Abstract 3523
Background
Cell free DNA (cfDNA) testing of EGFR mutations is widely employed in lung cancer patients. Liquid biopsy testing is highly challenging due to the low level of mutant DNA present with normal DNA. Therefore, cfDNA testing requires quality assessment to ensure patient safety. The international external quality assessment (EQA) provider consortium, IQNPath has delivered a second successful EQA run to determine the standard of cfDNA testing for EGFR mutations.
Methods
Five European EQA providers (AIOM, EMQN, ESP, Gen&Tiss, UKNEQAS), under the umbrella of IQNPath, collaborated to deliver the assessment during 2018-19 to a total of 310 laboratories from 44 countries. A panel of bespoke manufactured plasma samples with varying EGFR mutations at a range of allelic frequencies were validated by a range of methodologies prior to distribution to ensure stability and reproducibility. The EQA samples were supplied for testing and reporting according to laboratory routine protocols. Peer reviewed criteria was applied to assess the standard of genotyping and reporting.
Results
Of the 310 laboratories that had joined the program, 270 submitted the results within the established deadline. Preliminary analysis of the data submitted by participating laboratories showed that low allelic frequency samples were the most challenging and some methods did not detect these mutations. Reporting of such cases often did not address the risk that tumour DNA may have not been tested and limitations of the testing performed was not addressed when reporting the result. The final results of the EQA scheme will be presented at the meeting.
Conclusions
The variability in the standard of genotyping and reporting highlights the need for EQA in this field and educational guidance to ensure the delivery of high-quality clinical service where testing of cfDNA is the only option for clinical management.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
IQNPath.
Funding
IQNPath.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2477 - Antecedent of cancer and mortality after the first ST segment elevation acute myocardial infarction treated with primary coronary angioplasty. A prospective cohort study
Presenter: Irene Sillero
Session: Poster Display session 3
Resources:
Abstract
1894 - Genomic characterisation of locally advanced pancreatic adenocarcinoma
Presenter: Sarah Picardo
Session: Poster Display session 3
Resources:
Abstract
3280 - Comparison of freshly prepared and frozen cells from colorectal cancer surgical samples for phenotyping experiments- a pilot study
Presenter: Sandra Mersakova
Session: Poster Display session 3
Resources:
Abstract
3419 - Hyaluronan (HA) Accumulation in the Tumor Microenvironment (TME) is Increased in Colorectal Cancer (CRC) and Associated with Consensus Molecular Subtypes (CMS) 4 Molecular Subtype
Presenter: Barbara Blouw
Session: Poster Display session 3
Resources:
Abstract
1833 - Evaluation of CT-based radiomics in patients with renal cell carcinoma
Presenter: An Zhao
Session: Poster Display session 3
Resources:
Abstract
5883 - Detection of Double Protein Expression in Diffuse Large B Cell Lymphoma
Presenter: Mohamed Gouda
Session: Poster Display session 3
Resources:
Abstract
5415 - Encyclopedic Tumor Analysis for organ agnostic treatment with Axitinib in combination regimens for advanced cancers
Presenter: Tim Crook
Session: Poster Display session 3
Resources:
Abstract
3297 - Computational model to predict response rate of clinical trials
Presenter: Orsolya Lorincz
Session: Poster Display session 3
Resources:
Abstract
4355 - Analysis of BRCA genes and homologous recombination deficiency (HRD) scores in tumours from patients (pts) with metastatic breast cancer (mBC) in the OlympiAD trial
Presenter: Mark Robson
Session: Poster Display session 3
Resources:
Abstract
2316 - A 3D co-culture platform of breast cancer and patient derived immune cells to analyse the response to chemotherapy and immunotherapies
Presenter: Diana Saraiva
Session: Poster Display session 3
Resources:
Abstract