{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-31",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P260004",
      "supplement_number": "",
      "applicant": "Natera, Inc.",
      "street_1": "13011a Mccallen Pass",
      "street_2": "",
      "city": "Austin",
      "state": "TX",
      "zip": "78753",
      "zip_ext": "",
      "generic_name": "Next generation sequencing oncology panel, somatic or germline variant detection system",
      "trade_name": "Signatera™ CDx",
      "product_code": "PQP",
      "advisory_committee": "PA",
      "advisory_committee_description": "Pathology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2026-01-29",
      "decision_date": "2026-05-15",
      "docket_number": "FDA-5963",
      "fed_reg_notice_date": "2026-05-26",
      "decision_code": "APPR",
      "ao_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\tIndication \tTherapyctDNA MRD\tMuscle Invasive Bladder Cancer (MIBC)\tTECENTRIQ® (atezolizumab), TECENTRIQ HYBREZA® (atezolizumab and hyaluronidase-tqjs)",
      "openfda": {
        "registration_number": [
          "3010679023",
          "3030654068",
          "3013200421",
          "3003218906",
          "3010889807",
          "3011104381",
          "3003335080",
          "3007287152",
          "3017020141",
          "3012090384",
          "3020703032",
          "3031598391"
        ],
        "fei_number": [
          "3010679023",
          "3030654068",
          "3013200421",
          "3003218906",
          "3008335090",
          "3010889807",
          "3011104381",
          "3003335080",
          "3007287152",
          "3012090384",
          "3031598391",
          "3016560486"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}