Identity
- Trade Name
- Oncomine Dx Target Test FDA PMA
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system FDA PMA
Identifiers
- PMA Number
- P160045 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 Target Test is a qualitative in vitro diagnostic test classified as a next-generation sequencing oncology panel for somatic or germline variant detection. It employs targeted high-throughput, parallel-sequencing technology to identify single nucleotide variants (SNVs), deletions in 23 genes from DNA, and fusions in ROS1 from RNA, using formalin-fixed paraffin-embedded (FFPE) tumor tissue samples. The test is designed to aid in selecting targeted therapies for patients with non-small cell lung cancer (NSCLC) based on specific genetic variants.
This device is intended for use with the Ion PGM Dx System and requires DNA or RNA isolated from FFPE NSCLC tissue samples. It is not indicated for standalone diagnostic, screening, monitoring, risk assessment, or prognostic purposes. The test has established analytical performance for variants listed in Table 2, though its use for therapies beyond those in Table 1 is restricted to patients who have exhausted other treatment options. The device holds FDA_PMA authorization (PMA Number: P160045) and is classified as a Class III medical device.
Frequently asked questions
What specific genetic variants does the Oncomine Dx Target Test detect to help guide treatment decisions for non-small cell lung cancer (NSCLC) patients?
The Oncomine Dx Target Test detects single nucleotide variants (SNVs) and deletions in 23 genes from DNA, as well as fusions in ROS1 from RNA. For treatment selection, it specifically identifies variants in BRAF (V600E), ROS1 (fusions), and EGFR (L858R, Exon 19 deletions) to aid in choosing targeted therapies like TAFINLAR®/MEKINIST®, XALKORI®, or IRESSA® for NSCLC patients. These variants are listed in Table 1 of the device’s labeling, and the test is authorized for use only in these contexts.
Is the Oncomine Dx Target Test designed to work with any type of tissue sample, or is it limited to formalin-fixed paraffin-embedded (FFPE) NSCLC specimens?
The test is exclusively designed for formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from NSCLC patients. It requires DNA or RNA isolated from these samples and is not validated or intended for use with other tissue types, such as germline samples or non-NSCLC tissues. This restriction is explicitly noted in the device’s labeling.
How does the Oncomine Dx Target Test differ from other genetic testing options for NSCLC, particularly in terms of its intended use?
Unlike standalone diagnostic tests, the Oncomine Dx Target Test is not intended for screening, monitoring, risk assessment, or prognosis—it is limited to aiding treatment selection for NSCLC patients with specific genetic variants (e.g., EGFR mutations) when considering targeted therapies like those listed in Table 1. It also requires use with the Ion PGM Dx System and focuses on next-generation sequencing (NGS) for somatic or germline variants in predefined genes, unlike broader or less targeted assays.
What happens if a variant is detected that isn’t listed in Table 1 of the device’s labeling—can it still be used to guide therapy?
No, the test’s labeling restricts use of unlisted variants (from Table 1) for therapy selection to patients who have exhausted all other treatment options, including those listed in Table 1. Variants in Table 2 (e.g., specific KRAS, MET, or PIK3CA mutations) have established analytical performance but are not approved for guiding therapy unless no other options remain. Clinicians must follow this restriction to ensure safe and compliant use.
Does the Oncomine Dx Target Test require any specific system or equipment to function, and what role does the Ion PGM Dx System play?
Yes, the Oncomine Dx Target Test requires the Ion PGM Dx System for processing and sequencing the isolated DNA/RNA from FFPE NSCLC samples. The Ion PGM Dx System is the authorized platform for running the test, as the device’s labeling explicitly states it is intended for use only with this system. Without it, the test cannot be performed.
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 | P160045 | Class III | Active |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
Sources (1)
- FDA PMA P160045 24 fields · synced Sep 18, 2026