Superseded Local Coverage Article Response to Comments

Response to Comments: MolDX: myPath Melanoma Assay


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Response to Comments: MolDX: myPath Melanoma Assay
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Response to Comments
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The comment period for the MolDX: myPath Melanoma Assay DL37879 began on 10/04/2018 and ended on 12/14/2018. Comments were received from the provider community. The notice period begins on 04/18/2019 and ends 06/02/2019. The LCD becomes final on 06/03/2019.

Response To Comments


Many of these biopsies are from melanocytic tumors and in several instances the distinction between a benign nevus and malignant melanoma has been extremely difficult using light microscopy. This has resulted in significant inter-observer variance. Obviously, the treatment and prognosis are drastically different between benign and malignant melanocytic lesions.

More recently, molecular techniques have been developed to assist in this interpretation. MyPath Melanoma is one example of a test offered by Myriad Genetics that I have utilized to assist in the interpretation of difficult melanocytic neoplasms. The specificity and sensitivity of this test has been extensively studied for several years and have been found to be excellent.

Many dermatopathogists across the Northeast and nationally have been effectively utilizing and recognizing the value of the MyPath Melanoma test. Recognized experts in this field of melanoma concur. For all of these reasons, I strongly support your approval of this test.

Thank you for the comment. We hope that this test will enhance the diagnostic accuracy of pigmented skin lesions.


Over the past four years we have used the myPath Melanoma test extensively in our clinical practice to derive more definitive diagnoses for melanocytic neoplasms that could not be classified by clinical and histopathologic features alone.

It is critical that the accuracy of melanoma diagnostics also be validated by comparison to actual clinical outcomes and the clinical validation studies for the myPath test include the largest single cohort of melanocytic neoplasms with diagnoses supported by clinical outcomes.

I appreciate your thorough review of the myPath Melanoma assay, and I support the proposed local coverage determination. I know that this test will be helpful to specific Medicare patients I care for and I hope it will be available to them.

Thank you for the comment. We agree that validation of this assay against clinical outcomes is an important part of the supporting evidence.


I frequently consult on difficult melanocytic cases both within and outside of the Kaiser system. I find the myPath Melanoma test to be especially helpful in more difficult and ambiguous melanocytic lesions, and often use it to provide information which helps to make the correct diagnosis. Along with my professional expertise and experience, the published data available on both the validation and utility of the myPath Melanoma test provides the information I need to feel confident in using the myPath test in my practice. I strongly support your positive coverage decision for myPath.

Thank you for the comment. We hope that this test will enhance the diagnostic accuracy of pigmented skin lesions.


- Part of my academic mission is to test various methods for their potential to improve diagnostic accuracy. In this context I have collaborated with various investigators on the use of immunohistochemistry, cytogenetic methods (FISH, CGH, SNP array) as well as gene expression studies, including the myPath assay, and compared methods with each other.

My general experience:

- Based on my clinical practice (review of diagnostically controversial/difficult cases submitted by pathologists who have used the myPath test or other ancillary tests), I believe that the myPath test has significant clinical value for the work up of diagnostically problematic melanocytic lesions as a positive test result strongly correlates with the presence of a malignant melanoma.

- Based on my investigative experience comparing the myPath test results with cytogenetic and immunohistochemical methods for the work-up of diagnostically problematic melanocytic lesions, the myPath test results are as relevant and clinically useful as other methods, and sometimes even superior.

- There are situations, in which cytogenetic testing may not be feasible or simply falsely negative or positive, when the myPath test can still be performed, and lead to the correct diagnosis.

My confidence in the myPath test:

- No test is perfect, but if understood as a piece of a diagnostic puzzle, the myPath test results have significant clinical value to provide more diagnostic certainty for melanocytic lesions, which are equivocal based on the light microscopic findings alone. I have seen a number of cases, for which the use of the myPath test was essential to establish the correct final diagnosis.

I endorse the myPath test as a clinically useful ancillary test for the diagnosis of problematic melanocytic tumors. It is a welcome addition to our diagnostic armamentarium. Its results help guide the diagnosis and matter for related treatment decisions, leading to appropriate excision and staging when the diagnosis of melanoma is confirmed, or avoid unnecessary surgery when a negative test supports the impression of a probable benign or indolent tumor. By improving diagnostic accuracy it can lead to significant savings in the cost of care of patients with melanocytic tumors.

Thank you for the comment. We hope that this test will enhance the diagnostic accuracy of pigmented skin lesions.


I use the myPath Melanoma test in my clinical practice to help establish definitive diagnoses for occasional patients with melanocytic neoplasms that are equivocal by routine clinical and histopathologic examination. The accuracy of the myPath test has been confirmed in three separate clinical validation studies using three diverse patient cohorts, including one for which actual clinical outcomes (rather than histopathologic interpretation) served as the reference standard. In addition, multiple clinical utility studies have supported use of the test in clinical decision-making.

I appreciate your thorough review of the myPath Melanoma assay, and I support the proposed local coverage determination. I look forward to this test being available for my Medicare patients.

Thank you for the comment. We agree that validation of this assay against clinical outcomes is an important part of the supporting evidence.


Myriad Genetic Laboratories, Inc. appreciates the opportunity to comment on draft Local Coverage Determination (LCD) MolDX: myPath Melanoma Assay (DL37881). We are writing to express our support for the content of the draft LCD and to reiterate the importance of the proposed coverage for Medicare beneficiaries.

As described in the draft LCD, accurate diagnosis of melanocytic neoplasms is critical for patient outcomes. However, approximately 15% of biopsied lesions are difficult to diagnose and adjuncts to histopathology are needed to improve accuracy in equivocal cases. Three clinical validation studies collectively demonstrate the ability of myPath Melanoma to accurately differentiate malignant melanoma from benign nevi, with a sensitivity of 90-94% and a specificity of 91-96%. Two clinical utility studies demonstrate that patients with diagnostically challenging primary cutaneous melanocytic lesions tested with myPath Melanoma will have improved outcomes by comparison to untested patients, as defined by an increase in accurate diagnoses and a reduction in burdensome and unnecessary treatments.

We commend the Contractor Medicare Directors and the MolDx program for their thoughtful review of the myPath Melanoma assay and for providing dermatopathologists with access to an objective, reproducible, and accurate adjunctive test for differentiating melanoma from benign nevi, under the conditions defined in the draft LCD.

Thank you for the comment. We hope that this test will enhance the diagnostic accuracy of pigmented skin lesions.


A CAC member reiterated that many of the MolDX policies are based on similar tests that are provided by other labs, and posited that these could be just one particular provider trying to get coverage for their testing. For example, for the low risk prostate cancer disease, there are two other tests that are available that are genetic testing similar to that, the breast cancer gene expression test and the liquid biopsy for patients with lung cancer.

Thank you for the comment.

Associated Documents

Related Local Coverage Documents
DL37881 - (MCD Archive Site)
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
08/06/2023 06/03/2019 - 08/06/2023 Retired View
04/08/2019 06/03/2019 - N/A Superseded You are here