Guardant360 CDx is a next-generation sequencing (NGS)-based assay that uses blood-derived circulating tumour DNA to identify genomic alterations.
Guardant Health has secured US FDA’s approval for its Guardant360 CDx liquid biopsy test. (Credit: Darko Stojanovic from Pixabay)
Precision oncology company Guardant Health has obtained key approval for its Guardant360 CDx liquid biopsy test from the US Food and Drug Administration (FDA).
The test was approved as a companion diagnostic (CDx) for ENHERTU in treating patients with metastatic or unresectable HER2-mutant non-small cell lung cancer (NSCLC) with tumours exhibiting activating HER2 (ERBB2) mutations.
ENHERTU (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody drug conjugate (ADC) developed by Daiichi Sankyo and AstraZeneca.
According to Guardant Health, with this approval, Guardant360 CDx is validated as a CDx assay to detect patients with NSCLC who have an activating HER2 mutation.
Guardant360 CDx is a next-generation sequencing (NGS)-based assay that uses blood-derived circulating tumour DNA to identify genomic alterations.
It delivers comprehensive genomic results from a straightforward blood draw in seven days. This will enable the oncologists to quickly obtain clinically relevant information in time to match patients to the best personalised treatment, said the company.
Guardant Health co-CEO Helmy Eltoukhy said: “This is great news for metastatic NSCLC patients with activating HER2 mutations, who now have, for the first time, an approved treatment for their cancer, but also the first blood-based companion diagnostic in Guardant360 CDx.
“We are proud to offer our Guardant360 CDx liquid biopsy as a companion diagnostic so that patients can access comprehensive genomic profiling to see if they are eligible to receive this therapy.”