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  1. Recently-Approved Devices

VENTANA FOLR1 (FOLR-2.1) RxDx Assay – P220006

The VENTANA FOLR1 (FOLR-2.1) RxDx Assay kit, labeling, and laboratory equipment used to process samples.

 

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 FOLR1 (FOLR-2.1) RxDx Assay
PMA Applicant:  Ventana Medical Systems, Inc.
Address:                 1910 E Innovation Park Drive, Tucson, AZ 85755 
Approval Date:    November 14, 2022
Approval Letter:  Approval order

What is it?

VENTANA FOLR1 (FOLR-2.1) RxDx Assay is a laboratory test designed to detect folate receptor alpha (FOLR1) protein in patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer. If the test shows that a patient’s cancer has the FOLR1 protein, the patient may benefit from treatment with the cancer drug ELAHERE.

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 some of the sample for this test. The sample is mixed with chemical substances, called reagents, to test for the FOLR1 protein. If the protein is present, the sample turns a dark brown color. If the sample does not have FOLR1 protein, it will not change color.
  • The results are reviewed by a trained medical professional to see if the protein is present and if it is above a certain level. A report is sent to the patient's doctor, and the doctor uses this information to help manage the care of the patient’s cancer. 

When is it used?

VENTANA FOLR1 (FOLR-2.1) RxDx Assay is used to test patients with ovarian, peritoneal, or fallopian tube cancer for the FOLR1 protein and to see if they may be eligible for a specific therapy to treat their cancer.

What will it accomplish?

Test results from the VENTANA FOLR1 (FOLR-2.1) RxDx Assay are used to help doctors to decide if patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer can receive treatment with the drug ELAHERE.

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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