David R. Gandara, MD at MDAnderson discusses Guardant Health’s FDA approval of the Guardant360 CDx which delivers critical genomic information to oncologists from a simple blood draw
Guardant Wellness, Inc. (Nasdaq: GH) estimates that the United States is Guardant360 ® CDx for tumor mutation profiling, also known as systematic genomic profiling (CGP), has been approved by the Food and Drug Administration ( FDA) in patients with any solid malignant neoplasm (cancerous tumor). In order to recognize non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from Tagrisso ® (osimertinib) therapy, Guardant360 CDx is also accepted as a companion diagnosis. Guardant360 CDx provides a simple, quicker blood test to help educate patients and clinicians about customized care options.
The Guardant360 CDx FDA approval was based on data from over 5,000 samples for clinical and analytical validation. In a retrospective review of data from the FLAURA and AURA3 seminal phase III clinical trials, non-small cell lung cancer patients identified with Guardant360 CDx for treatment with Tagrisso (osimertinib) demonstrated progression-free survival rates consistent with those identified using conventional biomarker testing. Since being launched as a laboratory established test (LDT), with more than 150 peer-reviewed publications, the Guardant360 liquid biopsy LDT has been commonly recognized for blood-based CGP.1 More than 7,000 oncologists nationally have used it, and more than 150,000 Guardant360 tests have been conducted to date.1 The test is largely protected by Medicare and many private payers, including ov.
Every year in the United States, more than 600,000 people die from cancer,2 many of whom may have benefited from CGP to lead a more tailored care plan based on a growing list of successful targeted therapies informed by CGP. More new targeted therapies have already been approved by the FDA in 2020 than in previous years. Clinical trials indicate that patients undergoing targeted therapies have increased progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.3-9 Due to many factors, including inadequate biopsy tissue, which is the case with as many as 30 percent of solid cancer patients , clinical acceptance of targeted therapies lags behind medical guidelines.10-12