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Oncomine Dx Target Test – P160045/S031

Oncomine Dx Target Test

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:   Oncomine Dx Target Test
PMA Applicant:  Life Technologies Corporation
Address:                 7335 Executive Way, Frederick, MD 21704
Approval Date:    September 21, 2022
Approval Letter: Approval order

What is it?

The Oncomine Dx Target Test (ODxTT) is a laboratory test designed to find variations in the genetic material of tumor tissue samples from patients with non-small cell lung cancer and cholangiocarcinoma, or bile duct cancer. This test detects changes (mutations) in the BRAF, EGFR, IDH1 and ERBB2 genes and chromosome abnormalities caused by rearrangement (translocation) in ROS1 and RET genes.

This approval expands the indications for use of the Oncomine Dx Target Test to include testing patients with non-small cell lung cancer or thyroid cancer for RET translocations and patients with medullary thyroid cancer for RET mutations. People who have cancer with these genetic changes may benefit from treatment with an FDA-approved drug, RETEVMO (selpercatinib).

How does it work?

For this test:

  • The doctor takes a small amount of cancer tissue from a patient's tumor and sends it to a lab.
  • The lab isolates DNA and RNA from the sample. These are mixed with chemical substances called reagents that find and test the DNA and RNA sequences of the patient’s RET genes.
  • The tumor’s sequenced DNA and RNA is reviewed by a trained medical professional to see if mutations or translocations are present. A report is sent to the patient’s doctor.
  • The doctor uses this information to help manage the treatment of the patient’s cancer. 

When is it used?

Doctors use the Oncomine Dx Target Test to test if a patient with non-small cell lung, medullary thyroid, or thyroid cancer may be eligible for a specific therapy to treat their cancer.

What will it accomplish?

The Oncomine Dx Target Test helps doctors identify patients with non-small cell lung, medullary thyroid, or thyroid cancer who may be eligible for treatment with RETEVMO (selpercatinib).

Identifying these mutations can help patients with these cancers receive personalized treatment targeting these genetic changes.

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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