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ESP Poster:Non-Small Cell Lung Cancer (NSCLC) PD-L1 testing landscape challenges in the context of upcoming In Vitro Diagnostics Regulation (IVDR) implementation.

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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.

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:

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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" 



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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Implementation of the In Vitro Diagnostic Device Regulation (IVDR) (EU 2017/746), which comes into full effect in May 2022, could potentially disrupt current PD-L1 testing practice for all indications as companion diagnostics will, for the first time in the EU, be regulated.

  • This poster addresses the Non-Small Cell Lung Cancer (NSCLC) PD-L1 testing landscape challenges in the context of upcoming In Vitro Diagnostics Regulation (IVDR) implementation 
  • A Diaceutics real-world data analysis of the potential impact of IVDR enforcement on PD-L1 testing practices in NSCLC

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

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