Calculus portfolio company, Genedrive plc (LSE:GDR), the molecular diagnostics company, today announces that the Company has achieved CE certification under the EU Medical Devices Directive for its Genedrive® HCV ID Kit, a qualitative molecular assay for Hepatitis C (HCV). CE marking allows for introduction of the assay into Europe as well as low and middle income countries that accept CE certification under their national regulations. In other countries, CE marking can be a necessary prerequisite to begin local registration processes and is an important endorsement for potential distribution partners.
David Budd, CEO of genedrive plc, said: “It is an exciting achievement to be the first company to launch a molecular HCV test designed to be used in smaller hospital laboratories and clinics. CE Marking will allow us to engage with many of the countries where HCV is an endemic healthcare issue. The combination of national screening programs, the availability of cost effective treatment, and consequently a growing demand for molecular diagnostics is an area we can contribute to in a meaningful way. Treatment with pan-genotypic direct acting antivirals can be initiated immediately following a positive HCV result using the Genedrive HCV assay allowing for effective linkage to care, and reducing patient loss during the follow up.”
The Genedrive® HCV assay is performed on the Genedrive® instrument, an innovative and affordable system providing molecular diagnostics at the point of need. The proprietary assay is performed directly from a small, 25ul plasma sample and does not require a separate viral nucleic acid extraction process. The assay provides results within 90 minutes from lyophilised PCR reagents packaged into a single-use, disposable cartridge. Performance evaluation studies to support CE marking of the assay (Institut Pasteur, Paris & Queens Medical Centre, Nottingham) demonstrated sensitivity and specificity fulfilling the requirements published by FIND, the Foundation for Innovation in New Diagnostics.
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