Guardant360 CDx
Companion Diagnostic
Guardant360 CDx is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
Guardant360 CDx is an FDA‐approved liquid biopsy test that performs comprehensive genomic profiling using circulating tumor cell‐free DNA (cfDNA) from a blood sample. It identifies somatic mutations across a broad panel of cancer‐related genes to guide selection of targeted therapies, including companion diagnostic indications: KRAS G12C for LUMAKRAS (sotorasib), ERBB2 activating mutations for ENHERTU (fam‑trastuzumab deruxtecan‑nxki), ESR1 missense mutations for ORSERDU (elacestrant), and EGFR alterations for TAGRISSO (osimertinib), RYBREVANT (amivantamab), as well as MSI‐High status for immunotherapy eligibility. The test delivers results within approximately 7 calendar days, offering a less invasive and faster alternative to tissue biopsy for oncologic decision‑making.
Special Instructions
Not provided.
Limitations
Not provided.
Methodology
NGS (Targeted)
Biomarkers
Indel • Mutation
Copy Number
Fusion
Result Turnaround Time
7 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
20 mL whole blood
Minimum Volume
4 mL whole blood (in each of two tubes)
Container
Streck tubes (kit)
Collection Instructions
Use Streck tubes supplied in kit; must be used.
Storage Instructions
Ambient; ship with room temperature gel pack; do not freeze or refrigerate.
