Sam Brusco, Associate Editor08.12.22
Precision oncology company Guardant Health has gained U.S. Food and Drug Administration (FDA) approval for its Guardant360 CDx liquid biopsy test as a companion diagnostic (CDx) to choose patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) with tumors that have activating HER2 (ERBB2) mutations for treatment with ENHERTU (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The next-generation sequencing (NGS)-based assay detects genomic changes using circulating tumor DNA from blood, and is now validated as a CDx assay for the aforementioned patients. Mutations in the gene drive about 2-4% of non-squamous NSCLC.
“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,” Helmy Eltoukhy, Guardant Health co-CEO told the press. “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.”
The test generates comprehensive genomic results from a blood draw in seven days. Since being introduced as a laboratory-developed test, the Guardant360 test has been performed over 300,000 times to date.
The next-generation sequencing (NGS)-based assay detects genomic changes using circulating tumor DNA from blood, and is now validated as a CDx assay for the aforementioned patients. Mutations in the gene drive about 2-4% of non-squamous NSCLC.
“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,” Helmy Eltoukhy, Guardant Health co-CEO told the press. “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.”
The test generates comprehensive genomic results from a blood draw in seven days. Since being introduced as a laboratory-developed test, the Guardant360 test has been performed over 300,000 times to date.