Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Basic Information
- Device Name
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Trade Name
- Signatera CDx
- PMA Number
- P260004
- Device Class
- FDA Class 3
- Product Code
- PQP
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 15, 2026
- Date Received
- January 29, 2026
- Expedited Review
- N
- Docket Number
- FDA-5963
Advisory Committee Statement
SignateraTM CDx is a personalized, tumor-informed, multiplex-PCR and next-generation sequencing (NGS)based assay that detects circulating tumor DNA (ctDNA) molecular residual disease (MRD) from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs), using bespoke assays designed to track somatic variants identified from sequencing of a patients formalin-fixed, paraffin-embedded (FFPE) tumor specimen.SignateraTM CDx is intended to identify patients with ctDNA MRD positive status who may benefit from treatment listed in Table 1, in accordance with the approved therapeutic product labeling.Table 1: SignateraTM CDx Indicated Use and Associated TherapyBiomarker Indication TherapyctDNA MRD Muscle Invasive Bladder Cancer (MIBC) TECENTRIQ® (atezolizumab), TECENTRIQ HYBREZA® (atezolizumab and hyaluronidase-tqjs)
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | FDA class 3 | Unknown |