Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer
December 12 2022 - 8:50PM
Business Wire
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 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 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."
To learn more about the test and order visit
http://www.agilent.com/genomics/ctDxFIRST
* CLIA validated, not FDA approved
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the
life sciences, diagnostics, and applied chemical markets,
delivering insight and innovation that advance the quality of life.
Agilent’s full range of solutions includes instruments, software,
services, and expertise that provide trusted answers to our
customers' most challenging questions. The company generated
revenue of $6.85 billion in fiscal 2022 and employs 18,000 people
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References:
- 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.
- 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.
- 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.
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Naomi Goumillout Agilent Technologies +1.781.266.2819
naomi.goumillout@agilent.com
Agilent Technologies (NYSE:A)
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