Moving Molecular Diagnostics from Bench to Bedside

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9:00 Conference Registration and Morning Coffee 


CANCER: Molecular Biomarkers for Clinical Value

9:30 Chairperson’s Opening Remarks

9:35 Tumor-Derived Circulating DNA as Predictive Biomarker in Oncology

Tim Ward, Ph.D., Staff Scientist, Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, United Kingdom

Recent advances in the molecular characterization of tumor material have highlighted the importance of DNA mutations in the response of cancer patients to modern targeted therapy. It is now possible to determine the mutation status of cancers from isolated circulating tumor DNA. Such a simple blood test heralds the possibility of customized targeted therapy.

10:05 Detecting Molecular Malignancy in Gliomas: Robust Copy Number Analysis of Chromosome 1p and 19q, CDKN2A, PTEN and EGFR (Rearrangements) Using MLPA Analysis

Judith Jeuken, Ph.D., Pathology, Nijmegen University Medical Center, The Netherlands

MLPA analysis investigating glioma biomarkers were previously developed and used to evaluate >350 diffuse gliomas (including 34 primary tumors and their recurrences). A model to establish molecular malignancy was developed which is of additional clinical value next to the histopathological classification as it allows identification of so far unexpected (aggressive) tumor behavior and will thereby ultimately aid in therapeutic decision making.

10:35 Coffee Break

11:00 Probes and Tools for Real Time Optical Imaging of Cancer and Infection

Mark Bradley, Ph.D., Professor, Chemical Biology, University of Edinburgh, United Kingdom

This presentation will discuss cellular labeling for real time optical tracking to sites of infection, smart probes for in vivo monitoring of inflammation and infection, as well as dual modality probes and theranostics in action.

11:30 Molecular Biomarkers for Prostate Cancer

Bastiaan J. de Leeuw, CEO, NovioGendix, The Netherlands

PCA3 has proven to be a valuable new tool in the diagnosis of prostate cancer. How far has PCA3 come to address the clinical need for biomarkers in prostate cancer diagnosis and prognosis? What should we expect from new markers in development? This presentation outlines the development of PCA3 from its discovery to its current implementation and reimbursement.

11:45 Autoantibodies as Biomarkers for Prostate Cancer Risk Assessment in Patients with Elevated PSA and Negative Biopsy
Peter Schulz-Knappe, Ph.D., CSO & Executive Vice President, Diagnostics, Protagen AG
Elevated PSA-levels routinely lead to prostate biopsy for prostate cancer detection and subsequent surgery. As 60-80% of biopsies are negative, better markers are needed in order to avoid unnecessary biopsy. Autoantibodies are frequently formed during cancer disease development as the immune system’s reaction towards altered protein exposure. We have developed an autoantibody-biomarker panel which assists in risk assessment for patients with elevated PSA levels. We present results from our ongoing multicentric studies, including our validation study with assessment of over 700 patients.

Sponsored by

12:00 ExiStation: A Cost Effective, High Throughput qPCR System for Medium and Large Hospitals

Vincent Prezioso, Ph.D., Vice President, Global Marketing, Bioneer Corporation

ExiStation is a semi-automatic and extremely flexible sample purification and Real-Time PCR system which can be run with 12 different samples and CE-IVD certified tests including qualitative and quantitative detection of pathogens with DNA or RNA genomes. The ExiStation can benefit medium to large diagnostics labs with results in 3 hours, the elimination of human error (no manual pipetting), and rapid ROI with increased throughput and profit/test.

Learning objectives:

  • Why the ExiStation is unique
  • How the ExiStation can increase sample throughput
  • How the ExiStation can decrease costs and increase profits
  • Why the ExiStation is the system of choice for large and mid-size diagnostic labs and hospitals

12:15 Sponsored Presentation (Opportunity Available)

12:30 Lunch for Purchase in the Exhibit Hall

13:45 Dedicated Poster Viewing in the Exhibit Hall 


Infectious Disease: Rapid Detection Strategies

14:30 Chairperson’s Remarks

14:35 Regulatory Considerations

Erik Vollebregt, Lawyer, Greenberg Traurig, LLP, The Netherlands

Regulatory and legal requirements for putting diagnostics on the market evolve continuously and become ever more complicated, due to rapidly changing EU legislation and international standards. Companies should start taking regulatory and legal requirements into account already in the design phase in order not to have to make costly and time consuming changes underway.

15:05 A Genomic Fingerprinting Microarray for Identification of Pathogenic Bacteria

Juerg E. Frey, Ph.D., Group Leader, Molecular Diagnostics and Epidemiology, Plant Protection; Federal Department of Economic Affairs, FDEA Agroscope Changins-Wädenswil Research Station, Switzerland

A strategy will be presented to produce genetic fingerprints enabling identification of pathogenic and other bacteria below the species level. Hybridization patterns of test specimen are generated using a generic microarray of short oligonucleotide probes and identification is achieved with high confidence based on a comparison to a reference database. The microarray enables differentiation between bacterial strains, pathovars, and strains with and without a large plasmid. Prospects for further development of this strategy will be discussed.

15:35 Refreshment Break

16:00 Sponsored Presentation (Opportunity Available)

16:30 Towards “Same Day” Blood Culture Pathogen Detection: It’s Here, and It’s Easy

Vanya Gant, M.D., Ph.D., Head of Departments of Microbiology and Infectious Diseases, University College Hospitals, NHS Foundation Trust, United Kingdom

Rapid identification of sepsis causing bacteria drives focused therapy and better outcomes. Several molecular platforms designed to detect and speciate bacteria and fungi from blood cultures exist, but few are widely implemented. Many systems continue to fail because they are either too complicated or not robust enough for everyday laboratory use. The speaker will discuss the reasons for this failed “implementation gap” between a technically “perfect” system and one which will work every day in busy routine diagnostics laboratories. Additional strategic developments for such a robust platform with promising new data will also be discussed.

17:00 Speed is of the Essence - Metagenomic Analysis of Microbes in the Clinic     

Colin Davenport, Ph.D., Clinical Research Group, Hannover University Medical School, Germany

The continually decreasing costs and increasing flexibility of Next Generation Sequencing make future application in the clinic highly likely. Sequencing is highly sensitive and has been found reliable by many independent research groups. However, a number of thresholds remain before adoption is possible. Time to readout is critical, and sample preparation, the sequencing itself and the analysis process are all still problematic. We present methods of speeding up the reliable bioinformatic analysis of millions of sequence reads and reanalyse existing clinical metagenomes. We envisage high throughput sequencing services will become available at the bedside, but not in the near future.

17:45 - 19:00 Interactive Breakout Discussion Groups

Join a facilitated discussion group focused around specific scientific and technology related topics. This unique session allows conference participants to exchange ideas, experiences, and develop future collaborations around a focused topic. Current discussion groups include: 

NGS and Data Quality for Diagnostic Applications

Moderator to be Announced.

Discussion topics include: 

  • Sources of error and methods to address them
  • Run quality
  • Platform specific errors
  • Amplification
  • Alignment errors and artifacts
  • Detection of low abundance variants
  • Contamination


Sequencing Cancer Genomes: Potential Healthcare Applications

Phil Stephens, Ph.D., Senior Scientist, Cancer Genome Project, Sanger Institute, United Kingdom

Discussion topics include:

  • Identification of novel therapeutic targets
  • Characterisation of mechanisms of resistance to targeted therapeutics
  • Surrogate marker of cell kill in early phase clinical trials
  • Monitoring tumor response to therapy in real-time – Reducing toxicity, preventing drug waste
  • Identifying disease relapse before clinically evident (pre-emptive therapy)
  • Choosing intensity of adjuvant therapy based on risk stratification
  • Personal medicine


Circulating Tumor Cells and Cell Free Nucleic Acids: A Real Time Access to the Cancer Genome

Tim Ward, Ph.D., Staff Scientist, Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, United Kingdom

Discussion topics include:

  • Can we use circulating DNA as a surrogate for tumor DNA?
  • Does circulating DNA represent the cancer genome?
  • Will micro RNA be more informative?
  • Can we undertake molecular characterisation of low numbers of circulating cancer cells?


What Does Success Look Like for an Infectious Disease Molecular Diagnostics Test, and Which of the Following Factors Drive This?

Vanya Gant, M.D., Ph.D., Head of Departments of Microbiology and Infectious Diseases, University College Hospitals, NHS Foundation Trust, United Kingdom

Discussion topics include:

  • Ease of use?
  • Robustness?
  • Ease of implementation?
  • Price?
  • Speed?
  • Performance?
  • Gap in existing market?


High-Throughput Protein Detection Technologies in Molecular Diagnostics of Cancer
Cristiana Tanase M.D., Ph.D., Head,  Biochemistry Proteomics, Victor Babes National Institute of Pathology, Romania
Discussion topics include:

  • Multiplex analysis for biomarkers in cancer
  • Early detection of biomarker by serum samples analysis
  • Data Proteomic profiling biomarker discovery by SELDI-ToF-MS, MALDI-ToF-MS, 2DGE and others


NGS: Opportunities for Improving Oral Care Diagnostics: Translating Research to Practice
Bart Keijser, Ph.D., Principal Investigator, Microbial Genomics, TNO, The Netherlands
Discussion topics include:

  • How can the oral care patient benefit from NGS technology?
  • What are the potential hurdles to bring NGS from and R&D setting into routine diagnostics setting?
  • What do we need to translate NGS data and technology to the oral care practice?
  • Could diagnostic NGS data sets be used for data mining?

19:15 – 21:00 CHI Networking Reception

Sponsored by

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