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  1. Recently-Approved Devices

Oncomine Dx Target Test – P160045/S029

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 15, 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 non-small cell lung cancer (NSCLC) and 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 EGFR exon 20 insertion mutations in patients with NSCLC. Identifying EGFR exon 20 insertion mutations will help NSCLC patients to get personalized treatment with EXKIVITY (mobocertinib).

How does it work?

The doctor takes a small amount of tumor tissue from the NSCLC patient and sends it to a lab. In the lab, DNA and RNA are isolated from the sample and mixed with chemical substances, called reagents, that find and test for EGFR exon 20 insertion mutations within DNA. A trained medical professional reviews the results, and then a report is sent back to the patient’s doctor. The doctor uses this information to help manage the care of patients with NSCLC.

When is it used?

The Oncomine Dx Target Test is used to test the tumors of patients with NSCLC.

What will it accomplish?

The test results from the Oncomine Dx Target Test are used to help doctors decide if patients with NSCLC can receive treatment with EXKIVITY (mobocertinib).

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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