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: THxID™ BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument
PMA Applicant: bioMérieux Inc.
Address: Mailing 595 Anglum Rd., Hazelwood, MO 63042
Approval Date: May 29, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/p120014a.pdf
What is it? The THxID™ BRAF Kit is an automated molecular assay designed to detect the presence of mutations in the BRAF gene in the most serious type of skin cancer (melanoma). In normal skin tissue, the B-raf helps control cell growth and cell death. In melanoma, mutations referred to as BRAF V600E and V600K cause an altered form of the B-raf protein. This results in abnormal functioning of the protein and stimulates melanoma growth.
Mekinist™ (tramatenib) and Tafinlar® (dabrafenib) are drugs used to treat patients with advanced (metastatic) melanoma, which has spread in the body, or melanoma that cannot be removed by surgery (unresectable). The drugs block the mutant version of B-raf. This test is used to determine a patient’s eligibility for treatment with Mekinist™ or Tafinlar®. If the test result indicates that a V600E or V600K mutation is present in the melanoma cells, then the patient may receive treatment with Mekinist™ or Tafinlar®.
How does it work? The doctor takes a small amount of tissue sample from the patient’s melanoma and examines it (biopsy). The tissue is embedded in a block of paraffin wax and a thin slice is cut from the block for use in the test. DNA is isolated from the patient’s cancer cells and is mixed with reagents that specifically detect and measure the presence or absence of the mutation in the cancer sample. The presence of the V600E mutation in the BRAF gene indicates that a patient is eligible for melanoma treatment with Tafinlar®. The presence of the V600E or V600K mutation in the BRAF gene indicates that a patient is eligible for melanoma treatment with Mekinist™.
When is it used? To determine if a patient’s melanoma characteristics suggest that they might be a candidate for Mekinist® or Tafinlar® therapy.
What will it accomplish? The THxID™ BRAF Kit helps to determine the eligibility of patients with melanoma for Mekinist™ or Tafinlar® treatment, which may prolong their life.
When should it not be used? There are no known contraindications for the test.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.