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 29, 2023

Approval Letter: Approval Order

What is it?

The Oncomine™ Dx Target Test is a laboratory test designed to detect genetic changes in tumor tissue samples from a person with certain type of cancers. This approval expands the use of the test to identify a certain mutation in anaplastic thyroid cancer. People whose anaplastic thyroid cancer has a certain change (specifically BRAF V600E mutation), detected by the test may benefit from personalized treatment with TAFINLAR® in combination with MEKINIST®.

The test was previously approved to detect certain genetic changes in tissue samples from people with non-small cell lung cancer, cholangiocarcinoma (bile duct cancer), thyroid cancer, and medullary thyroid cancer.

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 and RNA, which are later mixed with chemicals called reagents that detect and analyze specific DNA sequences of the BRAF gene to evaluate the presence or absence of a mutation. The lab sends the results to the doctor who ordered the test. The doctor uses this information to help manage treatment for a person with anaplastic thyroid cancer. If the BRAF mutation is found in the cancer tissue sample, it indicates that this particular person is eligible for treatment with TAFINLAR® in combination with MEKINIST ®.

When is it used?

The test is used to evaluate tumors from people with anaplastic thyroid cancer. The results help doctors decide if a person might be eligible for treatment with TAFINLAR® (dabrafenib) in combination with MEKINIST (trametinib).

What will it accomplish?

The Oncomine™ Dx Target Test can help doctors decide whether people with anaplastic thyroid cancer can receive treatment with TAFINLAR® (dabrafenib) in combination with MEKINIST (trametinib) based on their test results.

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