Covered by Medicare.

Prolaris® Prostate Cancer Genomic Assay

  • L36350: LCD for NCCN very low- and low-risk
  • L37082: LCD for NCCN favorable intermediate-risk

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Prognostic information independent of NCCN risk groups.

“Men with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups.

[Men with] favorable intermediate-risk prostate cancer (predominant Gleason grade 3 [i.e., Gleason score 3+4=7], and percentage of positive biopsy cores <50 percent, and no more than one NCCN intermediate risk factor) can be considered for active surveillance.”

National Comprehensive Cancer Network® NCCN Clinical Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 4.2019. Available at

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Prolaris promotes accurate selection of men for active surveillance.

“There is an urgency to incorporating newly available laboratory tools into the evaluation and management of prostate cancer to promote the accurate selection of men for active surveillance and to identify those who may be better served with multimodal treatment rather than monotherapy. Better patient selection for active surveillance will reduce the burden of over-treatment of indolent disease. Further, it is incumbent on urologists to obtain detailed family cancer histories and to consider hereditary genetic testing when family history patterns suggest risk.”

American Association of Clinical Urologists (AACU) and the Large Urology Group Practice Association (LUGPA). Position statement: Genomic testing in prostate cancer. February 2018.

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Gene expression profile (GEP) testing is a covered benefit when test results will impact treatment decisions.

“Prostate cancer tests Oncotype DX and Prolaris are covered only for low risk or favorable intermediate risk disease.”

Washington State Health Care Authority. Health Technology Clinical Committee Findings and Decision: Gene expression profile testing of cancer tissue, May 2018.

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