On October 8, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new clinical outcomes and clinical utility data for myPath Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif (Press release, Myriad Genetics, OCT 8, 2015, View Source [SID:1234507671]). The findings add to the growing body of knowledge for myPath Melanoma and will support the Company’s clinical reimbursement dossier for the product.

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"The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."

A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows.

Podium Presentation

Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions.

Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT.

Location: Hilton Union Square, Continental 4-6.

Eugen Minca, M.D., department of Pathology, Cleveland Clinic, will present a study that correlates myPath Melanoma test results with clinical outcomes data (e.g., recurrence, sentinel lymph node metastases and distant metastases) from 127 patients with melanocytic lesions. Of these cases, 65 lesions were melanomas and 62 were benign lesions, according to the pathology diagnosis. The myPath Melanoma test scores were reviewed in conjunction with the diagnosis and clinical outcome. Of the 65 melanomas, 14 developed metastases and 51 had no adverse events after 47 months of follow up and myPath Melanoma diagnosed malignancy in all 14 cases with adverse outcomes, which represents a 100 percent sensitivity rate in these metastatic cases. There were no adverse events associated with the 62 benign lesions after an average follow up of 30 months. Of these, the myPath Melanoma test produced a benign score in 48 cases, an indeterminate score in seven cases and a malignant score in seven cases. Importantly, after myPath testing and upon expert histologic review, three of the seven cases with a malignant score were reclassified as melanomas. This is the first study with clinical outcome data and supports previous validation studies demonstrating that the myPath Melanoma test provides additional insight into difficult-to-diagnose lesions, supporting its use as an ancillary diagnostic test.

Poster Presentation

Title: A retrospective study of the influence of a gene expression signature on the treatment of melanocytic tumors.

Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at 11:00 a.m. PT.

Location: Golden Gate, Ballroom.

In this study, 632 difficult-to-diagnose melanocytic lesions were analyzed using the myPath Melanoma diagnostic test. Retrospective chart reviews were conducted for 315 of the cases to document the actual treatment carried out for each patient. Of these, 214 patients received a benign myPath Melanoma test result, 92 received a malignant result and nine received an indeterminate result. The percentage change was measured from the treatment recommendations of the expert dermatopathologists to the actual treatment provided by dermatologists. The results show that excisions were reduced by 33.1 percent in patients who received a benign myPath Melanoma test result. Conversely, the use of additional treatment, such as surgery, increased by 36.2 percent in patients who received a malignant myPath Melanoma test result. These data support the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists.

About myPath Melanoma

myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.

Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 14 percent or 210,000 biopsies are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: www.mypath.myriad.com and www.mypathmelanoma.com.