Agilent Receives FDA Approval for Liquid Biopsy Test for Lung Cancer

Agilent Technologies has received U.S. Food and Drug Administration (FDA) approval for its Agilent Resolution ctDx FIRST test. This test is designated as a liquid biopsy companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) who have KRAS G12C mutations. These patients may be eligible for treatment with the newly approved KRAZATI medication.

This marks the first FDA-approved next-generation sequencing (NGS) liquid biopsy assay to function as a companion diagnostic for the KRAZATI drug in advanced NSCLC. Agilent developed the test in collaboration with Mirati Therapeutics. Additionally, the FDA has approved ctDx FIRST for tumor profiling of the EGFR gene in NSCLC patients.

Lung cancer is a leading cause of cancer mortality in the U.S. Approximately 14% of NSCLC patients harbor a KRAS G12C mutation, and about 32% have an EGFR gene mutation. The new, minimally invasive blood test offers patients and their oncologists a tool to inform precision treatment options.

The ctDx FIRST assay employs proprietary technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma. This liquid biopsy approach is generally preferred by patients over more invasive tissue biopsies and can expedite treatment decision-making.