Agilent to Collaborate with Quest Diagnostics to Extend Access to the Agilent Resolution ctDx FIRST Liquid Biopsy Test
January 23 2023 - 8:00AM
Business Wire
Agilent Technologies Inc. (NYSE: A) today announced an agreement
with Quest Diagnostics (NYSE: DGX), the world’s leading provider of
diagnostic information services. The alliance will enable providers
and patients throughout the United States to access the Agilent
Resolution ctDx FIRST liquid biopsy next-generation sequencing
(NGS) test. Healthcare providers can order the test beginning
today.
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™. KRAZATI (adagrasib) received accelerated approval as a
targeted treatment option for adult patients with KRASG12C-mutated
locally advanced or metastatic non-small cell lung cancer (NSCLC),
as determined by an FDA-approved test, who have received at least
one prior systemic therapy. ctDx FIRST is also FDA-approved for
tumor profiling of the epidermal growth factor receptor (EGFR) gene
in accordance with professional guidelines in oncology for patients
with advanced non-small cell lung cancer (NSCLC).
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.
“We are looking forward to the Quest Diagnostics alliance
facilitating broad access to ctDx FIRST, our liquid biopsy
solution,” said Paul Beresford, vice president and general manager
of Agilent’s Companion Diagnostics Division. “This expands the
testing options available for NSCLC patients as patients don’t
always have tissue available for molecular analysis.”
"The addition of the ctDx FIRST test to our oncology menu
underscores our commitment to providing access to precision
medicine innovations to improve care for patients with cancer,"
said Kristie Dolan, vice president and general manager, Oncology
Franchise, at Quest Diagnostics. "It also reflects our ability to
optimize our national physician and patient access network to
extend access to important medical innovations with the potential
to improve patient outcomes."
Under the terms of the agreement, Quest will offer ctDx FIRST to
healthcare providers in the United States seeking a minimally
invasive liquid biopsy test option as a CDx for KRAZATI. Healthcare
providers can order the test electronically through the Quest
connectivity platform, which connects to hundreds of electronic
medical records (EMRs). Healthcare providers may direct patients to
provide specimens at one of Quest’s 2,100 patient service centers
across the United States. Integrating Quest’s electronic health
record (EHR) platform and access to its national patient center
network will make it easier for healthcare providers to incorporate
ctDx FIRST as part of regular clinical care.
Agilent and Quest have previously collaborated on Ki-67 IHC
MIB-1 pharmDx and PD-L1.
* CLIA validated, not FDA approved
About NSCLC
There are two primary types of lung cancer, non-small cell lung
cancer (NSCLC) and small cell lung cancer (SCLC). Named initially
for how the cancer cells look under the microscope, these two
account for 230,000 newly diagnosed cases of lung cancer in the
U.S. each year. The vast majority (85 percent) of lung cancers fall
into the non-small cell lung cancer category. Though this form of
lung cancer progresses more slowly than SCLC, 40 percent of NSCLCs
will have spread beyond the lungs by the time it is diagnosed.i
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
worldwide. Information about Agilent is available at
www.agilent.com. To receive the latest Agilent news, please
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USE AND IMPORTANT SAFETY INFORMATION
What is KRAZATI?
KRAZATI is a prescription medicine used to treat adults with
non-small cell lung cancer (NSCLC):
- that has spread to other parts of the body or cannot be removed
by surgery, and
- whose tumor has an abnormal KRAS G12C gene, and
- who have received at least one prior treatment for their
cancer.
Your healthcare provider will perform a test to make sure that
KRAZATI is right for you.
It is not known if KRAZATI is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking
KRAZATI?
Before taking KRAZATI, tell your healthcare provider about all
your medical conditions, including if you:
- have any heart problems, including heart failure and congenital
long QT syndrome,
- have liver problems,
- are pregnant or plan to become pregnant. It is not known if
KRAZATI can harm your unborn baby,
- are breastfeeding or plan to breastfeed. It is not known if
KRAZATI passes into your breastmilk. Do not breast feed during
treatment and for 1 week after your last dose of KRAZATI
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. KRAZATI can affect the way other medicines
work, and other medicines can affect how KRAZATI works.
KRAZATI can cause serious side effects, including:
- Stomach and intestinal (gastrointestinal) problems. Stomach and
intestinal side effects, including nausea, diarrhea, or vomiting,
are common with KRAZATI but can also sometimes be severe. KRAZATI
can also cause serious stomach and intestinal side effects such as
bleeding, obstruction, inflammation of the colon (colitis), and
narrowing (stenosis).
- Call your healthcare provider if you develop any of the signs
or symptoms of stomach or intestinal problems listed above during
treatment with KRAZATI.
- Your healthcare provider may prescribe an antidiarrheal
medicine or anti-nausea medicine, or other treatment, as
needed.
- Changes in the electrical activity of your heart (called QTc
prolongation). Certain changes can occur in the electrical activity
of your heart during treatment with KRAZATI and can be seen on a
test called an electrocardiogram (ECG or EKG). QTc prolongation can
increase your risk for irregular heartbeats that can be
life-threatening, such as torsades de pointes, and can lead to
sudden death.
- You should not take KRAZATI if you have congenital long QT
syndrome or if you currently have QTc prolongation. See “Before
taking KRAZATI, tell your healthcare provider about all of your
medical conditions, including if you:”
- Your healthcare provider should monitor the electrical activity
of your heart and the levels of body salts in your blood
(electrolytes) during treatment with KRAZATI if you have heart
failure, a slow heart rate, abnormal levels of electrolytes in your
blood, or if you take a medicine that can prolong the QT interval
of your heartbeat.
- Tell your healthcare provider if you feel dizzy, lightheaded,
or faint, or if you get abnormal heartbeats during treatment with
KRAZATI.
- Liver problems. Abnormal liver blood test results are common
with KRAZATI and can sometimes be severe. Your healthcare provider
should do blood tests before starting and during treatment with
KRAZATI to check your liver function. Tell your healthcare provider
right away if you develop any signs or symptoms of liver problems,
including:
- Your skin or white part of your eyes turns yellow (jaundice),
dark or “tea-colored urine,” light-colored stools (bowel
movements), tiredness or weakness, nausea or vomiting, bleeding or
bruising, loss of appetite, pain, aching or tenderness on the right
side of your stomach area (abdomen).
- Lung or breathing problems. KRAZATI may cause inflammation of
the lungs that can lead to death. Tell your healthcare provider or
get emergency medical help right away if you have new or worsening
shortness of breath, cough, or fever.
The most common side effects:
- The most common side effects are nausea, diarrhea, vomiting,
tiredness, muscle and bone pain, kidney problems, swelling,
breathing trouble, decreased appetite.
- Certain abnormal laboratory test results are common with
KRAZATI. Your healthcare provider will monitor you for abnormal
laboratory tests and treat you if needed.
KRAZATI may cause fertility problems in males and females, which
may affect your ability to have children. Talk to your healthcare
provider if this is a concern for you.
These are not all the possible side effects of KRAZATI. Call
your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088.
Please see KRAZATI Patient Information.
i American Cancer Society. About Lung Cancer.
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Accessed December 21, 2022.
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Naomi Goumillout Agilent Technologies +1 978 314 1862
naomi.goumillout@agilent.com
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