On May 21, 2021 Guardant Health, Inc. (Nasdaq: GH) reported that the U.S. Food and Drug Administration (FDA) has approved the Guardant360 CDx liquid biopsy test as the first and only companion diagnostic for Janssen Biotech, Inc.’s (Janssen’s) RYBREVANT (amivantamab-vmjw) (Press release, Guardant Health, MAY 21, 2021, View Source [SID1234580459]).

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The Guardant360 CDx test will be used for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with RYBREVANT after progressing on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in the U.S.1, and NSCLC represents approximately 84 percent of all lung cancers.2 EGFR mutations are present in about one-third of patients with NSCLC,3 and EGFR exon 20 insertion mutations are the third most prevalent mutation type.4 These mutations are highly resistant to chemotherapy and tyrosine kinase inhibitors (TKI)4, and until now, a targeted therapeutic has not existed.

"Today’s FDA approval of Guardant360 CDx as a companion diagnostic for RYBREVANT, the first targeted therapy to treat EGFR exon 20 mutations, is a key milestone for patients who, until now, have had limited treatment options," said Helmy Eltoukhy, Guardant Health CEO. "We are proud to offer our Guardant360 CDx liquid biopsy blood test as a companion diagnostic so that patients may have access to comprehensive genomic profiling in order to see if they are eligible to receive this new treatment."

For oncologists, the FDA-approved Guardant360 CDx 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, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.