Medilink NOE News Summer 2020 Summer 2020 - Page 4

BRANDON MEDICAL SOURCES VENTILATORS FOR NHS NIGHTINGALE HOSPITAL Brandon Medical, a global medical lighting company supplying hospital and healthcare lighting systems, and our member, has sourced ventilators from the British company, Meditech, for the NHS Nightingale Hospital North West in Manchester. The company also supplied examination lights suitable for tracheotomy to the NHS Louisa Jordan temporary emergency hospital at Glasgow’s SEC Centre. It has offered advice to Leeds Teaching Hospitals NHS Trust and Leeds University on increasing the distribution of oxygen and medical Yourgene a leading international molecular diagnostics group and Medilink member has announced that it has achieved CE-IVD marking for its Clarigene™ SARS-CoV-2 in vitro diagnostic kit, for diagnostic use. The CE-IVD version of the Clarigene™ SARS-CoV-2 test will be used in Yourgene’s high throughput COVID-19 service lab in Manchester and will allow Yourgene to provide corporate partners and healthcare settings, such as care homes and private GP practices, with a fast and reliable COVID-19 lab testing service. The test is a RT-qPCR (real-time quantitative polymerase chain reaction) assay which detects the presence of SARS CoV-2 viral RNA. The assay uses two viral RNA targets, nucleocapsid gene (‘N’) andenvelope gene (‘E’), which are SARS-CoV-2 specific and this prevents any cross reactivity with other Coronaviruses. The use of dual viral targets and assay controls provides a more reliable result, whilst also making it more desirable across several European regions which require the dual viral targets for reimbursement. air, and is manufacturing parts for the UK ventilator programme – including for the new Mercedes-UCL CPAP ventilator and existing British-made machines. Brandon Medical has a large stock of medical gas terminal units and hose assemblies which may assist in the provision of larger scale distribution. These include medical lights for intubating patients and tracheotomy, some medical gas parts for oxygen and medical air pipelines, ICU pendants, medical point of care computers, medical IT systems (special electrical isolated power supplies for ICU and theatres- formerly known as IPS), as well as operating theatre items and components. At the beginning of the pandemic, the company increased its production to meet the demand from the NHS and help in the fight against the virus. For more than 70 years, Brandon Medical has provided healthcare professionals with reliable, highquality and affordable medical equipment packages for operating theatres and critical care. CE-IVD MARK FOR CLARIGENE™ SARS-COV-2 TEST FOR YOURGENE HEALTH PLC Clinical validation of the test has shown >99.9% accuracy with no false positive or false negative results. Additional studies have shown 100% repeatability data and an average >99.7% reproducibility. The Clarigene test only detects SARS CoV-2 RNA and shows no cross reactivity with other respiratory viruses. Inadequate sample collection has been a significant issue in the global pandemic and the Clarigene test kit has an internal control that detects poor-quality samples to give an invalid result, allowing greater confidence in negative results. Lyn Rees, CEO of Yourgene, commented: “I would like to congratulate the Yourgene team for their hard work in achieving the CE-IVD mark for the Clarigene™ SARS-CoV-2 Test in such a short amount of time. There is a significant opportunity to drive sales of the Clarigene™ SARS-CoV-2 kits, however we understand that the COVID-19 testing market is dynamic and with this in mind, we will commit to updating shareholders on a quarterly basis on the commercial take-up of this product.” UK COVID-19 RAPID ANTIBODY TESTS APPROVED FOR PROFESSIONAL USE The COVID-19 rapid antibody test, developed by Medilink member Abingdon Health, the medical device manufacturer leading the UK-Rapid Test Consortium (UK-RTC), has received its CE mark. This means it is approved for professional use in the UK and EU. This milestone means the rapid test, for detection of IgG antibodies to the SARS-CoV-2 virus (COVID-19) is now available for distribution for professional use. It will be mass produced and tests will be rolled out from the end of August. The test can be administered by healthcare professionals, such as doctors, nurses, pharmacists and healthcare workers. Following production of tens of thousands of tests across multiple production scale batches the test has been shown to be 99.40% accurate. Testing was performed at the Ulster University and at the laboratories of Abingdon Health. The test will be named the “AbC-19TM Rapid Test”. It uses a small drop of blood from a finger-prick, and shows results in 20 minutes, without the need to send a sample to a lab. The test can help build a swift and clear picture of how the virus has spread throughout mass populations. It can also help establish the effectiveness of any vaccine which provides protection by creating new antibodies. This information will be critical to managing current and future outbreaks of COVID-19. To develop and mass produce the volumes needed for the UK population, Abingdon Health set up and led the UK-RTC in April this year. The consortium brings together the UK’s largest rapid test medical manufacturers, working together to provide capacity for delivery of more than a million tests per month. The company has fast-tracked development and completed CE marking in just 14 weeks. This process would normally take 10 months or more. In total, the UK-RTC can manufacture 10m tests within a six-month period. Abingdon Health has acquired all the materials needed for all the members of the consortium to manufacture the test for this initial 10m tests and the consortium is now ready to produce this high quality test at scale. Abingdon Health CEO Chris Yates said: “This UK designed, developed and manufactured highquality rapid diagnostic test is a breakthrough for UK life sciences and a triumph of British business. WORLD LEADING ORTHOPAEDIC MANUFACTURER TO OPEN NEW FACILITY Orthoplastics, a Medilink member and a world leader in the development and supply of implantable-grade plastics, has announced a significant investment in a new facility in the North West. The company, which was founded in 2005, is a pioneer within the orthopaedic sector and focuses on providing end-to-end solutions for medical device OEMs. The investment, which comes in the form of another largescale manufacturing facility, is a huge vote of confidence in the Northern Powerhouse region, which has a flourishing life sciences manufacturing sector. It further increases the company’s market capabilities and will create around 100 new jobs at the Futures Business Park Development, which is in the heart of the Rossendale Valley and in the constituency of the former Minister for the Northern Powerhouse, Jake Berry MP. The Government’s Industrial Strategy puts innovation at its heart, and wants to encourage the discovery, innovation and commercialisation of cutting-edge ideas. Orthoplastics is a typical example of this kind of company and has been developing technological solutions for the manufactur of high-performance, implantable medical devices for 15 years. Mark Allen, Managing Director, Orthoplastics said, “Innovation is at the heart of the future of UK manufacturing, and this factory will provide our customers with the confidence in our long-term investments strategy, whilst demonstrating our strategic partnership and commitment.” The new facility is due to open in early 2021 and will attract an annual investment of £5 million from the company. This long-term UK manufacturing investment demonstrates the confidence the company has both in its domestic and international markets, even at this uncertain time. The news comes as the Prime Minister announces a boost for UK science, with top scientists given fast-tracked entry to the UK – a major boost for the sector. “This significant investment underlines our belief that there is huge potential for innovation and growth within the Orthopaedic sector. It is also the next step towards achieving our ambition of pioneering improved patient outcomes and the longevity of implantable medical devices. Joint replacement procedures such as HIP and knee surgeries are highly successful of course, but we are leading the way in the evolution of new concepts to improve these life changing operations”, Mr Allen said. 6 7