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: October 15, 2021
Approval Letter: Approval Order

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.

What is it?

The VENTANA PD-L1 (SP263) Assay is a test done in a laboratory using samples from non-small cell lung cancer (NSCLC) patients which doctors use to see if patients have programmed cell death ligand (PD-L1) in their cancer.

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 laboratory treats a small slice of the tissue with the VENTANA PD-L1 (SP263) Assay. If the sample has PD-L1 protein, it stains dark brown. If the sample does not have PD-L1 protein, it will not have any staining. A 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 patients with non-small cell lung cancer.

When is it used?

The VENTANA PD-L1 (SP263) Assay is used by a doctor to decide whether a patient with non-small cell lung cancer is eligible for treatment with the drug TECENTRIQ (atezolizumab).

What will it accomplish?

It can help doctors decide if atezolizumab is the best treatment option for their patients. Patients with a positive test result from this test can benefit from the drug TECENTRIQ (atezolizumab).

When should it not be used?

There are no known reasons not to use this test.

Additional information (including warnings, precautions, and adverse events