October 15, 2013

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Article

Myriad Genetics Introduces Highly Effective Melanoma Test

Press Release

October 15, 2013

Salt Lake City – Myriad Genetics recently announced that results from a verification study showed the Myriad myPath Melanoma test effectively differentiated malignant melanoma from benign skin lesions.

The information provided by myPath Melanoma will give healthcare providers objective data and help to improve the diagnosis of patients with melanoma. Myriad presented these data at the American Society of Dermatopathology Annual Meeting on Oct. 13.

The verification study evaluated a 23-gene panel designed to differentiate malignant melanoma from benign skin lesions. The study analyzed 464 skin biopsy samples including 254 samples representing melanomas from all major subtypes including superficial spreading, lentigo maligna melanoma, acral, nodular and desmoplastic lesions.

Using this set of patient samples, the myPath Melanoma test demonstrated sensitivity of 89 percent and specificity of 93 percent at differentiating malignant melanoma from benign skin lesions.

"The data from this large cohort showed that this test is highly accurate, relative to expert dermatopathologic review, at differentiating malignant melanoma from benign skin lesions," said Sancy Leachman, director of the melanoma research program at the Knight Cancer Institute. "The diagnosis of melanoma by conventional methods often is subjective, and this test provides objective data which could make it an extremely valuable and useful diagnostic tool to help save patients' lives."

Melanoma is the most serious type of skin cancer. According to American Cancer Society statistics, about 76,000 new melanomas are diagnosed each year, and more than 9,000 people die from melanoma annually. Each year in the United States, there are approximately two million skin biopsies performed specifically for the diagnosis of melanoma. Approximately 14 percent or 280,000 biopsies are classified as indeterminate, which means the dermatopathologist cannot confidently determine whether the cells are benign or malignant.

"Patients and physicians with an indeterminate biopsy result face the challenging clinical question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer," said Loren Clarke, vice president of medical affairs of dermatology at

Myriad. "Late-stage melanoma has a five-year survival rate of 15 percent compared to early-stage melanomas that have five-year survival rates of about 90 percent. The ability to accurately diagnose and treat melanoma early on is critical to obtaining favorable long-term clinical outcomes."

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