PMA P260004
- Device
- Signatera™ CDx
- Applicant
- Natera, Inc.
- PMA number
- P260004
- Product code
- PQP
- Decision date
- 2026-05-15
- Classification
- Pathology
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order 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 patient’s 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)
Current openFDA PMA Record#
- Device
- Signatera™ CDx
- Applicant
- Natera, Inc.
- PMA number
- P260004
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-05-15
- Decision code
- APPR
- Date received
- 2026-01-29
- Approval order 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 patient’s 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)