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  1. Device Approvals, Denials and Clearances

PD-L1 IHC 22C3 pharmDx – P150013/S006

PD-L1 IHC 22C3 pharmDx – P150013/S006

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Image of PD-L1 IHC 22C3 pharmDx

Product Name: PD-L1 IHC 22C3 pharmDx
PMA Applicant: Dako North America, Inc.
Address: 6392 Via Real, Carpinteria, CA 93013
Approval Date: September 22, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013S006a.pdf

What is it? It is a laboratory test doctors used to identify the protein, PD-L1, in tumor tissue obtained from gastric cancer patients. This laboratory test helps doctors decide whether patient is eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).

How does it work?

  • A sample of a patient’s cancer is obtained by the doctor and sent to a clinical laboratory The lab puts the cancer sample into wax and cuts off a thin slice of it.
  • The lab treats the slice with this test. If the slice has PD-L1, it will stain dark brown.

The lab doctor (pathologist) presents the findings to the patient’s physician to help determine if patient is eligible for treatment with Keytruda.

When is it used? To help doctors decide whether patient is eligible for treatment with KEYTRUDA® (pembrolizumab). Doctors use KEYTRUDA® to treat patients who have gastric cancer.

What will it accomplish? The PD-L1 IHC 22C3 pharmDx helps select eligible patients for treatment with KEYTRUDA® based on their test result.

When should it not be used? There are no known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online: