FDA-approved companion diagnostic

Signatera CDx

A comprehensive genomic profiling assay used as a companion diagnostic to select patients for targeted therapies across multiple solid tumors.

Lab-developed CDxMethod: NGSSpecimen: PlasmaBiomarker: Multiple genomic alterations
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P260004
Supplements
Manufacturer
Natera
Approval date
May 26, 2026
Test specifications
Methodology
NGS
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
What this test is

Signatera CDx is an in vitro diagnostic test that uses next-generation sequencing to identify genomic alterations in solid tumors. It is approved by the FDA as a companion diagnostic for multiple targeted therapies across tumor types.

Results from this assay help determine whether a patient is eligible for specific therapies based on the genomic profile of their tumor.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Muscle Invasive Bladder Cancer (MIBC)Circulating tumor DNA (ctDNA) molecular residual disease (MRD)ctDNA MRDTECENTRIQ

Performing lab

Natera

San Carlos, CA (05D1082992)

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order for Signatera CDx directly from your existing workflow.

Order via Casandra

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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