Identity
- Trade Name
- Oncomine Dx Express Test FDA PMA
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system FDA PMA
Identifiers
- PMA Number
- P240040 FDA PMA
- FDA Product Code
- PQP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology to detect genetic alterations in DNA and RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor samples. It identifies substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes.
The test is intended to be used as a companion diagnostic to identify patients who may benefit from specific targeted therapies and to provide tumor mutation profiling information for qualified health care professionals treating patients with solid malignant neoplasms. It is supplied as a single-use test and requires FDA PMA authorization for use.
Frequently asked questions
What is the purpose of the Oncomine Dx Express Test?
The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that detects genetic alterations in DNA and RNA from FFPE tumor samples. It identifies substitutions, insertions, deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes to help identify patients who may benefit from specific targeted therapies.
How is the Oncomine Dx Express Test supplied?
The Oncomine Dx Express Test is supplied as a single-use test. It requires FDA PMA authorization for use and is designed to be used with the Genexus Dx Integrated Sequencer for analyzing formalin-fixed, paraffin-embedded tumor samples.
What types of genetic alterations can the Oncomine Dx Express Test detect?
The test can detect substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes from DNA and RNA isolated from formalin-fixed, paraffin-embedded tumor samples using targeted next-generation sequencing technology.
Who should use the Oncomine Dx Express Test?
The test is intended to be used by qualified health care professionals as a companion diagnostic to identify patients who may benefit from specific targeted therapies and to provide tumor mutation profiling information for patients with solid malignant neoplasms.
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 | P240040 | Class III | Active |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
Sources (1)
- FDA PMA P240040 23 fields · synced Sep 18, 2026