On August 12, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the U.S. Food and Drug Administration (FDA) has approved its Guardant360 CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC) whose tumors 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 (Press release, Guardant Health, AUG 12, 2022, https://www.businesswire.com/news/home/20220811005816/en/Guardant-Health-Receives-FDA-Approval-for-Guardant360%C2%AE-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZeneca%E2%80%99s-ENHERTU%C2%AE-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations [SID1234618269]).

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The approval means that Guardant360 CDx, a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood, is validated as a CDx assay to identify NSCLC patients who have an activating HER2 mutation (SNVs and exon 20 insertions) and may benefit from treatment with ENHERTU. Mutations in the HER2 gene, also called ERBB2, drive approximately 2-4% of non-squamous NSCLC.1 Non-small cell lung cancer represents about 82% of all lung cancer,2 which is the leading cause of cancer death in the U.S.3

"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," said Helmy Eltoukhy, Guardant Health co-CEO. "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."

Guardant360 CDx

For oncologists, the FDA-approved Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines.

Since being introduced as a laboratory developed test (LDT), the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 300 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 300,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.