Analytical and Clinical Validation of the Oncomine Dx Express Test, an In Vitro Diagnostic-Labeled Assay, for Genomic Profiling of FFPE Tumor Samples
A new tumor-testing method reliably identifies genetic mutations in cancer samples, matching performance of more complex clinical tests.
This PubMed-indexed validation study examined Analytical and Clinical Validation of the Oncomine Dx Express Test, an In Vitro Diagnostic-Labeled Assay, for Genomic Profiling of FFPE Tumor Samples. The abstract reports that similarly, the ODxET assay showed high clinical concordance with the clinical trial assays for EGFR exon 20 insertions, with a PPA of 97;9%, a NPA of 100%, and an overall percent agreement (OPA) of 98;9%.
What the study was
- Study design
- Validation study
- Population
- Analytical and Clinical Validation of the Oncomine Dx Express Test, an In Vitro Diagnostic-Labeled Assay, for Genomic Profiling of FFPE Tumor Samples.
- Category
- Genomics/Precision Medicine
- Maturity
- Validated
- Journal
- Molecular diagnosis & therapy
Why it surfaced
Validation study with an abstract-supported finding relevant to Precision oncology and genomic medicine; scored conservatively because only the PubMed abstract was reviewed.
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