Agilent Technologies Inc. (NYSE: A) announced today that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATITM (adagrasib).

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 healthcare 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 U.S. and is the leading cause of cancer mortality, comprising 25% of all cancer-related deaths.1 Most patients with NSCLC are diagnosed at later disease stages due to undetected early symptoms.2  Approximately 14% of NSCLC patients harbor a KRAS G12C mutation, and approximately 32% of NSCLC patients have a mutation within their EGFR gene, making this new test an attractive solution to inform treatment decisions for these patients. 3,4  ctDx FIRST provides NSCLC patients and their oncologists with a new minimally invasive blood test to help clarify precision treatment options.

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 Kenna Anderes, Mirati's Vice President of Translational Medicine and Companion Diagnostics. "We appreciate the opportunity to partner with companies like Agilent who are committed to creating more opportunities for 'decision medicine' for people living with cancer."

"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 Alan Sandler, M.D., Mirati's Chief Medical Officer. "At Mirati, we are focused on creating meaningful impacts on the lives of people with cancer. Tests like ctDx FIRST are important to realizing our commitment to patients."

"Commercializing the ctDx FIRST test enables us to support clinicians to positively impact the lives of patients with advanced NSCLC," said Sam Raha, Agilent's President of the Diagnostics and Genomics Group. "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."

* CLIA-validated, not FDA approved 

References

  1. American Cancer Society. Key Statistics for Lung Cancer. American Cancer Society. About Lung Cancer Web site. https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00.pdf. Published 2022. Accessed June 16, 2022.
  2. Gildea TR, DaCosta Byfield S, Hogarth DK, Wilson DS, Quinn CC. A Retrospective Analysis of Delays in the Diagnosis of Lung Cancer and Associated Costs. Clinicoecon Outcomes Res. 2017;9:261-269.
  3. 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.
  4. 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.
  5. 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.
  6. 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.