This poster address the Non-Small Cell Lung Cancer PD-L1 testing landscape. To view the poster, sign in to DXRX.

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

In this conference poster, Diaceutics explore the 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.

Diaceutics undertook a survey with labs across the EU and UK to gain insights into Liquid Biopsy (LBx) testing. Each lab that participated either have liquid biopsy testing in place or plans to adopt it. The report covers nine countries across the EU including Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden and the UK.

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While adequate reimbursement is considered a prerequisite for adoption of new diagnostic technologies detailed longitudinal investigation of the adoption of new HCPCS codes and the factors influencing it are scarce.

Diaceutics examined the claims for each of the three CPT codes used for next generation sequencing in a large database of claims data from CMS and attempted to correlate presumptive drivers of test adoption.

This study demonstrates that determination of factors affecting adoption of a test technology can be problematic due to a wide variation in claims over a relatively short space of time. However, determination of these factors is important as they ultimately affect patient access to testing and potentially to therapy.

Diaceutics examined the claims for each of the three CPT codes used for next generation sequencing in a large database of claims data from CMS and attempted to correlate presumptive drivers of test adoption

Reports

Non-Small Cell Lung Cancer (NSCLC) PD-L1 Testing Landscape Challenges in the Context of Upcoming In Vitro Diagnostics Regulation (IVDR) Implementation

Read the Liquid Biopsy testing EU report

A Preliminary Review of Adoption of New HCPCS codes for NGS in CMS Claims