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VENTANA PD-L1 (SP263) Assay – P160046/S013

VENTANA PD-L1 (SP263) Assay


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: VENTANA PD-L1 (SP263) Assay
PMA Applicant: Ventana Medical Systems, Inc.
Address: 1910 East Innovation Park Drive, Tucson, AZ 85755
Approval Date: March 1, 2023
Approval Letter: Approval Order

What is it?

The VENTANA PD-L1 (SP263) Assay is a laboratory test designed to detect PD-L1 protein in people diagnosed with non-small cell lung cancer. If the PD-L1 protein is present, it indicates that the patient may benefit from treatment with the cancer drug LIBTAYO (cemiplimab-rwlc).

How does it work?

  • The doctor takes a small sample of tumor tissue from the patient and sends it to a laboratory for testing. 
  • The lab treats a small slice of the tissue with chemical substances, called reagents, to test for the PD-L1 protein. If the protein is present, the sample turns a dark brown color. If the sample does not have PD-L1 protein, it will not change color. 
  • A trained medical professional reviews the results and sends a report to the patient’s doctor. 
  • The doctor uses this information to help manage the care of patient’s non-small cell lung cancer.  

When is it used?

The VENTANA PD-L1 (SP263) Assay is used to test for the PD-L1 protein in people with non-small cell lung cancer to help  determine if they are eligible for a specific therapy to treat their cancer.

What will it accomplish?

Test results from the VENTANA PD-L1 (SP263) Assay are used to help doctors decide if patients with non-small cell lung cancer can receive treatment with the drug LIBTAYO (cemiplimab-rwlc).

When should it not be used?

There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events):

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