Identity
- Trade Name
- cobas EGFR MUTATION TEST v2 FDA PMA
- Generic Name
- Somatic gene mutation detection system FDA PMA
Identifiers
- PMA Number
- P150047 FDA PMA
- FDA Product Code
- OWD FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APCB FDA PMA
The cobas EGFR Mutation Test v2 is a real-time PCR system for the qualitative detection of specific mutations in the epidermal growth factor receptor (EGFR) gene. It is designed for use in non-small cell lung cancer (NSCLC) patients to identify mutations in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma.
This test is supplied with the cobas DNA Sample Preparation Kit for FFPET specimens and the cobas cfDNA Sample Preparation Kit for plasma specimens, processed on the cobas z 480 analyzer for automated amplification and detection. It is intended for use as a companion diagnostic to aid in selecting NSCLC patients for targeted therapies, with regulatory authorization through an FDA Premarket Approval (PMA). The test is not intended for drug safety or efficacy confirmation for mutations beyond those specified in the approved labeling.
Frequently asked questions
What types of samples can the cobas EGFR Mutation Test v2 analyze, and how are they prepared for testing?
The cobas EGFR Mutation Test v2 analyzes DNA from two sample types: formalin-fixed paraffin-embedded tumor tissue (FFPET) and circulating-free tumor DNA (cfDNA) extracted from plasma. For FFPET, the cobas DNA Sample Preparation Kit is used for manual processing, while plasma specimens require the cobas cfDNA Sample Preparation Kit. Both prepared samples are then automatically amplified and detected using the cobas z 480 analyzer.
Is the cobas EGFR Mutation Test v2 intended for use in determining drug safety or efficacy beyond the specified mutations?
No, the test is explicitly designed as a companion diagnostic to aid in selecting NSCLC patients for targeted therapies *only* for the mutations listed in the approved labeling. It is not intended for confirming drug safety or efficacy for mutations beyond those specified in the approved therapeutic product labeling, such as those in Table 2 of the documentation.
What specific mutations in the EGFR gene does the cobas EGFR Mutation Test v2 detect, and how does this vary by sample type?
The test detects defined EGFR mutations in non-small cell lung cancer (NSCLC) patients, including exon 19 deletions and L858R for FFPET and plasma samples (linked to TARCEVA® and TAGRISSO® therapies). Plasma samples also detect T790M for TAGRISSO®, while FFPET samples detect additional mutations like G719X, exon 20 insertions, S768I, and L861Q for both drugs. The approved labeling specifies which mutations correlate with eligibility for each therapy.
How is the cobas EGFR Mutation Test v2 regulated, and what does this mean for clinical use?
The test holds an FDA Premarket Approval (PMA), meaning it has undergone rigorous review to ensure safety and effectiveness as a companion diagnostic for selecting NSCLC patients for targeted therapies. Clinically, this means it can only be used as specified in the approved labeling—primarily to guide treatment decisions for TARCEVA® and TAGRISSO®—and not for broader mutation analysis or drug safety confirmation.
Are there any special handling or storage requirements for the sample preparation kits included with the cobas EGFR Mutation Test v2?
The documentation does not specify storage or handling details for the cobas DNA Sample Preparation Kit (for FFPET) or the cobas cfDNA Sample Preparation Kit (for plasma). However, since these kits are part of the test system, they should be stored according to the manufacturer’s instructions provided in the accompanying literature, typically under controlled conditions (e.g., refrigeration or room temperature) to maintain integrity until use.
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 | P150047 | Class III | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P150047 24 fields · synced Sep 18, 2026