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ASCO Poster: Significant decline in cancer diagnostic testing in US CMS population during the COVID-19 pandemic

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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.

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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:

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Raymond Henderson, Declan French, Elaine Stewart, Adam Idica, Dave Smart, Markus Eckstein, Jordan Clark, Mark Lawler 

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

Authors

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Key Conclusions of the Study:

- Based on the data presented in this study there was a significant decline in patients presenting to their primary care physicians with suspicion of cancer for diagnostic investigation linked to COVID-19 prevention strategies.

- It is therefore predicted that these patients may subsequently present with a more advanced cancer. Potential excess morbidity, mortality and cost associated with absent or delayed diagnosis should be factored into cancer control programs going forward.

Authors: Dave Smart, Peter Riccelli, Keith Kerr, Jordan Clark, Susanne Munksted , Mark Lawler/em> 

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Key Conclusions of the Study:

- Previous estimates of the R&D cost of a medicine were between US$314M and US$2.8B. However, the use of biomarkers in the R&D of an oncology medicine increase the possibility of FDA approval, consequently decreasing costs.

- Analysing data from the SEC and clinicaltrials.gov R&D costs of a precision cancer medicine (PCM) versus a one-size-fits-all (OSFA) oncology drug were modelled.


Authors: Raymond Henderson, Declan French, Elaine Stewart, Adam Idica, Dave Smart, Markus Eckstein, Jordan Clark, Mark Lawler

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ASCO Abstract: Does the precision oncology medicine development pathway deliver value for health systems?

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