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Molecular Diagnostics Europe: Deep Dive Into Regulations, Research

February 28, 2019 | This May 6-9, a rich program on diagnostics will arrive in Lisbon, Portugal. Among the presentations on the Molecular Diagnostics Europe plenary program, Erik Vollebregt (Axon Lawyers, The Netherlands) will dig into the In Vitro Diagnostic Regulation that goes into effect in May 2022, and the General Data Protection Regulation that was implemented in May 2018. Vollebregt will address the forthcoming changes thanks to IVDR, the current impact of GDPR in the field of precision medicine and diagnostic devices, and interplay of the two.

Next Diana Saraceni (Panakes Partners, Italy) will lead a conversation highlighting challenges and opportunities in European diagnostic investments, with help from a panel of experts from the United Kingdom, Germany, France and Spain. The group will explore the difference in Europe markets versus others, for example the US and Israel. They will summarize what has changed in the landscape of European investments over the past few years, and what can be improved? And they’ll share tips for how start-ups can stand out and get attention in the current landscape.

From big picture conversations, the program drills into immunotherapy biomarkers and companion diagnostics, diagnostics at the point-of-care and for infectious diseases and circulating tumor cells. The days are packed full, and we are already starting to mark our agendas. Here are a few of the talks and themes we’ve picked out thus far.

—The Editors


One of the major barriers for understanding human immunological mechanisms is that immune assays have not been reproducibly characterized for a sufficiently large and diverse healthy human cohort. Sanchita Bhattacharya (Bakar Computational Health Sciences Institute, University of California San Francisco, United States) will share the 10,000 Immunomes Project (10KIP), a framework for growing a diverse human immunology reference, from ImmPort, a publicly available resource of subject-level immunology data. Tuesday, 7 May, 9:35

The program as a whole includes several presentations about tumor mutational burden, and we flagged a few in particular. Michael Doherty (Foundation Medicine, United States) will describe a novel, technically robust, blood-based assay to measure TMB in plasma (bTMB), distinct from tissue-based approaches. Using a retrospective analysis of two large randomized trials as test and validation studies, Foundation Medicine found that bTMB reproducibly identifies patients who derive clinically significant improvements in progression-free survival from atezolizumab (an anti-PD-L1) in second-line and higher non-small cell lung cancer. Our data show that high bTMB is a clinically actionable biomarker for atezolizumab in NSCLC, Doherty says. Tuesday, 7 May, 11:15.

As a useful comparison, on Wednesday, Edurne Arriola (Hospital del Mar, Spain) will explore international standardization efforts for tumor mutational burden platforms. Many platforms are being validated to assess TMB in solid tumors, but Arriola worries that without data we can’t assess the consistency of results and clinical validity. Wednesday, 8 May, 17:05

Christopher M. Hartshorn (NIH NCI, United States) will share the perspective of The US National Cancer Institute (NCI) of the National Institutes of Health, and NCI’s most recent and relevant efforts focused at developing markers and tools for patient stratification, deciphering the complex nature of responders vs non-responders, and earlier intervention after dosing. Wednesday, 8 May, 9:05

The Innovative Medicines Initiative is a large-scale public private R&D partnership between the European Commission on the public side and the European Federation of Pharmaceutical Industries and Associations. Pierre Meulien, Executive Director of the Innovative Medicines Initiative, Belgium, will outline how the partnership seeks to accelerate and make more efficient the medicines development process—with a €5 billion budget to facilitate the task. Thursday, 9 May, 9:35

Point-of-care diagnostic tests have not yet made it to the clinical mainstream, Michelle M.A. Kip (University of Twente, The Netherlands), argues. Troponin, for example, is used to rule-out acute coronary syndrome in general practices but is still used far too infrequently. Kip will use this case study to explore test implementation and use in clinical practice and in methods applied to quantify the test’s cost-effectiveness across point-of-care tests. Wednesday, 8 May, 17:35

Stephen C. Francesconi (Defense Threat Reduction Agency (DTRA), United States), on the other hand, distinguishes “point-of-care” from “point-of-need”. DTRA is pursuing FDA-cleared, low cost, highly specific and minimally invasive point-of-need (PON) diagnostic platforms, he says, focusing on developing, optimizing and evaluating two lateral flow immunoassays for the detection of Burkholderia pseudomallei and Yersinia pestis. He will also share DTRA plans to develop a multiplexed, hand-held, single use, rapid PCR-based platform capable of detecting different strains of the Hantavirus. Thursday, 9 May, 16:30

The World Health Organization calls antimicrobial resistance, “an increasingly serious threat to global public health that requires action across all government sectors and society.” Several presentations focus on distinguishing between various infections for better drug stewardship.

Kfir Oved (MeMed, Israel) will present the company’s host-based diagnostic test, MeMed BV, for distinguishing bacterial from viral infections, and MeMed Key, a measurement platform with central lab precision. The new tool provides actionable information to clinicians where and when needed, promoting prudent antibiotic use in the effort to tackle AMR. Tuesday, 7 May, 10:05

The Netherlands have national surveillance systems AMR, specifically for carbapenemase-producing Enterobacteriaceae (CPE) and MRSA, using digital data-exchange for submission and reporting (Type-Ned). All CPEs and infection-related MRSA are analyzed by next-generation sequencing and a genetic relationship between isolates is assessed by whole-genome Multiple Locus Sequence Typing. Recently third-generation sequencing to reconstruct complete plasmids was implemented for CPEs. Leo Schouls (National Institute for Public Health and the Environment (RIVM), The Netherlands) will explain how these data are used to assess trends in national spread and transmission of antimicrobial resistance within healthcare centers. Tuesday, 7 May, 15:50

Adriana Calderaro (University Hospital of Parma, Italy) will share how she is using microbiology lab tests for diagnosing infectious diseases and identifying AMR. MALDI-TOF MS and nucleic acid-based assays were extensively evaluated for diagnostic applications, such as the identification of potential carbapenemase-producing bacterial strains, malaria diagnosis, and a syndromic multiplex PCR system for the diagnosis of gastroenteritis and meningitis. These applications have a significant effect on the best clinical management of infectious diseases. (Calderaro will also later sit on a panel on host and pathogen derived biomarkers). Tuesday, 7 May, 11:15

Koen Deforche (Emweb, Belgium) believes that the falling costs in increasing availability of sequencing will create a revolution in infectious disease diagnostics. Raw sequence data does not provide a simple answer to a diagnostic hypothesis, Deforche says, but it can provide an overview of pathogens in a sample and inform on epidemiological risk factors to guide prevention of infection and surveillance. He will present Genome Detective, a bioinformatics platform he says can unlock this data. Wednesday, 8 May, 10:05

Several presenters will share their experiences using liquid biopsy or circulating tumor cells for oncology applications. G. Mike Makrigiorgos (Dana Farber Cancer Institute and Harvard Medical School, United States) will present novel forms of digital PCR, as well as mutation enrichment-based real time PCR methods that enable several orders of magnitude improvement of detecting mutations or microsatellite instability in cancer than currently possible, are highly multiplex-able, and reduce cost of analysis. Tuesday, 7 May, 15:20

Nicola Valeri (The Royal Marsden Hospital, United Kingdom) will describe the promises and hurdles of liquid biopsies in deciding and monitoring treatment in patients with advanced metastatic colorectal cancer treated with targeted agents. Valeri will also highlight the potential of combining different biomarkers in liquid and tissue biopsies in order to improve patients’ selection and accelerate precision cancer medicine. Wednesday, 8 May, 15:35

In metastatic prostate cancer, Daniel Wetterskog (University College London Cancer Institute, United Kingdom) works with metastatic prostate cancer. Previously his team has shown the association of specific gene aberrations, found in plasma, and the response to currently used therapies in metastatic castration-resistant prostate cancer patients. He will present data from his group’s rapid autopsy project where they have gained understanding how ctDNA reflects the genomic and epigenomic landscape of different metastatic lesions and will describe studies in the early disease setting and the PARADIGM clinical trial (Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic prostate cancer). Wednesday, 8 May, 17:05

Using a single-cell on-chip metabolic cytometry and fluorescent metabolic probes, Qihui Shi (Shanghai Medical College, China) plans to demonstrate metabolic phenotyping on the rare disseminated tumor cells in liquid biopsies of non-small cell lung cancer samples. His results reveal extensive metabolic heterogeneity of tumor cells that differentially engage in glycolysis and mitochondrial oxidation. The cell number ratio of the two metabolic phenotypes is found to be predictive for the patient therapy response, clinical performance and survival. Thursday, 9 May, 11:20

Michael Oellerich (University Medical Center Goettingen, Germany) will describe a particularly promising new approach for the early detection of graft rejection based on the determination of graft-derived circulating cell-free DNA (GcfDNA). Independent studies have shown that GcfDNA detects rejection episodes early, at an actionable stage, and is a more reliable marker of graft injury, compared to conventional tests. GcfDNA may also be useful to guide changes in immunosuppression, to monitor immunosuppression minimization (e.g. during tapering), and to prevent immune activation. Thursday, 9 May, 16:30