Webinars
- IQN PATH WEBINAR STANDARDIZATION IN TMB ASSESSMENT: HOW FAR WE ARE
Webinar held live on 16 June 2021 and the recorded version is available here.
- ESP-IQN PATH WEBINAR ON BIOMARKER TESTING
Webinar held live on 20 October 2021 and the recorded version is available here.
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ESP-IQN PATH WEBINAR ON PD-L1 TESTING
Webinar held live on 3 November 2021 and the recorded version is available here.
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IQN Path – ECPC – EFPIA –– QARAD WEBINAR
IVDR: IMPACT AND OPPORTUNITIES FOR A MOLECULAR PATHOLOGY LABORATORY
Webinar held live on 25 November 2021 and the recorded version is available here.
2025 Meeting will be held as a hybrid event on 9-10 May
A 2-day meeting on EQA in molecular pathology gathers the association’s academic and corporate members, project managers and the major stakeholders in the field. The programme offers an update on the projects and the future developments. Furthermore, the Board meeting and the General Meeting are held in this context.
The 2025 Meeting is on 9-10 May 2025 and here you can find the save the date.
Projects
1. On-line Training and Education Portal for HER2-Low Scoring in Breast Cancer
In a recent phase-III clinical trial (Destiny Breast-04), trastuzumab deruxtecan, an antibody-drug conjugate has been shown to have antitumour activity in breast cancer expressing low levels of HER2. The clinical need to differentiate HER2 1+ expressing tumours from those expressing below that level has not previously been present. Inaccurate assessment of HER2 status will have a significant impact on patient treatment outcomes. To address the clear need to deliver additional education and training to pathologists, is aimed at allowing them to
differentiate breast cancer tumours expressing HER2 at the 1+ level accurately and reproducibly. The project will establish an on-line portal to allow theoretical and practical education and training in the assessment of HER2 expression in breast cancer. The project will start in the third quarter of 2024.
2. Adoption of Cancer Omics and Precision Oncology in the patient’s journey: the perspective of a forum of academia, NGOs and industry
The access to novel therapies in precision oncology is strictly associated with the availability of biomarker testing. Different limitations are causing disparities in the access to novel therapeutic options. This project aims
to identify strategies and solutions for accelerating the implementation of precision oncology on a global scale, with a special focus on low-middle income Countries. The project will bring together Academia, NGOs and
Pharmaceutical and Diagnostics Companies with the aim of identifying the existing barriers, analyzing technological and social improvements that could facilitate the global application of precision oncology. The final
goal will be the definition of a concrete action plan to implement access to precision oncology worldwide. The project will start in the third quarter of 2024.
3. A new model of EQA to harmonize clinical recommendations for Molecular Tumor Boards.
The management of cancer patients is becoming more dependent on the integration of molecular pathology findings with clinical features. The multiple challenges faced in this passage led to the creation of MTBs,
multidisciplinary groups that merge molecular and clinical data from cancer patients to identify the optimal therapeutic strategy. Currently, MTBs are based on unstandardized, largely manual procedures that lack
homogeneity in several aspects. The need for harmonization in the conception, structure and decisional processes of MTBs could benefit from the organization of a new form of EQA scheme. This EQA would include
the evaluation of the state of the art of MTB organization and of discrepancies/limitations in the interpretation of molecular and clinical data. The project will drive the harmonization and standardization of MTBs to improve patient management and treatment decisions. The project started in the second half of 2024 and is ongoing.
4. Pilot EQA Scheme for Fusion Gene Testing
Third generation therapies targeting fusion genes (for example selpercatinib for RET fusions, pemigatinib for FGFR2 fusions and entrectinib / larotrectinib for NTRK fusions) have received licensing approval and are being offered to patients, irrespective of the tumor type. This represents a step change in cancer treatment and the promising response rates observed suggest the potential for considerable clinical benefits. The EQA scheme aims to support the implementation of fusion gene testing strategy in clinical practice. The project was launched in
October 2021 and the results will be available in 2025.
5. Pilot EQA for Liquid Biopsy Testing for Multiple Markers
Many laboratories are developing testing of cfTNA to detect the presence of pathogenic gene variants in plasma samples. Since the number of clinically relevant targets is increasing, a piolot EQA scheme on plasma samples
has been organized to help laboratories develop and deliver high quality testing. The format comprises of different clinical scenarios to enable the assessment of genotyping accuracy and interpretation of the result. The
project has been launched in 2022 and the final phases of results evaluation is ongoing.
6. Development of EQA for HRD testing in ovarian cancer – Pilot Project
Different methods to detect HRD status are being released and there is a general effort to collect clinical evidence and performance data with these new tests. Consequently, there is a need for EQA provision at the
point of regulatory approval and the start of clinical diagnostic testing. This will facilitate early oversight of the testing process, drive harmonisation, and improve the quality of the testing process. IQN Path wishes to facilitate
a single IQN Path badged pilot EQA scheme for HRD testing in an ovarian cancer setting to ensure that the quality of laboratory testing is audited from the point of clinical test introduction. The program was launched in
the second half of 2023 and the pilot EQA for HRD will be opened in the third quarter of 2024.
Resources
Unlocking the potential of precision medicine in Europe – Improving cancer care through broader access to quality biomarker testing
The Press Release is available here: http://www.iqnpath.org/unlocking-the-potential-of-precision-medicine-in-europe-improving-cancer-care-through-broader-access-to-quality-biomarker-testing/
The Final Report is available here: http://www.iqnpath.org/wp-content/uploads/2021/02/unlocking-the-potential-of-precision-medicine-in-europe.pdf
The summary of the Report and its infographic can be found here: http://www.iqnpath.org/wp-content/uploads/2021/02/Biomarker-Testing-Summary-Final-Version.pdf
The findings of the study, presented by L.E.K. Consulting, were discussed during a Webinar held in February 2021 and the recorded version can be assessed here:
https://www.youtube.com/watch?v=TWlmrZagp0U&feature=youtu.be
Nicola Normanno presented the results of the project at the ESMO Congress in Paris on 18 September 2021:
Improving Cancer Care through Broader Access to Quality Biomarker Testing – An IQN Path, ECPC and EFPIA Initiative
The abstract is available here.
The presentation is available here.
The presentation was furthermore highlighted in the article of ESMO Daily Reporter “The tipping point of cancer biomarker quality”.