Doris-Ann interviewed on the IVD industry’s response to the MedTech Strategy
Medtech Insight’s Ashley Yeo interviewed Doris-Ann to better understand the UK diagnostics industry’s reaction to, and expectations of, the Government’s MedTech Strategy.
Membership News
Reports round-up: Clinical Trials and Pro-innovation Regulation of Technologies
Two important reports have been released in the last week covering commercial clinical trials in the UK and pro-innovation regulation of technologies. Read on for a summary of the key recommendations.
IBMS release National POCT Guidance 2023
The IBMS has collaborated with the Royal College of Pathologists (RCPath) and the Association for Clinical Biochemistry and Laboratory Medicine (ACB) to produce ‘Point of Care Testing: National Strategic Guidance for at Point of Need Testing’.
BBC Radio 4 programme on human microbes
In this programme, which may be of interest members, Geoff Watts visits the Human Microbiome Project, sequencing the genomes of bacteria which live on our body to discover how they affect our health.
UKMedLab23 – buy your tickets today!
The Association for Clinical Biochemistry and Laboratory Medicine (ACB) is holding its National Meeting, UKMedLab23, between 12 – 14 June in Leeds, UK – booking information is in the article.
Headlines
MHRA and Genomics England to launch pioneering biobank
The MHRA has announced it will be the first drug safety regulator in the world to pilot its own genetic ‘biobank’, launching 1 June 2023. This will help to better understand how genetic makeup influences the safety of medicines.
New science collaboration to drive innovation across the North West
AMRC Cymru and Science Park have joined forces focus on driving innovation in a bid to boost growth and help companies thrive in North Wales.
Media Monitoring: 27th May – 2nd June
A roundup of all the week’s best IVD-related news!
Member Requests
Point of Care/Near Patient testing opportunity for product portfolio expansion
BIVDA has been asked to identify any members who would be interested in adding a POC analyser for platelet function testing to their product portfolio? If so, please contact Helen who can introduce you to the manufacturer for further discussion and information.
Job posting: Freelance Clinical Trial Coordinator – IVD Medical Devices
Pockit Diagnostics are seeking a highly motivated and experienced freelance Clinical Trial Coordinator to join their team of experts in the field of clinical studies for in vitro diagnostic (IVD) medical devices. The Clinical Trial Coordinator will be responsible for coordinating and managing clinical studies to ensure compliance with applicable regulations and guidelines, as well as company policies and procedures. See the full job description here, and send your application to gonzalo.ladreda@pockitdx.co.uk.
Fast MDx are looking to ally with a PCR assay manufacturer, in order to jointly market their assays working on the Fast MDx test platform.
The potential partner must be a manufacturer of qPCR infectious disease assays, ideally direct from sample, and they must have CE-IVD regulatory approval. They would need to optimise their assays on the Fast MDx platform and produce Instructions for Use (IFU’s) that reference the platform. The fully automated, ultra-fast, low-cost, medium- to high-throughput, Molecular Diagnostic test platform will launch in June.
Platform software is provided by Biosero, a US software company, using their Green Button Go scheduling package and has been designed to smoothly integrate into all LIMS systems. All automation, robotics and pipetting, have been designed by Festo, the leading German automation specialists. And being mobile, it can be used near-patient in a healthcare facility, or just as easily on a farm, testing for disease within livestock. The platform is better explained in this video here and on the website here. Please see the press release here.
Reminder: BSI looking for contributors for safety requirements for electrical equipment for measurement, control and laboratory use standard
BSI have put a call out for those interested and knowledgeable electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision.
If you, or any other members within your organisation may be interested in joining this committee, you can apply to join using this link.
Events Diary
Regulatory Affairs Working Party
Date: Fri, 16 Jun 2023
Time: 10:30 – 13:30 BST
Venue: The Royal College of Nursing