| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Guardant360 CDx |
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| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
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| Applicant | Guardant Health, Inc.
505 Penobscot Dr.
Redwood City, CA 94063 |
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| PMA Number | P200010 |
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| Supplement Number | S026 |
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| Date Received | 07/23/2025 |
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| Decision Date | 01/15/2026 |
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| Product Code |
PQP |
| Docket Number | 26M-0562 |
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| Notice Date | 01/16/2026 |
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| Advisory Committee |
Pathology |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Guardant360® CDx is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two (2) genes, and fusions in four (4) genes. Guardant360 CDx utilizes circulating cell-free DNA (cfDNA) from plasma of peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the therapies listed in Table 1 in accordance with the approved therapeutic product labeling.A negative result from a plasma specimen does not assure that the patient’s tumor is negative for genomic findings. Patients who are negative for the biomarkers listed in Table 1 should be reflexed to tissue biopsy testing for Table 1 biomarkers using an FDA-approved tumor tissue test, if feasible.*The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore, testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with any solid malignant neoplasm. The test is for use with patients previously diagnosed with cancer and in conjunction with other laboratory and clinical findings.Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.Guardant360 CDx is a single-site assay performed at Guardant Health, Inc. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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