TruSight Oncology Comprehensive - P230011
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: TruSight Oncology Comprehensive
PMA Applicant: Illumina, Inc
Address: 5200 Illumina Way, San Diego, CA 92122 USA
Approval Date: August 21, 2024
Approval Letter: Approval Order
What is it?
The TruSight Oncology Comprehensive is a laboratory test that detects changes (mutations) in the DNA (517 different genes) or RNA (25 different genes) of tumor tissue samples from cancer patients who have been diagnosed with solid cancerous (malignant) tumors.
This lab test is used as a companion diagnostic to determine if certain people will benefit from treatment with a specific drug or therapy:
- People with solid malignant tumors that have specific RNA changes in the NTRK1, NTRK2, and NTRK3 genes detected by the test may benefit from personalized treatment with VITRAKVI (larotrectinib).
- People with non-small cell lung cancer who have certain RNA mutations in the RET gene may benefit from personalized treatment with RETEVMO (selpercatinib).
- A small amount of cancer tissue from a person's tumor is sent to a clinical laboratory.
The DNA and/or RNA are separated from the samples and mixed with chemical substances, called reagents, that find and test for changes in the genes.
- A medical professional reviews the results and sends a report to the doctor who ordered the test.
- The doctor uses this information to help create a treatment plan for people with solid malignant tumors or for people with non-small cell lung cancer.
The test is used to test tumor tissue from people with solid malignant tumors or non-small cell lung cancer in order to help doctors decide if that person might be eligible for treatment with larotrectinib or selpercatinib, respectively.
TruSight Oncology Comprehensive results can help doctors match people who have NTRK fusion positive solid malignant tumors or RET fusion positive non-small cell lung cancer with a drug that may be effective to treat their cancer.
There are no known reasons not to use this test.