ctDx FIRST is an FDA approved companion diagnostic to KRAZATITM (adagrasib) for the detection of KRAS G12C in non-small cell lung cancer (NSCLC) and provides tumor mutation profiling for single nucleotide variants (SNVs) and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines.
Additionally, the professional services portion of the test report‡ includes comprehensive genomic profiling on 109 genes across 4 types of alterations.
Using our proprietary technology, we can detect fusions without a priori knowledge§ of the gene partner.1,*
Insight into clinically significant classes of alterations,2 including fusions3-5 and CNAs,6 which have been historically challenging to detect with cfDNA-based tests
Assay PanelMutations (Hover over each mutational type to highlight genes covered)
‡CLIA-certified, not FDA approved
§NRTK3: Only fusions with ETV6 fusion partner are detected
*In conjunction with validated probe placement and tiling density, our proprietary primer extension technology enables capture of fusion partner without knowing the adjacent genomic sequence
††SNV/indels: 64% of genes have full coding sequence (CDS) coverage
The Agilent Resolution ctDx FIRST assay is a qualitative next generation sequencing-based, in vitro diagnostic test that uses targeted hybrid-capture sequencing technology to detect and report single nucleotide variants (SNVs) and deletions in two genes. The Agilent Resolution ctDx FIRST assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib), in accordance with the approved therapeutic labeling. A negative result from a plasma specimen does not assure that the patient's tumor is negative for genomic findings. Patients with NSCLC who are negative for the KRAS G12C biomarker should be reflexed to tissue biopsy testing using an FDA-approved tumor tissue test, if feasible. Additionally, the test is intended to provide tumor mutation profiling for SNVs and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with NSCLC. The test is for use with patients previously diagnosed with NSCLC and in conjunction with other laboratory and clinical findings. Genomic findings other than KRAS G12C are not prescriptive or conclusive for labeled use of any specific therapeutic product. The Agilent Resolution ctDx FIRST assay is a single-site assay performed at Resolution Bioscience, Inc.
1. Data on file. Agilent Technologies, Inc. 2022.
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