LONDON: genedrive plc (LON:GDR), the near patient molecular diagnostics company, has completed the last significant manufacturing milestone in the co-development of the Genedrive 96 SARS-CoV-2 kit with Cytiva.
The PCR-based test has completed its pilot manufacturing runs and yielded high performing multiplexed assays for COVID-19 testing. The overall project plan currently remains on track and the company is targeting CE marking in approximately 3 weeks’ time.
The Genedrive 96 SARS-CoV-2 test is one of two assay programmes the Company is developing following an announcement made on 25 March 2020, with a genedrive point-of-care assay due later in the calendar year.
The Genedrive 96 SARS-CoV-2 assay combines genedrive’s PCR chemistry integrated with Cytiva’s LyoStable stabilisation technology. The combination delivers several key competitive advantages to the genedrive test compared to the liquid, kit-based assays already on market.
The Genedrive 96 SARS-CoV2-test is a final format test which only requires the addition of patient sample, with no other user preparation required. Integrated controls within each test give confidence to the user that the input sample is of good quality, and the integrity of each reaction mix is confirmed with another internal standard.
The temperature-stable nature of lyophilisation technology means that the test can be transported globally without the need for refrigeration, which will support global product distribution.
David Budd, Chief Executive Officer of genedrive plc (LON:GDR), says: “We are very pleased to have passed these technical milestones and with CE marking planned we will offer our novel high throughput test in the near future. Users will be able to adopt a COVID-19 testing solution with unique assay features. The team here at genedrive has been working in close cooperation with the Cytiva team – and both have excelled in the development of a complex assay, while maintaining a firm focus on quality and performance; we remain confident that this assay will make a significant contribution to the testing market.”
Genedrive PLC is listed on London Stock Exchange under the symbol LON GDR. It is a molecular diagnostics company that specializes in the development and commercialization of a point-of-care molecular platform for the diagnosis of infectious diseases, genotyping, pathogen detection, and other applications. They are known for their Genedrive® HCV-ID test, which has received CE-IVD Certification and is available in Africa and the Asia Pacific region.
The company has been actively expanding its product range, including the Genedrive® MT-RNR1 ID Kit, which is the world’s first point-of-care genetic test aimed at reducing the risk of aminoglycoside-induced hearing loss. This test has seen initial orders from multiple countries and is being adopted by NHS hospitals for routine use.
Additionally, Genedrive has achieved UKCA marking for their new Genedrive® CYP2C19 test, which aids in the treatment management of stroke patients and is preparing for NHS introduction³. The company’s mission is to create easy-to-use, point-of-care pharmacogenetic tests that can be used in time-critical settings to directly improve clinical outcomes².