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Diaceutics releases data highlighting how the implementation of In Vitro Diagnostics Regulation may affect the PD-L1 testing landscape in Non-Small Cell Lung Cancer

6 October, 2021

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Diaceutics releases data highlighting how the implementation of In Vitro Diagnostics Regulation (IVDR) may affect the PD-L1 testing landscape in Non-Small Cell Lung Cancer (NSCLC) at European Congress of Pathology (ECP) 

  • Implementation of the In Vitro Diagnostic 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 be regulated for the first time in the EU.  
  • The new IVDR will require labs to use only approved CE IVD tests or justify their use of Laboratory Developed Test (LDT), to ensure PD-L1 testing is accessible for patients. 
  • The analysis of our data reveals significant use of LDTs for PD-L1 testing within some markets, although testing practice varies extensively across Europe. 
  • The IVDR implementation may impact up to 62% of PD-L1 testing labs across the EU4 and potentially restrict treatment options in NSCLC patient management 

Diaceutics PLC, the diagnostic commercialization company, reveals the data from an abstract poster discussion presentation, at 33rd European Congress of Pathology (ECP) which took place as an online congress from 29 - 31 August 2021 highlighting Non-Small Cell Lung Cancer (NSCLC) PD-L1 testing landscape challenges in the context of upcoming In Vitro Diagnostics Regulation (IVDR) implementation.  

The ECP 2021 Congress is the center for European international diagnostic and academic pathology. Pathologists and their collaborators, molecular biologists, geneticists, bioinformaticians, and information technologists meet to share recent and important advances that offer the latest diagnostic, prognostic and predictive information needed in the best patient care.  

Diaceutics presented data and findings from a study into how the implementation of In Vitro Diagnostics Regulation (IVDR) may affect the PD-L1 testing landscape in Non-Small Cell Lung Cancer (NSCLC). To date, harmonization studies have enabled labs to develop and use LDTs that provide equivalent results to CDx kits. However, from May 2022, labs using LDTs will need to comply with accreditation and LDT/commercial kit equivalence requirements dictated by IVDR regulations.  

The approval of multiple PD-L1 CDx tests that require different IHC platforms and link to different therapies has made the implementation of PD-L1 testing for NSCLC patients challenging. IVDR adherence will be challenging for many labs across Europe as they will be required to justify their use of LDT or transition to multiple CE IVD kits and/or platforms.   

The analysis of Diaceutics data reveals significant use of LDT for PD-L1 testing within some markets, although testing practice varies extensively across Europe. Labs using commercial kits only dominate the testing landscape in the UK (100%) and Spain (87%), whereas labs using only LDTs (standalone antibodies or kits used off-label) are more common in France (96%), Germany (88%) and Italy (66%).  

The significant use of LDTs for PD-L1 testing may potentially impact up to 62% of PD-L1 testing labs across the EU4. Therefore, there is an urgent need for clarification of the criteria that constitute LDT justification, as well as guidance for labs on how to generate and provide the evidence required to meet the criteria ahead of IVDR enforcement. The inability of labs to comply with IVDR may reduce access to PD-L1 testing and potentially restrict treatment options in NSCLC patient management. 

Katherine (Karen) Keating, Deputy Lead, Knowledge & Implementation Team at Diaceutics and one of the poster authors noted that: "IDVR seeks to improve the quality of IVD testing, however, its implementation has the potential to adversely impact testing in a number of areas. In the context of standardizing the current varied PD-L1 testing landscape, it will take time for Notified Bodies to review lab submissions around justifications for current LDT testing strategies, and/or for labs to migrate to CDx testing.  

Consequently, we anticipate that there may be challenges with access to suitable PD-L1 testing during this period of transition, particularly in France and Germany where there is a significant preference for LDT testing, potentially resulting in delays to test results that will impact timely treatment decisionsThe data that is presented at this year’s ECP continues to highlight the potential of Diaceutics to enable better testing and ultimately better treatment for patients with cancer."

The presentation of Diaceutics’ analysis of NSCLC PD-L1 testing landscape challenges in relation to the upcoming IVDR regulations at ECP 2021 Congress supports the Company’s campaigning alongside the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Cancer Patient Coalition (ECPC) to call for a postponed application and phased implementation of the In Vitro Diagnostic Regulation.  (Letter from EFPIA ECPC and Diaceutics calls for postponed application and phased implementation of the in vitro diagnostic Regulation - Diaceutics) 

Diaceutics provides the world’s leading pharmaceutical companies with an end-to-end solution for the launch of Precision Medicine diagnostics enabled by DXRX – The Diagnostic Network®.   

DXRX is the world’s first diagnostic commercialization platform for Precision Medicine, integrating multiple pipelines of real-world diagnostic testing data from a global network of laboratories. Through the application of machine learning and standardization of our proprietary data, Diaceutics can identify the best possible testing journey or “Deductive Diagnostic Pathway (DDP®)” for patients at disease level, providing the industry with a guide to getting the right medicines to the right patients, faster. 

Details of the presentation are as follows: 

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

Authors: Gwendolyn Courtois MSc 2, Lauren Parnham 2, Katherine E. Keating PhD 2, Peter Riccelli PhD 1, Dave Smart PhD 2, Susanne Munksted MSc 2, Jordan Clark MPhil 2, Keith Kerr MD, FRCPath 3 

1: Diaceutics Inc., Parsippany Troy Hills, NJ   

2: Diaceutics plc, Belfast, United Kingdom  

3: Department of Pathology, Aberdeen University Medical School & Aberdeen Royal Infirmary 

 To access the study, click here:  In Vitro Diagnostics Regulation (IVDR) Report | European IVDR Working Group (diaceutics.com) 

Information about The ECP 2021 Congress can be accessed here: 33rd European Congress of Pathology - 33rd European Congress of Pathology (esp-congress.org) 

About Diaceutics

At Diaceutics we believe that every patient should get the precision medicine they deserve. We are a data analytics and end-to-end services provider enabled by DXRX - the world’s first Network solution for the development and commercialization of precision medicine diagnostics. 

Diaceutics has worked on every precision medicine brought to market and provides services to 36 of the world’s leading pharmaceutical companies. We have built the world’s largest repository of diagnostic testing data with a growing network of 2500 labs in 51 countries.

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