U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. Recently-Approved Devices
  6. PD-L1 IHC 22C3 pharmDx - P150013/S009
  1. Device Approvals, Denials and Clearances

PD-L1 IHC 22C3 pharmDx - P150013/S009

PD-L1 IHC 22C3 pharmDx - P150013/S009

Image of the device.

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.

Product Name: PD-L1 IHC 22C3 pharmDx
PMA Applicant: Dako North America, Inc.
Address: 6392 Via Real, Carpinteria, CA 93013
Approval Date: June 12, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150013S009a.pdf

What is it? PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients with lung and gastric cancer. This supplement expands the indications for use for this test to include determining whether patients with cervical cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab).

How does it work?

  • A doctor obtains a small piece of cancerous tissue from the patient's tumor and sends it to a lab.
  • At the lab, the tissue sample is put into wax and a thin slice is cut off and treated with this test. If the tumor cells in the slice have PD-L1, the test solution will react with the slice and stain the slice dark brown.

The lab clinician (pathologist) evaluates the slice under the microscope and informs the doctor if PD-L1 is present.

When is it used? PD-L1 IHC 22C3 pharmDx can be used by doctors to help decide whether a patient is eligible for treatment with KEYTRUDA® (pembrolizumab). Doctors use KEYTRUDA® to treat patients who have lung, gastric, or cervical cancer.

What will it accomplish? The PD-L1 IHC 22C3 pharmDx helps identify patients with lung, gastric or cervical cancer who are eligible for treatment with KEYTRUDA®.

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.