Agilent Receives FDA Approval for Expanded Use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in Esophageal Squamous Cell Carcinoma, Triple-Negative Breast Cancer, Cervical Cancer, and Gastric or Gastroesophageal Junction Adenocarcinoma

Key Terms

pd-l1 medical

PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.

ihc medical

Immunohistochemistry (IHC) is a laboratory technique that uses labeled antibodies to detect and visually highlight specific proteins inside tissue samples, producing stained patterns pathologists can see under a microscope. For investors, IHC matters because it helps confirm whether a drug or diagnostic hits the intended target in real patient tissues and can support patient selection, clinical trial design and regulatory filings — essentially acting like a map that shows where a therapy is likely to work and reducing clinical and regulatory risk.

companion diagnostic medical

A companion diagnostic is a medical test designed to identify which patients are likely to benefit from a specific drug or medical treatment, much like a key that shows whether a particular lock will open. For investors, these tests matter because they can increase a drug’s chances of approval and market uptake, create a separate revenue stream, and reduce commercial risk by matching treatments to the patients most likely to respond.

immunotherapy medical

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

car t therapy medical

A type of cancer treatment that takes a patient’s own immune cells, reprograms them to recognize and attack tumor cells, then returns them to the body much like retraining soldiers to spot a hidden enemy. It matters to investors because these therapies can command high prices, offer long-lasting remissions for some hard-to-treat cancers, and carry manufacturing, regulatory and safety risks that can strongly affect a company’s revenue and valuation.

combined positive score (cps) medical

A combined positive score (CPS) is a single lab metric that measures how many tumor and nearby immune cells show a specific biomarker, expressed relative to the total number of tumor cells. Think of it as one gauge that blends two readings—tumor and immune cell signals—into a single percentage-like value. Investors care because CPS often determines which patients receive a drug, influences clinical-trial outcomes, regulatory labeling and market size, and therefore can affect a therapy’s commercial prospects.

tumor proportion score (tps) medical

Tumor proportion score (TPS) is the percentage of cancer cells in a tissue sample that show a specific biomarker used to predict response to certain immunotherapies. Think of it like checking what fraction of houses in a neighborhood display a particular flag — a higher fraction suggests the treatment is more likely to work for that tumor. For investors, TPS matters because it can determine which patients are eligible for a drug, influence clinical trial success, and affect the size of the potential market and regulatory decisions.

her2-positive medical

HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.

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Approval expands PD-L1 testing onto an automated workflow to support treatment decisions with KEYTRUDA^® (pembrolizumab)¹^,²

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of PD-L1 IHC 22C3 pharmDx, Code GE006, for use on the Dako Omnis platform to aid in identifying patients in the United States with esophageal squamous cell carcinoma (ESCC)³, triple-negative breast cancer (TNBC)⁴, cervical cancer⁵, and gastric or gastroesophageal junction (GEJ) adenocarcinoma⁶, who may be eligible for treatment with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy.

This approval expands access to PD-L1 testing across four additional tumor types beyond the previously approved non-small cell lung cancer (NSCLC)⁷ and head and neck squamous cell carcinoma (HNSCC)⁸. Until now, these FDA-approved PD-L1 IHC 22C3 pharmDx indications have been available on Autostainer Link 48 (ASL48) as the only platform and are now also approved for the Dako Omnis platform. This enables pathology laboratories to consolidate PD-L1 testing across more tumor types within a single automated Dako Omnis workflow, supporting increased automation and operational efficiency.

Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Pathology laboratories are increasingly looking to standardize testing on automated platforms that fit seamlessly into daily workflow. By expanding PD-L1 IHC 22C3 pharmDx on Dako Omnis for additional FDA-approved indications, we’re helping labs deliver PD-L1 results more conveniently and efficiently, supporting clinicians as they identify patients who may be eligible for immunotherapy.”

To support expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis, Agilent conducted a multisite external platform performance comparison study evaluating concordance of PD-L1 IHC 22C3 pharmDx results across staining platforms (Code SK006 on the ASL48 platform and Code GE006 on Dako Omnis) for the four additional indication specimens. Study results met acceptance criteria to demonstrate inter-platform concordance for these specimens when assessed at the appropriate CPS cutoffs.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA ^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Footnotes:

1. PD-L1 IHC 22C3 pharmDx, Code GE006 [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc.; 2026.
2. KEYTRUDA^® (pembrolizumab) Merck Sharp & Dohme LLC, Rahway, NJ, USA; 2026.
3. For the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 [Combined Positive Score (CPS)≥10] as determined by an FDA-authorized test.
4. In combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.
5. As a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test.
6. In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test.
7. As a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is:
   • Stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
8. As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
9. As a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test.

About Agilent Technologies

Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to 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 $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

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MEDIA CONTACT:
Kate Coyle
Agilent Technologies Inc.
+1 302-633-7490
kate.coyle@agilent.com

Source: Agilent Technologies Inc.