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  1. Recently-Approved Devices

Oncomine Dx Target Test – P160045/S028

Picture of Oncomine Dx Target Test materials and the laboratory equipment that processes the results

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: 5781 Van Allen Way, Carlsbad, CA 92008
Approval Date: August 25, 2021
Approval Letter: Approval Order

What is it?

The Oncomine Dx Target Test is a laboratory test designed to detect the presence of mutations within a specific gene in patients who have cancer. This test helps doctors identify patients with cholangiocarcinoma who may benefit from specific FDA-approved treatments.

This approval expands the indications for use of the Oncomine Dx Target Test to include the detection of mutations to IDH1 in patients with cholangiocarcinoma (bile duct cancer). Identifying these mutations will help patients with cholangiocarcinoma patients to get personalized treatment with TIBSOVO (ivosidenib).

How does it work?

The doctor takes a small sample of tumor tissue from patients with cholangiocarcinoma and sends it to a laboratory. In the laboratory, DNA and RNA are isolated from the sample and mixed with chemical substances, called reagents, that find and test for mutations in the IDH1 gene. A medical professional then reviews the results and sends a report to the patient’s doctor. The doctor uses this information to help manage the care of patients with cholangiocarcinoma.

When is it used?

The Oncomine Dx Target Test is used to test the tumors of patients with bile duct cancer.

What will it accomplish?

Test results from the Oncomine Dx Target Test are used to help doctors decide if patients with bile duct cancer can receive treatment with TIBSOVO (ivosidenib).

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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