One-sentence summary:
Veracyte has launched its Decipher Prostate Metastatic Genomic Classifier, the only Medicare-covered gene expression test for guiding treatment decisions in metastatic prostate cancer.
Three brief takeaways:
- Expanded Coverage: The Decipher Prostate test now covers the full spectrum of prostate cancer, from localized to metastatic, with Medicare reimbursement.
- Clinical Impact: The test helps identify which metastatic prostate cancer patients may benefit from intensive treatment, avoiding unnecessary side effects.
- Proven Utility: Validated by multiple Phase 3 trials, the test is supported by Level I evidence in NCCN Guidelines for its clinical usefulness.
Veracyte, Inc., a genomic diagnostics company, has announced the launch of its Decipher Prostate Metastatic Genomic Classifier for use in patients whose prostate cancer has spread beyond the primary tumor. The Decipher Prostate test, already widely used for patients with localized disease, is now the only gene expression test available and covered by Medicare to inform treatment decisions for patients across the full continuum of prostate cancer risk.
Veracyte has begun making the Decipher Prostate Metastatic test available to select clinical sites through an early access program and will begin taking orders for the test more broadly in June 2025.
Prostate Cancer 2nd-Leading Cause of Cancer Deaths Among US Men
Prostate cancer is the second-leading cause of cancer deaths among men in the United States and the rate of men diagnosed with advanced disease has been growing in recent years.1 Veracyte estimates that approximately 10% (or about 30,000) of all prostate cancers diagnosed annually in the United States are metastatic.2
“A number of treatment options are now available to increase survival for patients whose prostate cancer has metastasized,” says Elai Davicioni, PhD, Veracyte’s medical director for Urology. “Until now, however, clinicians had limited ways to determine which of these patients will likely benefit from these therapies and which will not and may thus avoid their toxic side effects. We believe the Decipher Prostate Metastatic test will provide an important new tool to help clinicians make more-informed treatment recommendations for their patients with metastatic prostate cancer.”
Decipher Prostate Test Has Utility Clinically Validated
The Decipher Prostate test’s clinical validity and clinical utility for use in patients with metastatic prostate cancer have been demonstrated in multiple, prospective, Phase 3 clinical studies.3-6 These studies have shown that such patients with high Decipher scores are likely to have more-aggressive tumor biology compared to those with lower scores, informing the absolute benefit from treatment intensification. These findings build upon extensive data already established for the Decipher Prostate test’s use in patients with localized prostate cancer, where it is the only gene expression test to achieve “Level I” evidence status in the most recent NCCN Guidelines* for prostate cancer.
“Our expansion into metastatic prostate cancer underscores the power of the Veracyte Diagnostics Platform to uncover novel insights that can enable us to further help patients,” says Philip Febbo, MD, Veracyte’s chief scientific officer and chief medical officer.
Featured Image: The Decipher Prostate test, already widely used for patients with localized disease, is now the only gene expression test available and covered by Medicare to inform treatment decisions for patients across the full continuum of prostate cancer risk. Photo: Veracyte
* National Comprehensive Cancer Network. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
References
1 American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025.
2 Veracyte estimates.
3 Parry M, et al. Clinical qualification of transcriptome signatures for advanced prostate cancer (APC) starting androgen deprivation therapy (ADT) with or without abiraterone acetate and prednisolone (AAP): an ancillary study of the STAMPEDE AAP trial. Ann Oncol. 2022;33(Suppl 7):S1161.
4 Feng FY, Thomas S, Saad F, et al. Association of molecular subtypes with differential outcome to apalutamide treatment in nonmetastatic castration-resistant prostate cancer. JAMA Oncol. 2021;7(7):1005–1014.
5 Feng FY, et al. Molecular determinants of outcome for metastatic castration-sensitive prostate cancer (mCSPC) with addition of apalutamide (APA) or placebo (PBO) to androgen deprivation therapy (ADT) in TITAN. JCO 38, 5535-5535(2020).
6 Hamid AA, Huang HC, Wang V, et al. Transcriptional profiling of primary prostate tumor in metastatic hormone-sensitive prostate cancer and association with clinical outcomes: correlative analysis of the E3805 CHAARTED trial. Ann Oncol. 2021;32(9):1157-1166.
