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FDA-approved companion diagnostic

Agilent Resolution ctDx FIRST assay

Liquid biopsy NGS assay using plasma cfDNA to detect KRAS G12C and EGFR variants in advanced NSCLC, guiding selection of targeted treatment options.

Lab-developed CDxMethod: NGSSpecimen: PlasmaBiomarker: KRAS
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About this test

FDA approval details
PMA number
P210040
Supplements
Manufacturer
Resolution Bioscience (Exact Sciences)
Approval date
December 12, 2022
Test specifications
Methodology
NGS
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
KRAS
What this test is

Agilent Resolution ctDx FIRST is an FDA-approved, qualitative, targeted hybrid-capture NGS assay that analyzes circulating cell-free DNA from plasma to detect KRAS G12C and selected EGFR variants in patients with advanced non-small cell lung cancer. This single-site liquid biopsy test helps identify patients who may be eligible for KRAS G12C–directed and EGFR-targeted treatment strategies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)KRASG12CKRAZATI

Performing lab

Resolution Bioscience (Exact Sciences)

Resolution Bioscience is dedicated to developing a highly sensitive, non-invasive liquid biopsy platform that improves cancer diagnostics and monitoring for patients around the world. The company has developed and patented core technology for circulating cell-free DNA NGS analysis. The company is based in Kirkland, Washington.

Order this test

If your organization is connected to Casandra, you can place an electronic order forAgilent Resolution ctDx FIRST assay directly from your existing workflow.

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CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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