Guardant Health has secured the US Food and Drug Administration (FDA) approval for its Guardant360 CDx for tumour mutation profiling in patients with any solid malignant neoplasm.
Tumour mutation profiling is also known as comprehensive genomic profiling (CGP) and solid malignant neoplasms are commonly called cancerous tumours.
The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib).
It is said to offer patients and clinicians a simple, faster blood test for personalised treatment options.
Guardant Health CEO Helmy Eltoukhy said: “The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat.
“Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test.
The FDA approval of Guardant360 CDx is based on data from Phase 3 clinical trials
The US regulatory agency has approved Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib).
The FDA approval of Guardant360 CDx was supported by the clinical and analytical validation data from Phase 3 clinical trials, FLAURA and AURA3.
The Phase 3 trials evaluated more than 5,000 samples from non-small cell lung cancer patients for treatment with Tagrisso (osimertinib) using the Guardant360 CDx, showing a consistent progression-free survival rates, compared to traditional biomarker testing, said the company.
The company is also developing Guardant360 CDx as a companion diagnostic for investigational products being developed by its industry partners Amgen, Janssen, and Radius Health.
Moffitt Cancer Centre chemical biology and molecular medicine programme co-leader Jhanelle Gray said: “Personalized medicines such as Tagrisso have been truly life-changing for many non-small cell lung cancer patients who have certain EGFR mutations and are most likely to benefit from this medicine.
“It is crucial that all patients are comprehensively tested before starting treatment to ensure they receive the most appropriate personalized treatment option available.”
