When a patient is diagnosed with advanced or aggressive cancer, every single day counts. Doctors need to know immediately which treatments will work best for that specific patient's tumor.
On June 3, 2026, the U.S. Food and Drug Administration (FDA) handed oncology teams a major win by clearing an expanded, automated diagnostic test called the PD-L1 IHC 22C3 pharmDx on the Dako Omnis platform. Developed by Agilent Technologies, this advanced piece of lab equipment can now automatically screen four additional types of solid cancer tumors.
By automating what used to be a slower, multi-step lab process, this milestone helps pathologists deliver faster, highly precise data. This data is crucial because it tells doctors whether a patient is a prime candidate for a game-changing immunotherapy drug called Keytruda® (pembrolizumab).
The FDA's new clearance specifically opens doors for patients facing advanced, recurrent, or spreading (metastatic) forms of the following four cancers:
To understand why this automated test matters, it helps to understand how cancer plays hide-and-seek with your body's immune system.
Your immune system relies on special cells called T-cells to patrol your body, hunting down and destroying foreign invaders or sick cells. Healthy cells carry a protein on their surface called PD-L1. Think of PD-L1 as a biological "ID card" or a stop sign that tells the immune system, "I'm a friendly cell, do not attack me."
The Cancer Camouflage: Cancer cells are incredibly sneaky. They often grow massive amounts of the PD-L1 protein on their own surfaces. By flashing this fake "ID card," the tumor tricks the immune system into ignoring it, allowing the cancer to grow unchecked.
Immunotherapy drugs like Keytruda work by knocking that fake ID card out of the cancer cell's hand. It blocks the camouflage, allowing the patient's own immune system to recognize the cancer and attack it.
However, Keytruda only works well if the patient's tumor actually expresses a significant amount of PD-L1. That is where the newly cleared PD-L1 22C3 diagnostic test comes in: it measures exactly how much PD-L1 is present so doctors don't waste time on a treatment that won't work.
Before this expansion, pathology labs had to use a split system. They could use the fast, fully automated Dako Omnis machine to test for lung cancer and head and neck cancers. But if a patient had breast, cervical, stomach, or esophageal cancer, the lab technicians had to move those tissue samples to a separate, older, and lower-throughput machine that required more hands-on preparation.
By moving all four of these additional cancers onto the automated Dako Omnis platform, the healthcare system experiences three massive benefits:
Medical advancement isn't just about designing a new drug; it is also about building the smart, automated technology required to get that drug to the right patient, at the right dosage, without an hour of wasted time.