Retired Local Coverage Article Response to Comments

Response to Comments: MolDX: Androgen Receptor Variant (AR-V7) Protein Test

A58478

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Article ID
A58478
Article Title
Response to Comments: MolDX: Androgen Receptor Variant (AR-V7) Protein Test
Article Type
Response to Comments
Original Effective Date
03/25/2021
Retirement Date
10/11/2022
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Article Text

The comment period for the MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) DL37836 Local Coverage Determination (LCD) began on 10/30/19 and ended on 12/14/19. The notice period for L37836 begins on 03/25/2021 and will become effective on 05/09/2021.

The title of the LCD was revised from MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) to MolDX: Androgen Receptor Variant (AR-V7) Protein Test. The comment below was received from the provider community.

Response To Comments

NumberCommentResponse
1

This letter is to provide comments in support of our Local Coverage Determination submission for the Oncotype DX AR-V7 Nucleus Detect® test.

The Oncotype DX AR-V7 Nucleus Detect® test is the only clinically validated, commercially available test for men with metastatic castration-resistant prostate cancer (mCRPC) that identifies the androgen receptor splice variant 7 (AR-V7) protein in the nucleus of prostate cancer circulating tumor cells (CTCs). Localization of the constitutively activated AR-V7 protein in the nucleus of CTCs has been shown to be associated with reduced response to AR-targeted therapy and decreased overall survival.

The AR-V7 Nucleus Detect® test has been clinically validated to show the detection of AR-V7 protein in the nucleus of prostate CTCs is associated with AR-targeted therapy failure in men with mCRPC. All other competitive technologies on the market test for mutations or alterations in the AR gene or AR-V7 RNA levels or protein expression that is nucleus agnostic, i.e., protein can be localized to the nucleus and/or cytoplasm. Nuclear AR-V7 protein detection is associated with the most specific response to AR-targeted therapy and a better overall survival than nucleic-agnostic testing that quantifies AR-V7 RNA (Hazard Ratio [HR] 10.39, 95% Confidence Interval [CI] 2.1-5.1.47, p<0.0001;HR 4.27, 95% CI 1.77-10.27, p<0.0001, respectively).

Given these compelling clinical validation study results, we believe physicians and patients need the Oncotype DX AR-V7 Nucleus Detect® test to guide second line treatment decisions in castration-resistant prostate cancer patients.

Thank you for your comments and support of the policy. We have made the policy less provider specific in keeping with the desire for MolDx policies to be more foundational in nature.

Associated Documents

Related Local Coverage Documents
LCDs
L37836 - (MCD Archive Site)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/11/2022 03/25/2021 - 10/11/2022 Retired You are here
03/19/2021 03/25/2021 - N/A Superseded View

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