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ESMO Poster: Assessment of EU4 laboratory readiness for FGFR2 fusion testing of cholangiocarcinoma by NGS
IVDR Impact Analysis Report :
Impact analysis of the IVDR on diagnostic practices & patient care across the EU: Lessons from the COVID-19 pandemic
The upcoming In Vitro Diagnostics Regulation (IVDR - EU 2017/746) is currently in the process of replacing the In Vitro Diagnostics Directive (IVDD - 98/79/EC) of the European Union (EU). In this report, a specially-convened group of European laboratory stakeholders and patient advocates considers the significant implications of this change on the regulations specifically governing the development and validation of diagnostic tests in the EU.
The team of experts collaborating on this report came together in a working group (the European IVDR Working Group) in Amsterdam on the 29th of January 2020.
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The Report
In the Report you’ll gain insights into the potential adverse impacts that the IVDR as currently constructed will have on diagnostic practices and subsequent patient care across the EU (as illustrated by the COVID-19 pandemic), due to the threat of significant shortage of diagnostics that comply with the regulation.
A number of recommendations provided by the European IVDR Working group to:
Increase awareness within labs of the implications of IVDR to their test practices
Encourage individual labs to audit their test practices
Raise awareness with other stakeholders (patient advocacy groups, the pharmaceutical industry) and
Develop a network of labs/organisations to provide a unified voice for the labs to express their concerns to regulators
Report insights:
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New ISPOR 2021 Abstract :
"The Potential Healthcare and Economic Impact of The Implementation of the In Vitro Diagnostic Regulation on Non-Small-Cell Lung Cancer Patients in the European Union"
Highlights
Understand the potential impact of IVDR on patients with metastatic NSCLC in the EU.
The annual cost of treating the patient NSCLC cohort were determined and then the fraction of LDTs employed to calculate the number of patients and costs to pharma that were under threat of having therapy withheld.
Scenarios at 10% to 100% LDT failure were analysed resulting in 4,255 to 42,546 NSCLC patients potentially losing therapy at a cost to pharma revenue of €335M to €3.3B.
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Title: PS-22-005; Non-Small Cell Lung Cancer (NSCLC) PD-L1 testing landscape challenges in the context of upcoming In Vitro Diagnostics Regulation (IVDR) implementation. Guided Walkthrough Video
Authors: Gwendolyn Courtois MSc2, Lauren Parnham2, Katherine E. Keating PhD2, Peter Riccelli PhD1, Dave Smart PhD2, Susanne Munksted MSc2, Jordan Clark MPhil2, Keith Kerr MD, FRCPath3
Impact analysis of the IVDR on diagnostic practices & patient care across the EU: Lessons from the COVID-19 pandemic. Guided Walkthrough Video.
Guided Walkthrough Video
Authors: Gwendolyn Courtois MSc2, Lauren Parnham2, Katherine E. Keating PhD2, Peter Riccelli PhD1, Dave Smart PhD2, Susanne Munksted MSc2, Jordan Clark MPhil2, Keith Kerr MD, FRCPath3
Authors:Marianna Sciortino PhD1, Neil Atkey Dip RCPath1, Brigitte Bisaro PhD1, Gwendolyn Courtois MSc1, Nikola Holtkamp PhD1, Jone Iparraguirre PhD1, Bob Holt PhD1, Peter V Riccelli PhD2, Susanne Munksted MSc1, Jordan Clark MPhil1
Introduction
ESMO recently published Next Generation Sequencing (NGS) testing recommendations for solid tumors, which includes cholangiocarcinoma (CCA), for use of small or large multigene target NGS panels to identify actionable variants. The European Medicines Agency has approved an FGFR2 inhibitor for advanced, metastatic CCA FGFR2 fusion positive patients. With more FGFR2 therapies anticipated, it will be important to identify all CCA patients with any FGFR2 fusion.
Key Conclusions:
- The proportion of labs ready to provide full FGFR2 fusion detection via NGS in CCA varies across the EU4. This may reflect a possible centralized approach to NGS testing in some countries.
- There may be a need for more labs to prepare NGS use beyond common diseases (e.g., lung cancer) to rarer conditions like CCA.
- NGS provides a means to identify any fusion present using a single test and is the recommended method of choice to provide simultaneous, full coverage of FGFR2 fusions where the paucity of tissue for tumors (e.g., CCA) limits PCR or FISH.