Guardant’s Liquid Biopsy Test Receives FDA Approval for J&J’s Rybrevant

Guardant Health’s CDx liquid biopsy test has been approved by the FDA for use as the first companion diagnostic for Johnson & Johnson’s (J&J) lung cancer drug Rybrevant (amivantamab-vmjw).

The test will be used to profile tumor mutations and to identify patients potentially eligible for Rybrevant. The drug was recently approved for locally advanced or metastatic nonsmall-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutation after disease progression during or after platinum-based chemotherapy.

Oncologists can use the test to obtain comprehensive genomic results from a blood sample in seven days.