Patient-centric thresholding of Cobas® EGFR mutation Test v2 for surveillance of EGFR-mutated metastatic non-small cell lung cancer Article Swipe
Jonas Claus
,
Dieter De Smet
,
Joke Breyne
,
Janusz Wesolowski
,
Ulrike Himpe
,
Ingel Demedts
,
Geert A. Martens
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1038/s41598-024-68350-6
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1038/s41598-024-68350-6
Cobas EGFR mutation Test v2 was FDA-approved as qualitative liquid biopsy for actionable EGFR variants in non-small cell lung cancer (NSCLC). It generates semiquantitative index (SQI) values that correlate with mutant allele levels, but decision thresholds for clinical use in NSCLC surveillance are lacking. We conducted long-term ctDNA monitoring in 20 subjects with EGFR-mutated NSCLC; resulting in a 155 on-treatment samples. We defined optimal SQI intervals to predict/rule-out progression within 12 weeks from sampling and performed orthogonal calibration versus deep-sequencing and digital PCR. SQI showed significant diagnostic power (AUC 0.848, 95% CI 0.782-0.901). SQI below 5 (63% of samples) had 93% (95% CI 87-96%) NPV, while SQI above 10 (25% of samples) had 69% (95% CI 56-80%) PPV. Cobas EGFR showed perfect agreement with sequencing (Kappa 0.860; 95% CI 0.674-1.00) and digital PCR. SQI values strongly (r: 0.910, 95% 0.821-0.956) correlated to mutant allele concentrations with SQI of 5 and 10 corresponding to 6-9 (0.2-0.3%) and 64-105 (1.1-1.6%) mutant allele copies/mL (VAF) respectively. Our dual-threshold classifier of SQI 0/5/10 yielded informative results in 88% of blood draws with high NPV and good overall clinical utility for patient-centric surveillance of metastatic NSCLC.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1038/s41598-024-68350-6
- OA Status
- gold
- Cited By
- 5
- References
- 25
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4401369468
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4401369468Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1038/s41598-024-68350-6Digital Object Identifier
- Title
-
Patient-centric thresholding of Cobas® EGFR mutation Test v2 for surveillance of EGFR-mutated metastatic non-small cell lung cancerWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-08-06Full publication date if available
- Authors
-
Jonas Claus, Dieter De Smet, Joke Breyne, Janusz Wesolowski, Ulrike Himpe, Ingel Demedts, Geert A. MartensList of authors in order
- Landing page
-
https://doi.org/10.1038/s41598-024-68350-6Publisher landing page
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1038/s41598-024-68350-6Direct OA link when available
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Mutation, Lung cancer, Medicine, Thresholding, Cancer, Cancer research, Oncology, Computational biology, Bioinformatics, Biology, Internal medicine, Genetics, Computer science, Gene, Artificial intelligence, Image (mathematics)Top concepts (fields/topics) attached by OpenAlex
- Cited by
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5Total citation count in OpenAlex
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2025: 4, 2024: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.(1.1-1.6%) | 157 |
| abstract_inverted_index.actionable | 12 |
| abstract_inverted_index.classifier | 165 |
| abstract_inverted_index.correlated | 140 |
| abstract_inverted_index.diagnostic | 86 |
| abstract_inverted_index.metastatic | 189 |
| abstract_inverted_index.monitoring | 48 |
| abstract_inverted_index.orthogonal | 76 |
| abstract_inverted_index.sequencing | 124 |
| abstract_inverted_index.thresholds | 35 |
| abstract_inverted_index.0.674-1.00) | 129 |
| abstract_inverted_index.calibration | 77 |
| abstract_inverted_index.informative | 170 |
| abstract_inverted_index.progression | 68 |
| abstract_inverted_index.qualitative | 8 |
| abstract_inverted_index.significant | 85 |
| abstract_inverted_index.0.821-0.956) | 139 |
| abstract_inverted_index.EGFR-mutated | 53 |
| abstract_inverted_index.FDA-approved | 6 |
| abstract_inverted_index.on-treatment | 59 |
| abstract_inverted_index.surveillance | 41, 187 |
| abstract_inverted_index.0.782-0.901). | 92 |
| abstract_inverted_index.corresponding | 151 |
| abstract_inverted_index.respectively. | 162 |
| abstract_inverted_index.concentrations | 144 |
| abstract_inverted_index.dual-threshold | 164 |
| abstract_inverted_index.deep-sequencing | 79 |
| abstract_inverted_index.patient-centric | 186 |
| abstract_inverted_index.predict/rule-out | 67 |
| abstract_inverted_index.semiquantitative | 23 |
| cited_by_percentile_year.max | 98 |
| cited_by_percentile_year.min | 90 |
| corresponding_author_ids | https://openalex.org/A5047566599 |
| countries_distinct_count | 2 |
| institutions_distinct_count | 7 |
| corresponding_institution_ids | https://openalex.org/I32597200 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.5799999833106995 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.87532181 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |