Guardant360 CDx
by Guardant Health, Inc. United States PMA
PMA P200010
Product code PQP
Overview
Guardant360 CDx is a qualitative next-generation sequencing-based in vitro diagnostic device. It employs targeted high-throughput hybridization-based capture technology to detect single nucleotide variants (SNVs), insertions and deletions (indels) in 55 genes, copy number amplifications (CNAs) in two genes, and fusions in four genes using circulating cell-free DNA (cfDNA) from plasma derived from peripheral whole blood.
The test is performed as a single-site assay at Guardant Health, Inc., using Streck Cell-Free DNA Blood Collection Tubes (BCTs). It is intended as a companion diagnostic for identifying NSCLC patients eligible for targeted therapy with osimertinib (TAGRISSO®) based on specific EGFR mutations. Authorized under FDA PMA (P200010), it is not a standalone diagnostic and requires correlation with clinical findings and other laboratory tests.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP200010 | Date7 Aug 2020 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- PMA Number
- FDA Product Code
- PQP
- Device Class
- Class III
- Advisory Committee
- Pathology
- FDA Decision
- APPR Approved
Other devices from Guardant Health, Inc.
Questions
What specific mutations does Guardant360 CDx detect in patients with non-small cell lung cancer (NSCLC) to help determine eligibility for osimertinib treatment?
Guardant360 CDx detects EGFR exon 19 deletions, the L858R mutation, and the T790M mutation in circulating cell-free DNA (cfDNA) from plasma. These mutations are key biomarkers used as a companion diagnostic to identify NSCLC patients who may benefit from targeted therapy with osimertinib (TAGRISSO®), as authorized by the FDA under PMA P200010.
How is the sample for Guardant360 CDx collected and processed, and is it a single-use or reusable system?
The test requires plasma derived from peripheral whole blood collected in **Streck Cell-Free DNA Blood Collection Tubes (BCTs)**. The assay itself is performed as a **single-site test at Guardant Health, Inc.**—meaning the entire process, from sample processing to analysis, occurs in their centralized lab. The device itself is not reusable; each patient sample is processed independently as part of the single-site workflow.
If a patient tests negative for the EGFR mutations detected by Guardant360 CDx, what next steps are recommended?
A negative result does not rule out the presence of these mutations in the tumor, so the FDA-authorized labeling directs clinicians to **reflex to tissue biopsy testing** for the same EGFR biomarkers (exon 19 deletions, L858R, and T790M) using an **FDA-approved tumor tissue test**, if feasible. This ensures comprehensive assessment for osimertinib eligibility.
Beyond EGFR mutations, what broader genomic insights does Guardant360 CDx provide for oncology patients?
While its primary FDA-authorized use is for EGFR mutations in NSCLC to guide osimertinib treatment, Guardant360 CDx also detects **single nucleotide variants (SNVs) and insertions/deletions (indels) in 55 genes**, **copy number amplifications in two genes**, and **gene fusions in four genes** in circulating cfDNA. These findings are intended for **tumor mutation profiling** to aid qualified healthcare professionals in oncology, per professional guidelines, though they are not prescriptive for specific therapies beyond the labeled use.
Is Guardant360 CDx suitable for patients who cannot undergo a tissue biopsy, and how does plasma testing compare to tissue testing for EGFR T790M?
Yes, plasma testing via Guardant360 CDx is **most appropriate for patients from whom a tumor biopsy cannot be obtained**, particularly for EGFR T790M detection. However, the FDA notes that **clinical data for T790M plasma-positive patients are limited**, and efficacy of osimertinib in this subgroup (plasma-positive but tissue-negative/unknown) has not been established. Tissue biopsy remains the preferred method when feasible, but plasma testing provides a viable alternative in biopsy-unable cases.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P200010