Agilent Receives EU Approval for PD-L1 IHC 22C3 pharmDx in Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Key Terms

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.

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.

anti-pd-1 therapy medical

Anti-PD-1 therapy are drugs that block the PD-1 protein on immune cells, effectively releasing the “brakes” that can prevent the body from attacking cancer cells; think of it like removing a safety lock so security guards can better recognize intruders. Investors care because these therapies can transform treatment outcomes, drive significant sales if approved for multiple cancers, and carry regulatory, patent and competitive risks that affect a company’s valuation.

platinum-resistant setting medical

A clinical situation in oncology where a patient’s tumor no longer responds to platinum-based chemotherapy drugs, usually because the cancer returned or progressed within a defined short time after treatment. It matters to investors because drugs labeled for a platinum-resistant setting target a distinct and often unmet medical need, affecting the size of the eligible patient population, trial design and endpoints, regulatory pathways, and commercial opportunity—similar to developing a new tool when the usual one no longer works.

ce-marked regulatory

CE-marked indicates a product meets European Union requirements for safety, performance and legal compliance, allowing it to be sold across the European Economic Area. For investors, a CE mark is like a passport or safety stamp — it reduces regulatory and market-entry risk, can speed sales and adoption across many countries, and signals the maker completed required testing and documentation, which can affect revenue forecasts and valuation.

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Approval expands PD-L1 testing to support treatment decisions with KEYTRUDA^® (pembrolizumab)

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced it has received European Union (EU) certification for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA^® (pembrolizumab), Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy.

PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with pembrolizumab, in accordance with the approved product labelling, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the eighth CE-marked companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006 in the EU.

“Expanding access to precision oncology across regions is essential to improving patient outcomes,” said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division. “This EU approval builds on our commitment to deliver high-quality companion diagnostics and enables laboratories to support more informed treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.”

PD-L1 expression in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96/ENGOT -ov65 clinical trial, supporting its use as an aid in identifying patients who may be eligible for treatment with pembrolizumab in the platinum-resistant setting.

In addition, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the EU to help physicians identify patients across several tumor types, including non-small cell lung cancer (NSCLC), esophageal cancer, cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or gastroesophageal junction (GEJ) adenocarcinoma and urothelial carcinoma, who may be eligible for treatment with KEYTRUDA^®, in accordance with the approved product labelling.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside of 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

See the KEYTRUDA^® product label for specific clinical circumstances guiding therapy

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.