Veracyte, Inc. announced the launch of its Decipher Prostate Metastatic Genomic Classifier, expanding the application of its widely used genomic test to patients whose prostate cancer has metastasized beyond the primary tumor. This development makes Decipher the only gene expression test available and covered by Medicare for patients across the full spectrum of prostate cancer risk levels.
The company has initiated an early access program at select clinical sites and plans to begin accepting broader orders for the test in June 2025.
Meeting Critical Needs in Metastatic Prostate Cancer
Prostate cancer remains the second leading cause of cancer death among men in the United States, with approximately 30,000 cases (about 10% of all prostate cancer diagnoses) classified as metastatic annually. The rate of advanced disease diagnoses has been increasing in recent years, highlighting the need for better treatment guidance tools.
"A number of treatment options are now available to increase survival for patients whose prostate cancer has metastasized," said Elai Davicioni, Ph.D., 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."
The Decipher test aims to address this clinical challenge by providing molecular insights that can guide more personalized treatment decisions.
Strong Clinical Evidence Supporting Expanded Use
The test's clinical validity and utility for metastatic prostate cancer patients have been demonstrated in multiple prospective Phase 3 clinical studies. Research has shown that patients with high Decipher scores typically exhibit more aggressive tumor biology compared to those with lower scores, which can inform decisions about treatment intensification.
These findings build upon extensive data already established for the test's use in localized prostate cancer, where it is the only gene expression test to achieve "Level I" evidence status in the most recent National Comprehensive Cancer Network (NCCN) Guidelines for prostate cancer.
Philip Febbo, M.D., Veracyte's chief scientific officer and chief medical officer, emphasized the significance of this expansion: "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."
How the Decipher Prostate Test Works
The Decipher Prostate Genomic Classifier is a sophisticated 22-gene test developed using RNA whole-transcriptome analysis and machine learning. The test is performed on biopsy or surgically resected tissue samples and provides information about cancer aggressiveness.
For patients with localized or regional prostate cancer, the Decipher score indicates the risk of metastasis, helping determine appropriate treatment timing and intensity. In metastatic disease, the score indicates the likelihood of cancer progression and potential survival benefit from treatment intensification.
The test's performance has been validated in over 85 studies involving more than 200,000 patients, establishing its clinical utility across the prostate cancer spectrum.
Impact on Clinical Practice
For oncologists and urologists treating metastatic prostate cancer patients, the expanded availability of the Decipher test represents a significant advancement in precision medicine. The test provides molecular information that can help clinicians make more informed decisions about which patients might benefit from more aggressive treatment approaches versus those who might be spared unnecessary side effects.
Metastatic prostate cancer occurs when cancer cells break away from the original tumor in the prostate gland and spread to other parts of the body, typically through the blood or lymph system. Common sites of metastasis include bones and lymph nodes. The disease primarily affects older men, and treatment decisions have traditionally been challenging due to the heterogeneous nature of the disease.
With the Decipher test now available for this patient population, clinicians have a new tool to help navigate these complex treatment decisions, potentially improving outcomes while minimizing unnecessary treatment toxicity.
