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: September 4, 2020
Approval Letter: Link to Approval Order

What is it?

The Oncomine™ Dx Target Test is a lab test designed to detect several specific genetic changes in tumors found in patients with non-small cell lung cancer and determine if certain medications may help treat the cancer.  It is a type of lab test called a companion diagnostic.

The test identifies DNA changes, or mutations, in two genes, the BRAF and EGFR genes, and the rearrangement, or translocation, of chromosomes in two additional genes, ROS1 and RET using ribonucleic acid (RNA), a chemical cousin of DNA.These specific gene changes, when present, are known to stimulate tumor growth. 

This supplement expands the indications for using this test to include the detection of chromosome rearrangements, or translocations, in the gene RET.

How does it work? 

The doctor takes a small amount of tumor tissue from the patient and sends it to a lab. At the lab, DNA and RNA are isolated from the patient's tumor cells and mixed with chemical substances called reagents that detect and analyze the DNA of the tumor's BRAF and EGFR genes and the RNA of the ROS1 and RET genes. 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 non-small cell lung cancer patients.

When is it used? 

Doctors use the results from the Oncomine™ Dx Target Test to decide if a patient with non-small cell lung cancer might be eligible for treatment with the following medications:

• TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib) for patients with a BRAF (V600E) mutation
• IRESSA® (gefitinib) for patients EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations)
• XALKORI® (crizotinib) for patients with ROS1 translocations
• GAVRETO™ (pralsetinib) for patients with RET translocations

What will it accomplish?

Using these test results can help doctors choose medications that better target the patient’s specific cancer.

When should it not be used? 

There are no known reasons not to use this test.

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

• Summary of Safety and Effectiveness
• Physician Labeling
• PMA Database Entry