SANTA CLARA, Calif. / Jan 23, 2023 / 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 KRAS^G12C-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 subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

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.