VENTANA MMR RxDx Panel – P210001
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 labelingfor more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: VENTANA MMR RxDx Panel
PMA Applicant: Ventana Medical Systems, Inc.
Address: 1910 East Innovation Park Drive, Tucson, AZ 85755
Approval Date: August 17, 2021
Approval Letter: Approval Order
What is it?
The VENTANA MMR RxDx Panel is a laboratory test designed to detect mismatch repair (MMR) proteins (MSH6, PMS2, MSH2 and MLH1) in patients diagnosed with solid tumors that have reoccurred multiple times (recurrent) or those who have advanced solid tumor growth. If the MMR proteins are not present, it indicates a patient with recurring or advanced solid tumors is eligible for treatment with JEMPERLI (dostarlimab‐gxly).
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 MMR RxDx test. If the sample has MMR proteins, it stains dark brown. If the sample does not have MMR proteins, 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 recurring or advanced solid tumors.
When is it used?
The VENTANA MMR RxDx Panel is used by a doctor to decide whether a patient with recurring or advanced solid tumor is eligible for treatment with the drug JEMPERLI (dostarlimab‐gxly).
What will it accomplish?
Test results from the VENTANA MMR RxDx Panel are used to help doctors determine if patients with recurrent or advanced solid tumors are eligible for treatment with JEMPERLI (dostarlimab‐gxly).
When should it not be used?
There are no known reasons not to use this test.