Agilent receives European IVDR certification for gastric cancer companion diagnostic

Agilent Technologies announced that its PD-L1 IHC 22C3 pharmDx assay has received IVDR certification in Europe as a companion diagnostic for identifying gastric and gastroesophageal junction (GEJ) adenocarcinoma patients eligible for treatment with KEYTRUDA (pembrolizumab). The test is approved for exclusive use with the Agilent Autostainer Link 48.

The certification expands the assay’s indication, making it the only IVDR-certified CDx test in Europe for gastric and GEJ adenocarcinoma in addition to its existing certifications for non-small cell lung cancer, urothelial carcinoma, esophageal cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, and cervical cancer.

KEYTRUDA, developed by Merck, is indicated in Europe for both HER2-positive and HER2-negative advanced gastric or GEJ adenocarcinoma patients whose tumors express PD-L1 (CPS ≥ 1), in combination with other chemotherapies.

According to Agilent, gastric cancer remains a leading cause of cancer mortality in Europe, with a five-year survival rate of 26% and over 130,000 new cases in 2022.

This regulatory milestone enhances Agilent’s position in the oncology diagnostics space and reinforces its partnership with Merck.

Agilent Board Member Heidi Kunz Announces Resignation
Santa Clara, CA – March 27, 2025 – Agilent Technologies, Inc. (NYSE: A) announced that Heidi Kunz, a member of its Board of Directors, will resign effective May 21, 2025. She also served on the Compensation Committee and the Nominating/Corporate Governance Committee.

The company stated that Ms. Kunz’s resignation was not due to any disagreement with the board or management. Agilent expressed gratitude for her service and contributions.

AGILENT’S CELL ANALYSIS TECHNOLOGY SUPPORTS FDA APPROVAL OF AUTOLUS CAR T THERAPY

Agilent Technologies has announced its role in the recent FDA approval of Autolus Therapeutics' CAR T therapy, AUCATZYL®, through the application of its xCELLigence Real-Time Cell Analysis (RTCA) technology. This advanced, label-free instrumentation provided continuous monitoring of cell behavior, supporting the development of a reliable potency assay for the therapy.

Agilent’s xCELLigence RTCA system helped ensure precision and accuracy in cell analysis, contributing to Autolus’ regulatory success. The platform measures electrical impedance to track cell viability and morphology in real time, offering significant advantages over traditional endpoint assays.

Executives from both companies, including Agilent’s VP Dr. Xiaobo Wang and Autolus’ CTO David Brochu, emphasized the importance of collaboration in achieving this milestone. Both firms are presenting their joint insights at the 2025 Hybrid US Bioassay Conference in Tucson.

This partnership highlights Agilent’s commitment to enabling innovation in cancer treatment and advancing real-time analytical tools that improve therapeutic development outcomes.

Agilent Technologies announced a change in its organizational structure to enhance its market-focused, customer-centric strategy. The company has reorganized its business into three reportable segments: Life Sciences and Diagnostics Markets, Agilent CrossLab, and Applied Markets.

The Life Sciences and Diagnostics Markets segment now includes the former Diagnostics and Genomics segment along with the liquid chromatography and liquid chromatography mass spectrometry instrument platforms. The Agilent CrossLab segment now incorporates chemistries and supplies, laboratory automation, and software and informatics divisions, which were previously part of the Life Sciences and Applied Markets segment. The remaining divisions from the former Life Sciences and Applied Markets segment, including gas chromatography, gas chromatography mass spectrometry, remarketed instruments, spectroscopy, and vacuum divisions, now form the new Applied Markets segment.

To reflect these structural changes, Agilent has recast certain sections of its Annual Report on Form 10-K for the year ended October 31, 2024, including sections on Business, Properties, Management’s Discussion and Analysis of Financial Condition and Results of Operations, and Financial Statements and Supplementary Data. However, this recast does not amend or restate the audited consolidated financial statements but serves for informational purposes only.

The company advises investors to refer to its most recent filings, including the Quarterly Report on Form 10-Q for the period ending January 31, 2025, for updated financial and operational information.