge...