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Published on: April 11, 2016
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Real-World Performance of a Comprehensive Genomic Profiling Test Optimized for Small Tumor Samples
Scott A Tomlins1, Daniel H Hovelson1, Jennifer M Suga2
1Strata Oncology, Ann Arbor, MI.
JCO Precision Oncology
|September 3, 2021
Summary
Tissue-based comprehensive genomic profiling (CGP) is crucial for advanced cancer treatment selection. An optimized PCR-CGP test successfully provided results for over 94% of limited tissue samples, expanding access to biomarker-guided therapies.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Tissue-based comprehensive genomic profiling (CGP) aids treatment selection in advanced cancer.
- Limited tissue availability can hinder widespread CGP implementation.
Purpose of the Study:
- To establish real-world tissue availability for CGP.
- To assess the performance of CGP on consecutively received samples.
Main Methods:
- Analysis of 32,048 consecutive tumor tissue samples for multiplex PCR-based CGP (PCR-CGP).
- Assessment of sample characteristics and PCR-CGP performance, including exception samples with suboptimal quality.
- Defined successful tests based on prioritized alterations and quality control metrics.
Main Results:
- Over 97% of samples were tested, with 26% classified as exceptions due to input requirements.
- 94.2% of tested samples yielded reportable results, including 80.5% of exceptions.
- High positive predictive value (96.7%) for ERBB2 amplification in challenging samples; 84-88% of prostate and lung cancer samples provided actionable results.
Conclusions:
- Real-world tissue samples for CGP are often limited, necessitating optimized approaches.
- An optimized PCR-CGP test with an inclusive exception policy achieved >94% reportable results.
- This approach can broaden patient access to CGP and biomarker-guided therapies.
