Quest Diagnostics has introduced a test intended to aid in the treatment in the most aggressive—and deadly—form of skin cancer. The test, THxID-BRAF, was developed by the French diagnostics firm bioMerieux, which has a U.S. subsidiary based in North Carolina. The test received approval from the U.S. Food and Drug Administration (FDA) last year. The assay is used to determine the genetic makeup of melanomas that afflict individual patients, particularly if they carry the BRAF V600E or BRAF V600K mutations. Both have responded positively to treatment with either Tafinlar or Mekinist, which are manufactured and distributed by GlaxoSmithKline and also received FDA approval last year. The drugs are intended to treat patients whose melanomas are metastatic or unresectable. Although most forms of skin cancer are easily treatable and rarely deadly, melanoma is the only form of the disease that will routinely infiltrate other parts of the body if left untreated. About 76,000 Americans are diagnosed with the disease every year. It kills about 9,700 each year. The five-year survival rate in the earliest stages of the disease exceeds 90 percent but fluctuates during the intermediary stages. The 10-year survival rates are as little as 40 percent at stage two. “The […]
Quest Diagnostics has introduced a test intended to aid in the treatment in the most aggressive—and deadly—form of skin cancer.
The test, THxID-BRAF, was developed by the French diagnostics firm bioMerieux, which has a U.S. subsidiary based in North Carolina. The test received approval from the U.S. Food and Drug Administration (FDA) last year. The assay is used to determine the genetic makeup of melanomas that afflict individual patients, particularly if they carry the BRAF V600E or BRAF V600K mutations. Both have responded positively to treatment with either Tafinlar or Mekinist, which are manufactured and distributed by GlaxoSmithKline and also received FDA approval last year.
The drugs are intended to treat patients whose melanomas are metastatic or unresectable.
Although most forms of skin cancer are easily treatable and rarely deadly, melanoma is the only form of the disease that will routinely infiltrate other parts of the body if left untreated. About 76,000 Americans are diagnosed with the disease every year. It kills about 9,700 each year. The five-year survival rate in the earliest stages of the disease exceeds 90 percent but fluctuates during the intermediary stages. The 10-year survival rates are as little as 40 percent at stage two.
“The addition of the THxID-BRAF test to our menu reflects our commitment to offering the most advanced dermatopathology testing available and to the field of precision medicine, which aims to improve outcomes based on a holistic clinical understanding of the patient,” said Frederic Waldman M.D., Quest’s medical director of cancer diagnostics. “The THxID-BRAF test further extends the services we provide for melanoma and other cancers across a continuum of care, giving physicians insights to help guide treatment decisions and empower better health. Because Quest reaches about half of the practicing physicians and hospitals in the United States, patients and providers will now have access to the THxID-BRAF test on a truly broad national scale.”
Takeaway: Quest’s decision to offer the THxID-BRAF assay is another indicator of the increasing importance of diagnostic tests that work in tandem with pharmaceutical regimens.
