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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Evidence-based guidelines for molecular biomarkers in localized prostate cancer.

“Tissue-based molecular biomarkers (evaluating the sample with the highest volume of the highest Gleason pattern) may improve risk stratification when added to standard clinical parameters, but the Expert Panel endorses their use only in situations in which the assay results, when considered as a whole with routine clinical factors, are likely to affect a clinical decision.”

Eggener SE, et al. Molecular biomarkers in localized prostate cancer: ASCO guideline. J Clin Oncol 37, 2019.

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Prognostic information independent of NCCN or CAPRA risk groups.

“Men with low- or favorable intermediate-risk disease and life expectancy of greater or equal to 10 years may consider the use of the following tumor-based molecular assays: Decipher, Oncotype DX Prostate, Prolaris, and ProMark. Men with unfavorable intermediate- and high-risk disease and life expectancy greater than or equal to 10 years may consider the use of Decipher and Prolaris tumor-based molecular assays. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy (RP) specimens provide prognostic information independent of NCCN or CAPRA risk groups.”

National Comprehensive Cancer Network® NCCN Clinical Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 1.2020. Available at www.nccn.org.

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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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