Quest Diagnostics, provider of diagnostic information services, this week introduced a new cancer test service based on the FDA-approved THxID-BRAF test from in vitro diagnostics provider bioMérieux. The THxID-BRAF test is a companion diagnostic for two treatments for melanoma. It is intended to be used as an aid in selecting patients with melanoma whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist]. BRAF is a gene implicated in several cancers, including melanoma. Approximately half of melanomas arising in the skin have a BRAF gene mutation.
The U.S. Food and Drug Administration (FDA) approved the two drugs and the gene test as a companion diagnostic in May 2013. The drugs treat patients with advanced (metastatic) or unresectable (cannot be surgically removed) melanoma. Pathologists may order the test through Quest Diagnostics, including its Ameripath and Dermpath businesses, which specialize in anatomic and dermatologic pathology testing.
In addition to the bioMerieux test, Quest offers the FDA-cleared cobas 4800 BRAF V600 Mutation Test, which detects the BRAF V600E mutation in order to help physicians select patients for treatment with vemurafenib, an oral medicine designed to treat patients whose melanoma tumors harbor the mutation. Quest also offers a laboratory-developed test for assessing BRAF mutations in melanoma, thyroid, and colorectal cancers based on Sanger sequencing. Learn more about professional lab services offered by Quest.Read more