Agilent Technologies, Inc. (A) announced Monday an agreement with Quest Diagnostics (DGX), a diagnostic information services company, to enable providers and patients throughout the U.S. to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test.
Healthcare providers can now order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records (EMRs). They may direct patients to provide specimens at one of Quest's 2,100 patient service centers across the U.S.
The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington.
ctDx FIRST is the first liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI. It is a minimally invasive liquid biopsy test option as a CDx for KRAZATI.
KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.
As a professional service, the ctDx FIRST test report includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions.
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