MRTX - Agilent's liquid biopsy test gets FDA nod for companion diagnostic test to Mirati's Krazati

• The U.S. Food and Drug Administration (FDA) approved Agilent Technologies' ( NYSE: A ) Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to Mirati Therapeutics ( NASDAQ: MRTX ) Krazati which was approved yesterday to treat certain patients with non-small cell lung cancer (NSCLC).
• The test is to identify patients with with NSCLC with have KRAS G12C mutations who may benefit from treatment with Krazati (adagrasib).
• Agilent said it is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved Krazati and was developed in collaboration with Mirati.
• Agilent added that the test uses a propriety technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma. This minimally invasive approach is preferred by 90% of patients with cancer compared to more invasive tissue biopsy tests, according to the company.
• Agilent added that ctDx FIRST has also been approved by the FDA for tumor profiling of the epidermal growth factor receptor (EGFR) gene for use in patients with NSCLC.
• Yesterday, the FDA granted accelerated approval to Krazati to treat adult patients with with KRASG12C-mutated locally advanced or metastatic NSCLC, who have received at least one prior systemic therapy.

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