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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSignatera™ CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantNatera, Inc.
13011a Mccallen Pass
Austin, TX 78753
PMA NumberP260004
Date Received01/29/2026
Decision Date05/15/2026
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT04660344
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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)
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