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  1. Device Approvals, Denials and Clearances

VENTANA PD-L1 (SP142) Assay - P160002/S009

VENTANA PD-L1 (SP142) Assay - P160002/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: VENTANA PD-L1 (SP142) Assay
PMA Applicant: Ventana Medical Systems, Inc.
Address: 1910 East Innovation Park Drive, Tucson, AZ 85755
Approval Date: March 11, 2019
Approval Letter: Approval Order

What is it? It is a test done in a laboratory using samples from triple negative breast cancer patients which doctors use to see if patients have programmed cell death ligand (PD-L1) in their cancer.

When is it used? To help doctors decide whether atezolizumab is the best treatment choice for their patients. Atezolizumab is a drug that blocks PD-L1. Doctors use atezolizumab in combination with paclitaxel protein-bound to treat patients who have triple negative breast cancer and who have PD-L1 in their cancer. Previous FDA approvals for this product are for use in bladder cancer and non-small cell lung cancer patients. In this PMA supplement (009), FDA approved this product to be used in testing triple negative breast cancer patients.

How does it work?

  • A doctor sends a small piece of cancer taken from a biopsy from the patient to a lab.
  • The lab puts the piece 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) looks at the slice.
  • The lab tells the patient's doctor if PD-L1 is present in the slice.
  • The doctor uses this information to help manage patient care.

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 atezolizumab.

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

Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available at: