The agreement between Quest and Agilent will enable widespread adoption of ctDx FIRST, a pre-marketed single site test (ssPMA) performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington. ctDx FIRST is the first liquid biopsy test approved by the US Food and Drug Administration (FDA) as an adjunct diagnostic (CDx) to identify patients with advanced non-small cell lung cancer (NSCLC) who may benefit from treatment with KRAZATI™. KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C– locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, which has received at least one prior systemic therapy. ctDx FIRST is also FDA-approved for epidermal growth factor receptor (EGFR) gene tumor profiling in accordance with professional oncology guidelines for patients with advanced non-small cell lung cancer (NSCLC).
As a professional service, the ctDx FIRST* test report includes comprehensive genomic profiles on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications and fusions.
“We look forward to the Quest Diagnostics alliance to facilitate widespread access to ctDx FIRST, our liquid biopsy solution,” said Paul Beresford, vice president and general manager, Complementary Diagnostics at Agilent. “This expands the testing options available to patients with NSCLC, as patients don’t always have tissue available for molecular analysis.”
“The addition of the ctDx FIRST test to our oncology menu reinforces our commitment to providing access to precision medicine innovations to improve care for cancer patients,” said Kristie Dolan, vice president and general manager, oncology franchise, Quest Diagnostics. “It also reflects our ability to leverage our national physician and patient access network to broaden access to important medical innovations with the potential to improve patient outcomes.”
Under the terms of the agreement, Quest will offer the ctDx FIRST to healthcare professionals in the United States who are looking for a minimally invasive liquid biopsy test option like a CDx for KRAZATI. Healthcare professionals can order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records (EMRs). Healthcare professionals can direct patients to provide specimens at one of Quest’s 2,100 patient care centers across the United States. Integrating Quest’s electronic health record (EHR) platform and access to its national network of patient centers will make it easier for healthcare professionals to incorporate ctDx FIRST as part of regular clinical care.
Agilent and Quest have previously collaborated on the Ki-67 IHC MIB-1 pharmDx and PD-L1.
* CLIA validated, not FDA approved
There are two main types of lung cancer, non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). First named for the appearance of the cancer cells under the microscope, these two represent 230,000 newly diagnosed cases of lung cancer in the US each year. The vast majority (85 percent) of lung cancers fall into the non-small cell lung cancer category. Although this form of lung cancer progresses more slowly than SCLC, 40% of NSCLCs will have spread beyond the lungs by the time they are diagnosed.I
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics and applied chemicals markets, delivering insights and innovations that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services and expertise that provide reliable 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, sign up for the Agilent press room. Follow Agilent on LinkedIn and Facebook.
IMPORTANT SAFETY AND USE INFORMATION
What is KRAZATI?
KRAZATI is a prescription drug 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 previous treatment for cancer.
Your doctor will test you to make sure that KRAZATI is suitable for you.
It is not known whether KRAZATI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What should I tell my doctor before taking KRAZATI?
Before taking KRAZATI, tell your doctor about all of your medical conditions, including if you:
have any heart problems, including heart failure and congenital long QT syndrome,
have liver problems,
are pregnant or planning to become pregnant. It is not known whether KRAZATI can harm an unborn baby,
are breastfeeding or plan to breastfeed. It is not known whether KRAZATI passes into breast milk. Do not breast-feed during treatment and for 1 week after the last dose of KRAZATI
Tell your doctor about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements. KRAZATI can affect how 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 sometimes be serious as well. KRAZATI can also cause serious stomach and intestinal side effects such as bleeding, obstruction, colon inflammation (colitis) and narrowing (stricture).
Contact your doctor if you develop any of the signs or symptoms of stomach or intestinal problems listed above while taking KRAZATI.
Your doctor may prescribe an anti-diarrheal or anti-nausea medication 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). Prolonging the QTc interval can increase the risk of life-threatening irregular heartbeats, 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 doctor about all of your medical conditions, including if you:”
Your doctor should monitor your heart’s electrical activity and 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 are taking a medication that may prolong the QT interval of your heartbeat.
Tell your doctor if you feel dizzy, lightheaded or faint, or if you have an abnormal heartbeat while taking KRAZATI.
Liver problems. Abnormal liver blood test results are common with KRAZATI and can sometimes be serious. Your doctor should do blood tests before starting and during treatment with KRAZATI to check your liver function. Tell your doctor right away if you develop any signs or symptoms of liver problems, including:
Your skin or the whites of your eyes turn 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, soreness, or tenderness on the right side of your stomach area (abdomen).
Lung or breathing problems. KRAZATI can cause inflammation of the lungs which can lead to death. Tell your doctor 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 problems, decreased appetite.
Certain abnormal laboratory test results are common with KRAZATI. Your doctor will monitor you for abnormal lab tests and treat you if necessary.
KRAZATI can cause fertility problems in both men and women, which may affect your ability to have children. Talk to your doctor if this is a concern for you.
These are not all possible side effects of KRAZATI. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
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.