Download Test Result Myriad myPath® Melanoma Score: -1.5

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