Abstract 234P
Background
The MammaPrint® 70-gene signature (70GS) risk of recurrence and BluePrint® 80-gene signature (80GS) of molecular subtyping are utilized in personalized treatment planning of early-stage breast cancer patients. These gene expression assays were developed with microarray (MA) and have been translated into Next Generation Sequencing (NGS) using targeted RNA-sequencing and CE marked. Equivalence between MA and NGS has been shown with NGS in centralized and decentralized setting. Here we present extended data from multiple global sites and report performance on equivalence.
Methods
A total of 1,164 paired results from MA and NGS test corresponding to 969 unique samples were used in this study. All MA results were generated in Agendia’s central laboratory. 689 NGS results were generated at Agendia, and 475 NGS results were generated across 10 external partner sites in 5 countries. Comparisons of the test indices and result categories were conducted. Additionally, NGS testing from two independent RNA isolations was performed and concordance was evaluated among 49 samples to assess the impact of different isolations on 70GS results. 70GS risk categories include Low Risk and High Risk. 80GS molecular subtypes include Basal-, Luminal-, and HER2-type.
Results
Among 1,164 results, 1,158 of them passed NGS quality controls (success rate 99.5%). Comparing MA and NGS results, 70GS had a high risk percent agreement of 94.3% and a low risk percent agreement of 94.6%. There was a perfect concordance among 80GS molecular subtypes. In addition to risk assessment, 70GS and 80GS indices had significant high correlation between MA and NGS results (Pearson correlation coefficient (r) of 0.98 for 70GS, Basal, Luminal, and 0.85 for HER2, p < 2.20e-16). In addition, two independent RNA isolations confirmed high concordance (93.9%) on 70GS results.
Conclusions
The NGS version of the MammaPrint® 70GS and BluePrint® 80GS test is equivalent to the centralized microarray test, as demonstrated by results from various laboratories globally. This enables an accurate decentralized solution to breast cancer care fostering worldwide accessibility to reliable genomic testing.
Legal entity responsible for the study
Agendia Inc.
Funding
Agendia Inc.
Disclosure
E. Schuler: Financial Interests, Personal, Full or part-time Employment: ZOTZ|KLIMAS MVZ Düsseldorf-Centrum GbR Germany. S. Uygun, L. Mittempergher, D. Pronin, S. Mee, S. Bao, T. Cavness, A. Witteveen, A. Glas: Financial Interests, Personal, Full or part-time Employment: Agendia.