US and EU members of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) have recognized the need for a workshop aimed at identifying factors negatively impacting the development, approval, introduction and appropriate use of new diagnostic tools for invasive bacterial infections in both inpatient and outpatient settings. It also addressed the role of diagnostic tools in the development of novel antibacterials and the challenges in the development of companion diagnostics by drug developers.

The intended outcomes of the workshop were the identification of existing barriers and possible solutions in the following areas: 

1. Factors limiting the development and use of contemporary diagnostic tools 
2. Identification of key partners that need to join the effort to advance diagnostics into clinical practice 
3. The role of improved diagnostic tests in enhancing clinical development of novel antimicrobials

The workshop took place on September 28 and 29, 2011, in Brussels.

A summary of the meeting outcomes will be published soon.

The keynote sessions participants were:

• Donald Low, MD - Setting the stage: significance and need for rapid diagnostic tests for invasive bacterial infections
• Rosanna Peeling, PhD - Review of candidate technologies
• John Rex, MD - The importance of rapid diagnostics for advancing antibacterial development

The subjects of the scientific sessions were:

• Session 1: Technical and scientific challenges in the development of rapid diagnostics
• Session 2: Regulatory challenges in the development of new diagnostic tests
• Session 3: Economic factors impacting the development of novel rapid diagnostics
• Session 4: Challenges in the acceptance and adoption of new diagnostic tests

 Agenda

 The importance of rapid diagnostics for advancing antibacterial development, John H. Rex, AstraZeneca Pharmaceuticals

 Regulatory challenges in the Development of Diagnostic Tests, Brad Spring, Director, Regulatory Affairs, BD Diagnostics

 Challenges in the acceptance and adoption of new diagnostic tests: Clinical microbiology laboratory perspective, Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore LIJ Health System Laboratories

 Setting the stage: significance and needs for diagnostic tests, Donald Low, University of Toronto

 Gauging the market for new diagnostic tests for bloodstream and respiratory tract infections, Ellen Jo Baron, Director of Medical Affairs, Cepheid, Professor Emerita, Pathology, Stanford University

 Molecular sepsis diagnostics: Great technology – now what?, Gorm Lisby, Chief Scientific Officer, QuantiBact Inc, Copenhagen, Denmark

 Technical and scientific hurdles in the development of diagnostics for respiratory tract infections, Herman Goossens, Department of Medical Microbiology, Vaccine & Infectious Disease Institute, Universiteit Antwerpen, Belgium

 Challenges and solutions in the development of new diagnostic tests to combat antimicrobial resistance, European Commission, Directorate-General for Research Directorate F – Health, Ruxandra Draghia-Akli, Director

 Evaluating the costeffectiveness of diagnostic tests, Dr Matt Stevenson

 Diagnosis of bloodstream infections: technical and scientific hurdles, Patrick Murray, WW Director, Scientific Affairs, BD Diagnostics

 The future of European Regulation: the proposed changes to the IVD Directive, Dr Rosalind Polley, MHRA

 Review of candidate technologies for rapid diagnostic tests, Rosanna W Peeling, Professor and Chair, Diagnostic Research, London School of Hygiene & Tropical Medicine

 Challenges in the acceptance & adoption of new diagnostic tests for severe infection, Hospital physician perspective, Stephan Harbarth, University of Geneva Hospitals

 The US approach to the regulation of diagnostic tests for bacterial bloodstream and respiratory tract infections, Steven Gitterman, M.D., Ph.D., Division of Microbiology Devices Office of In Vitro Device Evaluation and Safety, CDRH, FDA