FDA approves Keytruda companion diagnostic

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has approved PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with Keytruda on the Dako Omnis platform.

Agilent Technologies Inc. sponsors PD-L1 IHC 22C3 pharmDx. Dako Omnis is Agilent’s fully automated, walk-away solution for staining tumor samples that provides a flexible, high-throughput diagnostic service integrated into the core of the laboratory workflow.

Table of Contents

YOU MAY BE INTERESTED IN

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it.  To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease.  The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login