Oncomine Dx Target Test – P160045/S046

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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: 7305 Executive Way, Frederick, MD 21704
Approval Date: October 17, 2024
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 someone with a specific type of cancer.

This approval expands the use of the Oncomine Dx Target Test to identify a mutation in astrocytoma and oligodendroglioma brain tumors. People whose astrocytoma and oligodendroglioma brain tumors have this specific change (specifically, IDH1 and IDH2 mutations) detected by the test may benefit from personalized treatment with VORANIGO (vorasidenib).

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, medullary thyroid cancer and anaplastic thyroid cancer.

How does it work?

The doctor takes a small sample of cancer tissue from a 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 IDH1 and IDH2 genes 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 the treatment of a person with astrocytoma and oligodendroglioma. The presence of IDH1 and IDH2 mutations in the tumor tissue sample indicates a person may benefit from personalized treatment with VORANIGO (vorasidenib).

When is it used?

The test is used to evaluate tumors from people with astrocytoma and oligodendroglioma. The results help doctors decide if a person might be eligible for treatment with VORANIGO (vorasidenib).

What will it accomplish?

The Oncomine Dx Target Test can help doctors decide whether people with astrocytoma and oligodendroglioma can receive treatment with VORANIGO (vorasidenib) based on their test results.

Additional information (warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling - User Guide

• PMA Database Entry