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 KRAZATITM. 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.
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] American Cancer Society. About Lung Cancer. Accessed December 21, 2022.