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: CRCdx® RAS Mutation Detection Kit
PMA Applicant: EntroGen, Inc.
Address: 20950 Warner Center Ln, Woodland Hills, CA 91367
Approval Date: September 29, 2023
Approval Letter: Approval Order
What is it?
The CRCdx® RAS Mutation Detection Kit is a laboratory test designed to detect changes in the genetic material in tumor tissue samples from a person with colorectal cancer. The results help doctors determine if a person is a good candidate for treatment with the drug, panitumumab. The drug is also known by its brand name, Vectibix.
The test detects certain mutations in RAS genes in tumor samples from a person with colorectal cancer. If the test finds a mutation in the colorectal cancer tissue, then panitumumab is not recommended. If the test does not detect a mutation, then panitumumab may be an appropriate treatment.
How does it work?
The doctor takes a small amount of cancer tissue from a person’s tumor and sends it to a lab. The lab embeds the cancer tissue into wax, which is later cut into thin slices. The lab uses a few slices to isolate DNA, which is later mixed with chemicals called reagents that specifically find and test the DNA for changes in certain genes. The lab sends the results to the doctor who ordered the test. The person’s doctor uses this information to help manage medical care for the previously diagnosed colorectal cancer.
When is it used?
The test is used to evaluate tumors of a person with colorectal cancer. The results help doctors decide if a person might be eligible for treatment with panitumumab.
What will it accomplish?
Test results are used to help doctors match a person who has colorectal cancer with an appropriate drug to treat their disease.
When should it not be used?
There are no known reasons not to use this test.
Additional information (including warnings, precautions, and adverse events):
- Safety and Effectiveness Data