Identity
- Trade Name
- RESOLUTION ctDx FIRST FDA PMA
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system FDA PMA
Identifiers
- PMA Number
- P210040 FDA PMA
- FDA Product Code
- PQP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Medical Genetics FDA PMA
- FDA Decision
- APWD FDA PMA
The 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. It is intended as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who may benefit from treatment with targeted therapy, specifically for KRAS G12C biomarker status, and to provide tumor mutation profiling for SNVs and deletions in the EGFR gene for use by qualified health care professionals in accordance with professional oncology guidelines.
The test utilizes circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). It is a single-site assay performed at Resolution Bioscience, Inc., and is intended for use with patients previously diagnosed with NSCLC, in conjunction with other laboratory and clinical findings. Genomic findings outside the specified biomarkers are not prescriptive or conclusive for labeled therapeutic use.
Frequently asked questions
What type of specimen is required for the Resolution ctDx FIRST test?
The test requires circulating cell-free DNA (cfDNA) isolated from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs), as specified in the device specifications.
Which genes and biomarkers does the Resolution ctDx FIRST assay detect?
The assay detects and reports single nucleotide variants (SNVs) and deletions in the KRAS and EGFR genes, with specific companion diagnostic indication for KRAS G12C to identify NSCLC patients who may benefit from KRAZATI (adagrasib) therapy.
Is the Resolution ctDx FIRST test performed at multiple sites or a single site?
The Agilent Resolution ctDx FIRST assay is a single-site assay performed exclusively at Resolution Bioscience, Inc., as stated in the device specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210040 | Class III | Active |
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Manufacturer
- Manufacturer
- Exact Sciences Corporation
Sources (1)
- FDA PMA P210040 24 fields · synced Sep 18, 2026