Genetic testing meaning

In this issue: Post-market Commercialisation Competition in life sciences Medical devices Data protection in life sciences Pharmaceuticals—regulatory framework Intellectual property LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Post-market Industry coalition urges withdrawal of AI Liability Directive MedTech Europe, with 11 other industry bodies, issued a joint statement urging withdrawal of the proposed AI Liability Directive (AILD). They say it would add needless legal complexity, undermine EU competitiveness and deter artificial intelligence (AI) innovation. The group insists the newly adopted Product Liability Directive should be implemented and reviewed before any further liability regimes are considered. They also warn the AILD could unsettle established contractual liability practices and conflicts with the EU’s Sustainable Prosperity Deal and the Draghi Report’s call for a streamlined AI legal framework. See: LNB News 05/02/2025 58. Commission proposes Critical Medicines Act to bolster supply chain The...

Clarke v Matthew Poole and others [2025] EWCA Civ 447 What are the practical implications of this case? The case engages CPR 52.30 (reopening of final appeals) and highlights the central role of personal autonomy when considering objections to testing. It remains a realistic prospect that the claimant’s appeal may ultimately fail, and there could be a restatement of the Laycock test. Safeguarding the personal autonomy of those turning to the courts for justice is fundamental to judges’ decision-making, as is maintaining clarity in the principles they apply... What was the background? The claimant’s mother and maternal grandfather were carriers of the DM gene yet were asymptomatic. Before the accident, when given the choice, the claimant declined EMG testing. She did not wish to find out whether she had DM, to bear the anxiety that knowledge might bring, or indeed to have...

The EU legacy and Brexit autonomy For decades, the UK operated within the EU’s rigorous and comprehensive food safety framework. Following Brexit, however, the country secured the freedom to design its own food safety rules, particularly around innovation and emerging technologies. Stepping away from the EU’s regulatory machinery has created space for faster, more agile progress. Challenges in the route to market Despite swift advances in science and food development, routes to market have been slowed by regulation. Industry has viewed these procedures as complex, lengthy, and obstructive to innovation, with companies often calling approval pathways opaque, resource-intensive, and hard to navigate. With its renewed independence, the UK plans to quicken growth at pace, from cultivated meat through to insect protein. As part of the government’s Vision for Engineering Biology, last year brought the Genetic Technology Act, intended to stimulate scientific innovation via a streamlined, proportionate regulatory framework. The meeting point between the new act and existing rules designed to enable innovation has prompted the UK’s Food...

This Practice Note outlines commonly referenced medical tests found in patient medical records for personal injury and clinical negligence cases, including fluid tests, imaging, internal investigations, electrocardiogram (ECG), electroencephalography (EEG), biopsy, angiogram and genetic testing. A. Fluid tests Blood tests Full blood count—assesses haemoglobin, white cell and platelet levels. Low haemoglobin may suggest anaemia (potential internal bleeding). High haemoglobin may indicate underlying lung disease. Reduced white cell counts may point to bone marrow issues, cancer or a viral infection. A raised white cell count may imply infection or leukaemia. Low platelet levels may reflect a viral infection or an autoimmune condition. Erythrocyte sedimentation rate (ESR)—may signify inflammation, such as arthritis, or other diseases, such as Crohn’s Disease. C-reactive protein (CRP)—produced by the liver; an elevated CRP indicates inflammation. Coagulation test—measures how quickly blood clots; this may indicate bleeding disorders, such as haemophilia. Blood gases test—measures levels of oxygen and carbon dioxide in the blood. An imbalance can be a marker of...

What is personalised medicine Personalised medicine has been part of clinical practice for quite some time. Clinicians have, to differing degrees, tailored care to individual patients using information gathered about them. Over the last decade and a half, however, the emergence of systems biology has markedly broadened its scope; in contemporary practice it depends on collecting as much data as possible about a specific biological system under study. The aim is to interpret these collected datasets in ways that enhance understanding of a living system and its pathologies, ultimately enabling targeted interventions that are responsive to an individual patient or to groups of patients. It is often characterised as care that is ‘custom‑made’, set against the more traditional, ‘one size fits all’ model. Although many cell therapies, gene therapies and other advanced therapy medicinal products (ATMPs) are regarded as personalised medicines, the domain is wider and encompasses every step of the medical process, from start to finish, beginning with diagnosis—frequently molecular diagnosis using biomarkers—and concluding with targeted medicinal treatments...

Practice Note This Practice Note outlines the core principles for applying for a declaration of parentage under the Family Law Act 1986. It addresses the court’s jurisdiction and the need for an applicant to show a sufficient personal interest. It also examines who the parties are, declarations relating to adopted children, and declarations of parentage for the purposes of the Child Support Act 1991 and the Child Support Act 1995. Declarations of legitimacy are likewise considered... In Re G (children) (residence: same-sex partner), Baroness Hale identified three routes by which a person may become a parent, namely: genetic parenthood — the supplying of gametes that create the child gestational parenthood — the conceiving and carrying of the child social and psychological parenthood — the relationship formed as the child seeks care and the parent meets the child’s needs The court cannot issue a declaration of psychological parentage, as such declarations are confined to matters of fact. See Practice Note: Acquisition...