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Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the methodologist that assessed the supportive evidence for the EDL 4 applications.
The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-use and for-research-use-only assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management. - Provides the unique insight of an expert with extensive experience in diagnostics and clinical laboratory on one side and drug discovery and development on the other side - Addresses the challenges of drug development and precision medicine and suggests how to eliminate or mitigate these challenges through better utilization of biomarkers and diagnostics in drug development and patient management - Features case studies and real-life examples from different classes of biomarkers on different platforms for different therapeutic areas and includes more than 200 illustrations
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
This is the first consolidated WHO report on viral hepatitis epidemiology, service coverage and product access, with improved data for action. This report presents the latest estimates on the disease burden and the coverage of essential viral hepatitis services from 187 countries across the world. The report also updates progress made since 2019 in improving access to health products for both hepatitis B and C in low- and middle-income countries, with information from 38 countries that together comprise nearly 80% of global viral hepatitis infections and deaths. The report provides a regional perspective, analysing the barriers and opportunities for countries in each of the 6 WHO regions to expand access to health products for viral hepatitis. It presents actions for countries and stakeholders to accelerate the scaling up of effective viral hepatitis interventions within a public health approach.
The final goal of this publication is to guide on the selection of medical devices. This increases access to medical devices required to prevent, diagnose and treat cardiovascular diseases (including stroke) and diabetes, especially in low and middle resource settings. This publication is intended for Ministries of Health, public health planners, health technology managers, disease managers, researchers, policy-makers, funding and procurement agencies, and support and advocacy groups for patients suffering from cardiac diseases, stroke and diabetes. It serves to inform policy-makers and technical decision-makers on the selection of medical devices required for the package of benefits and interventions for a target population in the context of universal health coverage.
Circulation of monkeypox virus globally has increased demand for diagnostics, prompted rapid development of commercial kits, and driven expansion of networks of laboratories and health facilities offering diagnosis. However, a clear need for more simplified, automated and/or accessible assays remains, including those that can enable testing at decentralized sites outside the laboratory. In response, to increase access to quality-assured, accurate and affordable mpox (monkeypox) diagnosis, an expert consultation process has been initiated, resulting in the drafting of two target product profiles (TPPs): 1. Tests used for diagnosis within health care settings and laboratories (TPP1). 2. Tests used as an aid to diagnosis by detecting orthopoxvirus (OPXV) antigens, which are amenable to decentralized use, including in the community (TPP2). Generally speaking, a TPP is a planning tool for the development of health products. The primary target audience of the TPPs are manufacturers, suppliers, and researchers developing new assays. Additionally, countries and agencies evaluating and/or selecting assays for procurement and use for mpox (monkeypox) testing across both urban and rural environments, especially in settings with constrained resources, may benefit from the criteria and information presented. The TPPs are intended as a strategic reference document for comparison and transparency. The criteria lay out some of the characteristics that are most relevant to inform the expeditious development of tests that address the greatest and most urgent public health need according to WHO. As is the case with all WHO TPPs, it is recognized that access, equity, and affordability are integral parts of the innovation process and need to be considered at all stages, not just after a product is developed.