Abstract 3788
Background
Centralized MammaPrint (MP) and BluePrint (BP) microarray-based genomic tests on FFPE RNA were succesfully translated to a targeted RNA NGS kit that can be performed locally in decentralized sites. Since the launch of the CE-marked MP and BP NGS test, more data has been generated on this platform as well as on the established FDA-cleared microarray platform. Furthermore, decentralized sites worldwide have been onboarded and are certified to locally run the MP and BP NGS test.
Methods
Paired MP and BP results were generated from FFPE RNA samples using the standard microarray as well as the MP and BP NGS test. The results from both platforms were compared to assess the concordance. Since the launch of the MP and BP NGS kit several decentralized sites underwent the onboarding process. As part of the onboarding, these sites processed a set of RNA and FFPE tissue samples previously processed at Agendia using the MP and BP NGS test. A site could only be certified if NGS results showed a 100% concordance with the Agendia results.
Results
To date, over 150 RNA FFPE samples were processed with both microarray and NGS tests and MP/BP results showed concordance above 97%. Onboarding results were available for the decentralized sites. The FASTQ files generated at the sites were uploaded into the cloud-based Agendia Data Analysis Pipeline Tool (ADAPT) to generate MP and BP results. Results showed 100% concordance between Agendia’s central laboratory and the decentralized laboratories.
Conclusions
MP and BP NGS test delivers equivalent results to the standard microarray test. Additionally, NGS results generated at decentralized sites also show extremely high concordance. These results confirm the high quality and robustness of the MP and BP NGS test.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
L. Delahaye: Full / Part-time employment: Agendia. A.T. Witteveen: Full / Part-time employment: Agendia. M. Snel: Full / Part-time employment: Agendia. T. Cavness: Full / Part-time employment: Agendia. B. Chan: Full / Part-time employment: Agendia. L. Mittempergher: Full / Part-time employment: Agendia. A.M. Glas: Full / Part-time employment: Agendia.
Resources from the same session
2888 - Development and validation a nomogram based on pathological microscopic features to predict survival in nasopharyngeal carcinoma and guide treatment decision
Presenter: Kuiyuan Liu
Session: Poster Display session 3
Resources:
Abstract
3607 - Deep learning in nasopharyngeal carcinoma: a retrospective cohort study of 3D convolutional neural networks on magnetic resonance imaging
Presenter: Meng Yun Qiang
Session: Poster Display session 3
Resources:
Abstract
5848 - Combined androgen blockade in patients with advanced androgen receptor–positive salivary gland carcinoma: Exploratory biomarker analyses
Presenter: Chihiro Fushimi
Session: Poster Display session 3
Resources:
Abstract
4484 - Classification of esthesioneuroblastoma (ENB) based on chromosome (chr) arm gain and loss (CNA) in the setting of a hypomutated genomic landscape
Presenter: Russell Madison
Session: Poster Display session 3
Resources:
Abstract
5753 - Trastuzumab plus docetaxel in patients with advanced HER2–positive salivary duct carcinoma: Exploratory biomarker analyses
Presenter: Hideaki Takahashi
Session: Poster Display session 3
Resources:
Abstract
3373 - Development and characterization of salivary gland cancer organoid cultures
Presenter: Wim Boxtel
Session: Poster Display session 3
Resources:
Abstract
3118 - A parent-of-origin effect of the RB1 mutations in retinoblastoma with low penetrance and variable expressivity
Presenter: Ekaterina Alekseeva
Session: Poster Display session 3
Resources:
Abstract
4512 - The humanistic burden reported by patients diagnosed with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) in Europe
Presenter: Prianka Singh
Session: Poster Display session 3
Resources:
Abstract
3961 - Concurrent Chemotherapy and External Radiation Therapy: An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus Three Weekly Cisplatin and Radical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: CONCERT trial
Presenter: ATUL SHARMA
Session: Poster Display session 3
Resources:
Abstract
3973 - A randomized phase II study on the OPTimization of IMmunotherapy in squamous carcinoma of the head and neck (SCCHN) – OPTIM (AIO-KHT-0117)
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract