Molecular diagnostics firm Genedrive PLC saw shares skyrocket on Friday after the company announced its 96 SARS-CoV-2 testing kits were certified for commercial sale in the European Union.
Earning certification in line with the EU directive on in-vitro diagnostic medical devices (CE-IVD) allows Genedrive to begin sales in the UK and EU, with the company stating it will send kits to potential customers for initial clinical evaluation.
— genedrive plc (@genedriveplc) May 22, 2020
The kits can detect active COVID-19 infections in patients using a polymerase chain reaction (PCR), significantly reducing testing time and streamlining workflows in laboratories to boost daily testing quotas, a company statement read in late May.
Achieving CE markings will also help back regulatory bodies in other countries such as the Food and Drug Administration in the United States as well as Emergency Assessment and Listing with the World Health Organisation, he added.
"The temperature stable nature of the Genedrive 96 SARS-CoV-2 kit means we have the potential to easily access these global markets, which are in urgent need of testing efficiency and volume," he concluded.
The news comes after Genedrive announced in April a deal with therapeutics manufacturer Cytiva to develop testing kits in five weeks amid concerns the UK government was failing to meet testing quotas across the UK.
— Department of Health and Social Care (@DHSCgovuk) May 19, 2020
Criticisms were launched against Health Secretary Matt Hancock in April after he was unable to verify whether the government could meet its 100,000 test a day quota, UK media found.
UK Government Announces Antibody Testing Programme In Fight Against COVID-19
The news follows announcements from the Department of Health and Social Care, stating that the UK government was launching its antibody testing programme next week to expand testing capacity across the country.
The new programme would boost antibody kits for frontline healthcare workers and help clinicians and scientists "better understand the prevalence of the virus in different regions across the country", a statement read.
A "landmark deal" has supplied 10m kits from industry leaders such as Roche Diagnostics and Abbot Laboratories, and is expected to be rolled out in the next few months, with further deals being negotiated with suppliers.
"Today we have signed contracts to supply over 10 million tests from Roche and Abbott supply in the coming months. From next week, we will begin rolling these out in a phased way. At first, to health and care staff, patients and residents," Health secretary Matt Hancock said in a statement.
The measure was an "important milestone" representing progress in the national testing programme, he added.
— Hampshire Hospitals (@HHFTnhs) May 21, 2020
Prof John Newton, UK national testing programme coordinator, said: "Our understanding of this virus will only continue to grow as new scientific evidence and studies emerge. This new national testing programme is a very important part of that work. COVID-19 is a new disease, and our understanding of the body’s immune response to the virus that causes it is limited."
NHS X, the UK's digital innovation wing for the National Health Services, launched trials of its contact tracing app on the Isle of Wight in early May. The app, which monitors COVID-19 cases across the country, is expected to be launched in late May.
Nearly 89,800 tests were administered on 18 May, with 2.8m tests in total, government figures revealed. But over 35,000 people have died from COVID-19 despite such efforts, the UK Department of Health and Social Care tweeted this week.