Product Name: Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
PMA Applicant: Agilent Technologies, Inc.
Address: 5301 Stevens Creek Boulevard, Santa Clara, CA 95051
Approval Date: October 12, 2021
Approval Letter: Approval Letter
What is it? The Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a laboratory test designed to identify if a patient with early breast cancer (EBC) has the protein called Ki-67 in their cancer. The laboratory test is a companion diagnostic that can help doctors identify if patients with early breast cancer have the protein Ki-67 may benefit from treatment with the drug abemaciclib combined with standard additional endocrine therapy.
How does it work? The doctor collects a small sample of tissue from the patient's tumor and sends it to a lab. The lab uses a portion of the sample to administer the test. If the sample has the protein Ki-67, it will turn dark brown. If the sample does not have the Ki-67 protein, it will not change color.
Once the test is complete, a report is sent to the patient's doctor informing them if the level of the Ki-67 is above a certain threshold.
When is it used? The Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is used to help doctors decide if a patient with early breast cancer is eligible for a specific therapy to treat their cancer.
What will it accomplish? Test results from the Ki-67 IHC MIB-1 pharmDx (Dako Omnis) are used to help doctors decide if patients with early breast cancer can receive treatment with the drug abemaciclib combined with standard additional endocrine therapy.
When should it not be used? There are no known reasons not to use this test.
Additional information (including warnings, precautions and adverse events):