Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
CONFIDENTIAL Test Result MMM50035 ORDERING PHYSICIAN SPECIMEN Carson Jones MD Myriad Genetics 320 Wakara Way Salt Lake City, UT 84108 Specimen Type: Tissue: Anatomical Site: Biopsy Date: Accession Date: Report Date: PATIENT Tissue Block Skin Chest Mar 13, 2015 Feb 10, 2016 Feb 10, 2016 Name: Date of Birth: Patient ID: Gender: Accession #: Requisition #: Witherspoon, Jane 55-000-1 Female 07000026-BLD 07000026 Block(s) Analyzed: Myriad myPath® Melanoma Score: -1.5 Benign Indeterminate Malignant Myriad myPath® Melanoma Score Classification RESULT DESCRIPTION: Myriad myPath Melanoma utilizes a molecular signature measured by qRT-PCR that classifies a sample as malignant, benign or indeterminate. This graph shows your patient's Score relative to Myriad myPath Melanoma Scores according to the range of benign and malignant lesions in the independent validation cohort with a threshold of "0". For Scores from -16.7 to -2.1 the gene signature classification is benign; for Scores from -2.0 to -0.1 the gene signature classification is indeterminate (*less than 10% of the cases); for Scores from 0 to +11.1 the gene signature classification is malignant. A Score range of -16.7 and +11.1 was established in the validation study and Scores within this range will be reported. Scores outside of the validated range may lead to test cancelation or follow-up with the ordering physician. Individual lesions may or may not be representative of this cohort. INTENDED USE: This assay is intended for the in vitro analysis of melanocytic lesions to aid in the diagnosis of the lesion as benign or malignant. This is an adjunctive assay and should be used in conjunction with clinical data and histopathological features. Myriad myPath Melanoma has not been validated on metastatic melanomas, re-excision specimens, non-melanocytic neoplasms, or biopsies from a patient receiving immunosuppressant therapy or radiation treatment. Analysis of these samples may result in incorrect test interpretation; therefore these specimens are not suitable for testing and will be canceled. AUTHORIZED SIGNATURE: Loren E. Clarke, M.D. Benjamin B. Roa, Ph.D. Diplomate ABP Diplomate ABMG Board Certified in Laboratory Director Dermatopathology Medical Director, Dermatology Karla R. Bowles, Ph.D. Diplomate ABMG Laboratory Director Pharmacogenetics Kathryn A. Kolquist, M.D. Diplomate ABP, ABMG Laboratory Director Anatomic Pathology Johnathan M. Lancaster, M.D. Ph.D. Diplomate FACOG, FACS Chief Medical Officer The Myriad myPath Melanoma performance characteristics were determined by Myriad Genetic Laboratories. This test has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Myriad is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing. Myriad, the Myriad logo, myPath and the myPath logo are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions page 1 of 2 © 2015 Myriad Genetic Laboratories, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 800-469-7423 FX: 801-584-3615 CONFIDENTIAL Test Result MMM50035 ORDERING PHYSICIAN SPECIMEN Carson Jones MD Myriad Genetics 320 Wakara Way Salt Lake City, UT 84108 Specimen Type: Tissue: Anatomical Site: Biopsy Date: Accession Date: Report Date: PATIENT Tissue Block Skin Chest Mar 13, 2015 Feb 10, 2016 Feb 10, 2016 Name: Date of Birth: Patient ID: Gender: Accession #: Requisition #: Witherspoon, Jane 55-000-1 Female 07000026-BLD 07000026 Block(s) Analyzed: MOLECULAR ANALYSIS DESCRIPTION: The melanocytic lesion submitted is identified for macrodissection by a board certified pathologist at Myriad using H&E analysis. Analysis is then performed on total RNA extracted from FFPE tissue. The expression of 14 genes within the diagnostic signature are measured and normalized by 9 housekeeping genes. The gene expression measurements, by quantitative reverse transcription polymerase chain reaction (qRT-PCR), are taken in triplicate and analyzed to generate a Myriad myPath Melanoma Score. Based on an analysis of 437 melanocytic lesions in the validation study, a Score threshold of "0" was established to classify a sample as malignant, benign or indeterminate. The assay performance in this study was determined by comparing the Score (as determined by the expression of the gene signature) to the consensus diagnosis (as determined by comparing the pathology report and one independent, blinded review by a board-certified dermatopathologist with discordant diagnoses adjudicated by a third independent, board-certified dermatopathologist). In the validation cohort (for Scores outside the indeterminate classification), the gene expression signature had a sensitivity of 94% (95% CI of 90%-97%) and a specificity of 90% (95% CI of 85%-94%). Furthermore, 9% of total lesions were classified as indeterminate. For additional details and Technical Specifications for Myriad myPath® Melanoma visit myPathMelanoma.com | MyriadPro.com/technical-specifications REFERENCES: Clarke L et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma J Cutan Pathol 2015; 42:244-252. Warf MB et al. Analytical validation of a melanoma diagnostic gene signature using formalin-fixed paraffin-embedded melanocytic lesions. Biomark Med. 2015; 9(5):407-416. Myriad, the Myriad logo, myPath and the myPath logo are either trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other jurisdictions page 2 of 2 © 2015 Myriad Genetic Laboratories, Inc. | 320 Wakara Way, Salt Lake City, Utah 84108 | PH: 800-469-7423 FX: 801-584-3615 07000026 Carson Jones MD