| |
| Device | Guardant360® Liquid CDx |
|---|
| Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
|---|
| Applicant | Guardant Health, Inc.
505 Penobscot Dr.
Redwood City, CA 94063 |
|---|
| PMA Number | P250027 |
|---|
| Date Received | 07/31/2025 |
|---|
| Decision Date | 05/19/2026 |
|---|
| Product Code |
PQP |
| Docket Number | 26M-5824 |
|---|
| Notice Date | 05/19/2026 |
|---|
| Advisory Committee |
Pathology |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | Yes |
|---|
Approval Order Statement
Approval order for Guardant360® Liquid CDxGuardant360® Liquid 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) and insertions and deletions (indels) in 741 genes, copy number amplifications (CNAs) in two genes, copy number loss (CNL) in one gene, and rearrangements in nine genes. Guardant360 Liquid 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 targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling (see approval order for Table 1).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 solid malignant neoplasms. 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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling |
Labeling Part 2 |
|---|
|
|
