Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer
This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics. ctDx FIRST has also been approved by the FDA for tumor profiling of the epidermal growth factor receptor (EGFR) gene for use by qualified health care professionals in accordance with professional guidelines in oncology patients with NSCLC.
As a professional service*, the ctDX FIRST test report includes broad genomic profiling on 109 genes across four types of alterations: single nucleotide variants (SNVs), insertions and deletions (indels), copy number amplifications (CNAs), and fusions.
Lung cancer is one of the most prevalent cancers among men and women in the
The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma. This minimally invasive approach is preferred by 90% of cancer patients compared to more invasive tissue biopsy tests.5 In addition, liquid biopsy overcomes some limitations encountered with tissue-based methods providing a notably faster turn-around time to potentially accelerate treatment decisions.6
“Expanding access to accurate and fast genomic profiling is an essential step to unlocking important medicines for patients in desperate need,” said
“We are thrilled to partner with Agilent as they work to create greater access to efficient, effective and minimally-invasive tests to support clinicians with information that is critical to their patient care,” said
“Commercializing the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC,” said
To learn more about the test and order visit http://www.agilent.com/genomics/ctDxFIRST
* CLIA validated, not FDA approved
American Cancer Society. Key Statistics for Lung Cancer. American Cancer Society. About Lung Cancer Website. https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00.pdf. Published 2022. Accessed June 16, 2022.
- Gildea TR,
DaCosta Byfield S, Hogarth DK, Wilson DS, Quinn CC. A Retrospective Analysis of Delays in the Diagnosis of Lung Cancerand Associated Costs. Clinicoecon Outcomes Res. 2017;9:261-269.
- Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRAS (G12C) Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med 2021;384:185-7.
- Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget 2016;7:78985-93.
- Lee MJ, Hueniken K, Kuehne N, et al. Cancer Patient-Reported Preferences and Knowledge for Liquid Biopsies and Blood Biomarkers at a
Comprehensive Cancer Center. Cancer Manag Res 2020;12:1163-73.
- Sabari JK, Offin M, Stephens D, et al. A Prospective Study of Circulating Tumor DNA to Guide Matched Targeted Therapy in Lung Cancers. J Natl Cancer Inst 2019;111:575-83.