Agilent Technologies has received approval from the US Food and Drug Administration (FDA) for its Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to detect a type of advanced non-small cell lung cancer (NSCLC) patients.
According to the US-based life science and diagnostics firm, the approval is for the test to be used for identifying NSCLC patients having KRAS G12C mutations who could benefit from treatment with KRAZATI (adagrasib).
Agilent Technologies said that its liquid biopsy companion diagnostic test offers a new minimally invasive blood assay to NSCLC patients and their oncologists to help decide on precision treatment options.
Developed in partnership with Mirati Therapeutics, Agilent Resolution ctDx FIRST is said to be the first liquid biopsy NGS assay cleared by the FDA as a CDx for the former’s newly approved KRAZATI in advanced NSCLC.
The ctDx FIRST assay can identify genomic changes in plasma-derived circulating tumour DNA (ctDNA) by using a novel propriety technology, Agilent Technologies added.
The life science and diagnostics firm claimed that this liquid biopsy test offers a substantially faster turn-around time to potentially fast track treatment decisions in comparison with tissue-based methods.
Agilent Technologies diagnostics and genomics group president Sam Raha said: “Commercialising the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC.
“Agilent values opportunities to partner with Mirati and other pharmaceutical companies in developing clinically relevant NGS-based diagnostics that enhance confidence in targeted cancer therapy.”
When used as a professional service, the test reports consist of broad genomic profiling of 109 genes in four types of alterations including single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions.
Agilent Technologies said that ctDx FIRST is also cleared by FDA for tumour profiling of the epidermal growth factor receptor (EGFR) gene. It is intended for use by health care professionals in accordance with guidelines in oncology patients with NSCLC.
In February 2021, the company rolled out a new Dako SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) kit to detect immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma.
