What are the minimum tissue requirements for running a myPath® Melanoma test?
- Tissue samples can be submitted to Myriad as blocks or slides. Myriad requires one 3-5 micron H&E-stained slide most representative of the melanocytic lesion, followed by 5-8 consecutive 4-5 micron unstained sections on uncharged glass slides.
- A melanocytic lesion that is at least 0.5 mm x0.1 mm with a minimum of 10% cells of interest should be present on the H&E slide.
How should the myPath Melanoma score be interpreted?
- myPath Melanoma utilizes a gene signature measured by qRT-PCR to classify a sample as likely malignant, likely benign or indeterminate. A graph shows the patient’s score relative to the myPath Melanoma scores observed in the initial independent clinical validation cohort. Individual melanocytic lesions may or may not be representative of this cohort.
- A score range of -16.7 and +11.1 was established in the initial clinical validation study and scores within this range will be reported. When scores outside of the validated range are generated, it will lead to test cancelation.
- Scores from -16.7 to -2.1 are reported as likely benign; scores from -2.0 to -0.1 are reported as indeterminate (less than 10% of the cases are reported this way); scores from 0 to +11.1 are reported as likely malignant.
- See Technical Specifications for more information.
Is myPath Melanoma a clinically validated test?
Yes, myPath Melanoma is a clinically validated test. Results of the clinical validation study have been peer-reviewed and published in the Journal of Cutaneous Pathology: Clarke LE, Warf MB, Flake DD, et al. Clinical validation of a gene expression signature that differentiates benign nevi from malignant melanoma. J Cutan Pathol. 2015; 42:244-252.
What is the sensitivity and specificity of myPath Melanoma?
The test distinguished melanoma from benign nevi with 90% sensitivity and 91% specificity in the initial Clinical Validation study.
What is the diagnostic standard against which the myPath Melanoma score was validated?
Test performance was determined by comparing the score (as determined by the expression of the gene signature) to a 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). Histopathology is the current gold standard for diagnosis of melanocytic lesions. Performance was validated in an independent cohort of 437 melanocytic lesions representative of all major histological subtypes and derived from four independent institutions.
How is the area of the melanocytic lesion that is tested identified?
H&E-stained slides from each case are evaluated by a board certified pathologist who identifies and circles the location and amount of the lesion to be tested. Ordering physicians may circle the area of interest on the H&E-stained slide themselves if preferred.
Which genes are measured in the myPath® Melanoma signature?
myPath Melanoma measures RNA expression of 23 genes using quantitative reverse transcription polymerase chain reaction (qRT-PCR) technology. The genes analyzed are involved in three relatively distinct genetic pathways: 1) PRAME is a single gene that appears to regulate cell differentiation, 2) the S100A9 component contains 5 genes (S100A7, S100A8, S100A9, S100A12, PI3) that are involved in multiple cell signaling pathways; 3) the immune component contains 8 genes (CCL5, CD38, CXCL10, CXCL9, IRF1, LCP2, PTPRC, SELL) that regulate tumor immune response signaling. Nine housekeeping genes are measured to normalize RNA expression for analysis.
How should the myPath Melanoma score be used in the diagnosis of melanocytic lesions?
myPath Melanoma is an adjunctive diagnostic test designed to be used in conjunction with all other available clinical, molecular, and histopathologic data. Ordering physicians are encouraged to incorporate myPath Melanoma results into their final pathology reports according to their normal practice for clinically validated, adjunctive tests.
Is this test FDA cleared/approved?
- No. However, the FDA currently acknowledges that while Laboratory Developed Tests, such as myPath Melanoma are subject to FDA jurisdiction, the agency has chosen not to exercise regulatory authority over these tests. LDTs are governed by CMS under the Clinical Laboratory Improvement Amendments (CLIA).
- Myriad is in compliance with all necessary regulations and possesses all of the mandatory certifications required to perform the myPath Melanoma test. Myriad is CLIA certified and CAP accredited.
Is Myriad a CAP and CLIA-approved lab?
Is the H&E slide, unused slides and/or remaining tissue block tissue returned after testing?
Tissue blocks are returned in a timely matter. Any unused slides will also be returned upon completion of testing if requested by the provider.
Can a sentinel lymph node (SLN) or metastatic lesion be submitted for myPath Melanoma testing?
No. Performance characteristics of the myPath Melanoma test have not been established for tissue other than formalin-fixed paraffin-embedded (FFPE) primary melanocytic lesions from the skin. Thus, lesions from tissue types other than skin, non-melanocytic lesions, and metastatic melanocytic lesions will not be accepted for analysis at this time.
Is myPath® Melanoma validated in re-excision samples?
No. Performance characteristics of the myPath Melanoma test have not been established for re-excisional tissue. Re-excised lesions submitted for analysis will be subject to test cancelation.
Can more than one slide case or tissue block be sent in the same box?
Yes, however, please ensure that all the necessary forms such as Test Request Form and Pathology Report are included in the kit for each patient and that all are adequately labeled for identification. Please also be sure to place these forms in a separate envelope to maintain patient privacy before shipping.
Can multiple melanocytic lesions from the same patient be submitted for myPath melanoma testing?
Yes, multiple melanocytic lesions from the same patient can be submitted for testing.
Can more than one area from the same melanocytic lesion be tested?
No. Performance characteristics of the myPath Melanoma test have not been established for multiple tests from the same melanocytic lesion. However, multiple melanocytic lesions from the same patient can be submitted for testing.
I would like to submit a proposal for a case study, research project or publication. Who should I contact?
Feel free to complete Myriad’s Letter of Intent (LOI) template with details of your proposal. Completed LOIs can be returned to your Myriad Account Executive or emailed to myPathMed@myriad.com to be forwarded to the appropriate Myriad personnel for review and consideration.
Does a pathology report need to be submitted with each sample? Why?
Yes. Myriad’s laboratory personnel use the accompanying pathology report to ensure that all submitted information (Patient Identifier, Specimen ID and Block or Tissue Number) correlates with identifiers present on the tissue block or unstained slides. Providing the pathology report helps reduce the potential for error and enables Myriad to process your specimen in the most efficient manner possible.
Does the block number need to be specified on the TRF?
Yes, please specify the block number to ensure that all the information submitted, such as Patient Identifier, Specimen ID and Block/Tissue Number match.
Do I have to be enrolled in ResultsNOW™? I would like my results faxed.
Myriad ResultsNOW electronically delivers Myriad test results. Easily view your patient’s test results from anywhere there is an internet connection, View from your office, home, on any hand-held devices. If you prefer, a hardcopy of the results can be faxed or shipped to you via FedEx in lieu of electronic reporting.
Can my office staff have access to my ResultsNOW account?
Yes, each provider is allotted 5 delegates to their account. By adding delegates, your office staff will have access to all of your ResultsNOW information.
How soon are myPath® Melanoma results available?
Current turnaround time is approximately 5-7 business days from receipt of the test kit at our laboratory.
What are some reasons that a myPath Melanoma test might be canceled?
Inappropriate sample types can cause cancelation of the test. Inappropriate sample types include non-melanocytic lesions, re-excised lesions, samples not fixed in neutral buffered formalin, or samples from patients that received immunosuppressant or radiation treatments prior to biopsy. Also, samples that do not yield RNA that is of sufficient quantity or quality for testing will be canceled. A test may also be canceled if it produces a score that falls outside of the validated range of scores.
How should myPath Melanoma test results be incorporated into a final pathology report?
myPath Melanoma is an adjunctive diagnostic test and results should be considered within the context of all other available clinical, molecular, and histopathologic data when rendering a final diagnosis of a histopathologically ambiguous melanocytic lesion. Ordering physicians are encouraged to incorporate the results of the test into their pathology reports according to the standard practice they use for reporting other clinically validated, adjunctive tests. Sample report language as well as a “Dear Colleague” letter describing the test is available from your Myriad Account Executive upon request.