Bruna Pellini, MD, on the Approval of the Guardant360 CDx

News
Video

The liquid biopsy was approved by the FDA for comprehensive genomic profiling in patients with any solid malignant neoplasm.

The Guardant360 CDx was approved by the FDA for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, the developer of the liquid biopsy.

Further, the tool is also approved as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with osimertinib (Tagrisso).

“Approval of a companion diagnostic that uses a liquid biopsy and leverages next-generation sequencing marks a new era for mutation testing,” Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release.2 “In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms.”

The approval was based on clinical and validation data observed from more than 5000 samples. Moreover, in a retrospective analysis of data from 2 pivotal phase 3 clinical trials, FLAURA and AURA3, patients with NSCLC identified for treatment with osimertinib using the liquid biopsy demonstrated progression-free survival (PFS) rates consistent with those identified using traditional biomarker testing.

In an interview with CancerNetwork®, Bruna Pellini, MD, assistant member in the Department of Thoracic Oncology at Moffitt Cancer Center, discussed the approval of the Guardant360 CDx and what the tool offers for patients.

This segment comes from the CancerNetwork® portion of the MJH Life Sciences Medical World News, airing daily on all MJH Life Sciences channels.

References:
1. Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers [news release]. Redwood City, California. Published August 7, 2020. Accessed September 17, 2020. https://investors.guardanthealth.com/news-releases/news-release-details/guardant-health-guardant360r-cdx-first-fda-approved-liquid.

2. FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test [news release]. Published August 7, 2020. Accessed September 17, 2020.

Recent Videos
According to John Henson, MD, “What we need are better treatments to control the [brain] tumor once it’s detected.”
First-degree relatives of patients who passed away from pancreatic cancer should be genetically tested to identify their risk for the disease.
Destigmatizing cancer care for incarcerated patients may help ensure that they feel supported both in their treatment and their humanity.
A lower percentage of patients who were released within 1 year of incarceration received guideline-concurrent care vs incarcerated patients.
A collaboration between the Connecticut Departments of Health and Corrections and the COPPER Center aimed to improve outcomes among incarcerated patients.
Computational models help researchers anticipate how ADCs may behave in later lines of development, while they are still in the early stages.
ADC payloads with high levels of potency can sometimes lead to higher levels of toxicity, which can eliminate the therapeutic window for patients with cancer.
According to Greg Thurber, PhD, target-mediated uptake is the biggest driver of efficacy for antibody-drug conjugates as a cancer treatment.
Co-hosts Kristie L. Kahl and Andrew Svonavec highlight what to expect at the 43rd Annual Chemotherapy Foundation Symposium, such as new chemotherapeutics and targeted therapies.
In neuroendocrine tumor management, patients with insulinoma may be at risk of severe hypoglycemia following receipt of GLP-1 receptor agonists.
Related Content
Rising cancer diagnoses in the US highlight urgent needs for improved oncology education, workforce distribution, and care infrastructure, especially in rural areas.

A Decline in the US Oncology Workforce: What Will the Next Decade Bring?

Julie M. Vose, MD, MBA
December 2nd 2025
Article

Rising cancer diagnoses in the US highlight urgent needs for improved oncology education, workforce distribution, and care infrastructure, especially in rural areas.

Decision-Making Capacity: The Ethical Core of Patient-Centered Oncology

Decision-Making Capacity: The Ethical Core of Patient-Centered Oncology

Daniel C. McFarland, DO;Louis P. Voigt, MD;Yesne Alici, MD
November 24th 2025
Podcast

Daniel C. McFarland, DO, is joined by Louis P. Voigt, MD, and Yesne Alici, MD, who focused on decision-making capacity and patient-centered care.

PAS-004 was deemed safe and tolerable when given in 37 mg capsules, so the trial will proceed to administer the agent in 45 mg capsules.

Cohort 7 of Novel MEK Inhibitor Trial Completed for MAPK Pathway-Driven Tumors

Tim Cortese
November 25th 2025
Article

PAS-004 was deemed safe and tolerable when given in 37 mg capsules, so the trial will proceed to administer the agent in 45 mg capsules.

Experts discussed supportive care and why it should be integrated into standard oncology care.

How Supportive Care Methods Can Improve Oncology Outcomes

Declan Walsh, MD;Denise B. Reynolds, RD;Adam Friedman, MD, FAAD;Daniel C. McFarland, DO;Michelle Fingeret, PhD;Christian J. Nelson, PhD;William S. Breitbart, MD
November 10th 2025
Podcast

Experts discussed supportive care and why it should be integrated into standard oncology care.

Novel Agent Yields Promising Results in MAPK-Associated Solid Tumors

Novel Agent Yields Promising Results in MAPK-Associated Solid Tumors

Ariana Pelosci
November 21st 2025
Article

Partial responses and stable disease were observed with PAS-004 in patients with advanced solid tumors harboring RAS, NF1, or RAF mutations.

Results from the C-POST trial showed that cemiplimab improved DFS vs placebo in patients with CSCC at high risk of recurrence following surgery and radiation.

EC Approves Adjuvant Cemiplimab in CSCC at High Risk of Recurrence

Tim Cortese
November 20th 2025
Article

Results from the C-POST trial showed that cemiplimab improved DFS vs placebo in patients with CSCC at high risk of recurrence following surgery and radiation.