These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.
TUESDAY, 22 MAY
17:00 - 18:00
ADVANCES IN PRENATAL MOLECULAR DIAGNOSTICS
Commercialization Challenges for Fetal Cell-Based NIPT
Moderator: Patrizia Paterlini-Brechot, Ph.D., M.D., Cellular & Molecular Biology, University Paris Descartes, France
- What are the scientific and technical roadblocks to developing a commercial cell-based NIPT?
- What are the competitive requirements and expected benefit?
- What are the insurance and/or regulatory barriers?
- What are the clinical implications for when a cell-based NIPT is commercialized?
The Role of Exomes in Prenatal Diagnostics
Moderator: Ida Vogel, MD, Head of Clinical Genetics, Aarhus University Hospital, Denmark
- When in a pregnancy should we use exome sequencing in prenatal diagnostics?
- Who should take advantage of exome sequencing?
- What are the challenges and barriers to using WES more often? What are the ethical concerns?
ADVANCED DIAGNOSTICS FOR INFECTIOUS DISEASE
Point-of-Care Testing and Issues with the Microbiome
Moderator: Norman Moore, Ph.D., Director of Scientific Affairs, Abbott Rapid Diagnostics
- Factors influencing doctors to prescribe antibiotics with or without diagnostic results
- Factors influencing patients to demand antibiotics
- Overall understanding of the benefits and disadvantages to the microbiome with current antibiotic/antibacterial prescribing habits
Point-of-Need Tests for the Diagnosis of Infectious Disease
Moderator: Ahmed Abd El Wahed, PhD, Head, Virology Laboratory, Microbiology and Animal Hygiene, University of Gottingen, Germany
- Point of need versus point-of-care
- Assay technologies: antibody, antigen detection or nucleic acid-based assays
- The top barriers of developing such assays
CLINICAL APPLICATION OF CELL-FREE DNA
Role of Free Nucleic Acids in Acute Neural Injuries
Moderator: Andrea Regner, MD, PhD, Cellular and Molecular Biology Applied to Health, Lutheran University of Brazil, Canoas, Brazil; Course of Medicine, Lutheran University of Brazil, Canoas, Brazil
- Are free nucleic acids involved in neural injury progression in the traumatic penumbra?
- Are free nucleic acids a promise for neurorestoration?
- From bench-to-bedside: what is the prognostic value of free nucleic acids in critically ill patients?
Quantification of Exosomal MicroRNAs
Moderator: Heidi Schwarzenbach, PhD, Associate Professor, Group Leader, Tumor Biology, University Medical Center Hamburg-Eppendorf, Germany
- Extraction methods of exosomes and microRNAs
- Predominant circulation of microRNAs in exosomes or as cell-free molecules
- microRNA normalization with a reliable reference microRNA
- Discrepancies in up- and downregulation of microRNAs
WEDNESDAY, 23 MAY
18:05 - 19:05
ENABLING TECHNOLOGIES FOR CELL-FREE DNA
Standardisation Challenges in cfDNA Analysis
Moderator: Alison Devonshire, PhD, Science Leader, Molecular and Cell Biology, LGC Ltd., United Kingdom
- What are the best approaches for controlling for cfDNA isolation and quantifying total cfDNA?
- How can QC and reference materials help to compare and standardise results from different liquid biopsy tests?
- What are the challenges of single vs multi-gene-based diagnostics in terms of regulatory approval and clinical translation?
Circulating DNA vs. RNA: Technological Challenges
Moderator: Jo Vandesompele, PhD, Professor, Functional Cancer Genomics and Applied Bioinformatics, Ghent University, Belgium
- What are the challenges associated with analysis of cfDNA vs. RNA?
- What pre-analytical steps need to be taken to ensure proper analysis of particular circulating biomarkers?
- What are the next circulating biomarkers the field will examine, and what challenges do you foresee?
CIRCULATING TUMOUR CELLS
Accelerating the Validation, Approval and Reimbursement of Blood Based Biomarker Assays.
Moderator: Howard I. Scher, MD, D. Wayne Calloway Chair, Urologic Oncology; Co-Chair, Center for Mechanism Based Therapy; Head, Biomarker Development Initiative; Office of the Physician in Chief; Member and Attending Physician, Genitourinary Oncology Service, Medicine Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center, United States
- Patient factors that may affect assay results
- Determining when an assay is "fit for the purpose" of evaluation for a specific context of use
- Clinical utility: a goal of biomarker development rarely demonstrated
- Challenges in the design of dedicated biomarker trials
Overarching Topic: Technical Challenges for CTC-Based Liquid Biopsies
Moderator: Nikolas Hendrik Stoecklein, MD, Professor, Experimental Surgical Oncology, Department of General, Visceral and Pediatric Surgery, University Hospital and Medical Faculty of the Heinrich-Heine University Dusseldorf, Dusseldorf, Germany
- What is a sufficient definition of a CTC for clinical applications?
- What are the minimal requirements for SOPs from companies introducing a new CTC assay before testing it on clinical samples?
- What are the requirements for technical validation of CTC assays before clinical use?
- What is a realistic evidence requirement demonstrating clinical utility for a CTC-based liquid biopsy?
WEDNESDAY, 23 MAY
18:35 - 19:05
Will Molecular Diagnostic Replace Cell-Culture-Based Technologies in The Identification of Bacteria and Their Resistance to Antibiotics?
Moderator: Filipe Arroyo Cardoso, CTO, Magnomics, Portugal
- In which circumstance is molecular diagnostics advantageous over cell culture?
- Which molecular diagnostic technology (micro-array, PCR-based, isothermal amplification, sequencing...) will be a real alternative?
- Is the detection of bacteria DNA informative enough for a correct identification of bacteria and their resistance to antibiotics?
- Is the real advantage of molecular point-of-care platforms is market dependent or will they always be advantageous?
Next Generation Sequencing
Moderator: Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, United States
- Molecular testing for cancer: PCR/FISH vs. Next Generation Sequencing? How large your panel should be: spot testing/multiplex panels, WES, WGS? What will be the impact of the new FDA outsourcing NGS test review to the New York State Department of Health (NYSDH) on the industry in the USA?
- NGS: Should hospitals bring testing in house of outsource to large, experienced reference labs?
- NGS industry: Should manufacturers work on smaller actionable panels and affordable instruments in preparation of the coming DECENTRALIZATION of testing or bet on CENTRAL testing to continue at reference labs and large medical centers (large, high-throughput instruments and panels).