Decipher Prostate Test Now Available for Metastatic Prostate Cancer

Decipher Prostate Metastatic Genomic Classifier has been launched for use in patients whose prostate cancer has spread beyond the primary tumor, according to a news release from Veracyte, Inc.

The Decipher Prostate test, already widely used in localized disease, is now the only gene expression test covered by Medicare for all prostate cancer risk levels. Additionally, Veracyte has launched an early access program for its Decipher Prostate Metastatic test at select clinical sites and will begin accepting broader orders in June 2025.

“A number of treatment options are now available to increase survival for patients whose prostate cancer has metastasized,” Elai Davicioni, Veracyte’s medical director for Urology, said in the release. “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.”

The clinical validity and utility of the Decipher Prostate test in patients with metastatic prostate cancer have been confirmed in multiple prospective phase 3 studies. Patients with high Decipher scores were more likely to have aggressive tumor biology than those with lower scores, helping guide decisions on treatment intensification. These results add to existing data supporting the test’s use in localized prostate cancer, where it is the only gene expression test with Level 1 evidence in the latest NCCN Guidelines for prostate cancer, as per the release.

“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,” Dr. Philip Febbo, Veracyte’s chief scientific officer and chief medical officer, said in the news release.

The Decipher Prostate Genomic Classifier is a 22-gene test developed using RNA whole-transcriptome analysis and machine learning to guide treatment decisions for patients with prostate cancer. Performed on biopsy or surgically resected tissue, the test assesses cancer aggressiveness. In localized or regional disease, the Decipher score predicts risk of metastasis to help inform treatment timing and intensity.

In metastatic disease, the score indicates the likelihood of progression and potential survival benefit from treatment intensification. The test’s clinical utility has been demonstrated in more than 85 studies involving over 200,000 patients. It is the only gene expression test with “Level I” evidence and inclusion in the risk-stratification table of the latest NCCN Guidelines for prostate cancer.

Prostate cancer is the second leading cause of cancer death among men in the United States, and diagnoses of advanced disease have been rising in recent years. Veracyte estimates that about 10%, or 30,000, of prostate cancers diagnosed each year are metastatic.

Metastatic prostate cancer occurs when prostate cancer, which forms in the tissues of the prostate gland located below the bladder and in front of the rectum, spreads to other parts of the body, according to the National Cancer Institute. This disease typically affects older men.

Furthermore, in metastasis, cancer cells break away from the original tumor and travel through the blood or lymph system to form new tumors in other organs or tissues. These new tumors are made up of prostate cancer cells, not cells from the area where the tumor has spread. Common sites of metastasis include the bones and lymph nodes.

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