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~ Veracyte, Inc., a leading cancer diagnostics company, has recently announced that their Decipher Prostate Genomic Classifier has received a "Level 1B" evidence rating in the 2024 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). This makes it the only gene expression test to receive this rating as a prognostic tool for risk stratification of patients with localized prostate cancer.
The Level 1B rating was assigned to Decipher Prostate based on the evidence in both post-biopsy and post-prostatectomy settings. This classification also sets the Decipher Prostate test apart as the only gene expression test for which the guidelines synthesize available published data in a separate table. This table summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score.
Elai Davicioni, Ph.D., medical director of Urology for Veracyte, commended the NCCN panel for their evidence synthesis and expert consensus that designated the Decipher Prostate test as the gene expression tool for risk stratification supported by the most clinical evidence across all stages of prostate cancer. He also noted that these recommendations reflect extensive clinical evidence generated through collaboration with clinical trial groups from around the world, including analysis of thousands of patients from practice-changing phase 3 studies. Davicioni believes that these guidelines will help physicians better utilize the Decipher Prostate test and tumor biology to provide optimal care for more patients with prostate cancer.
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The new NCCN Guidelines classify the Decipher Prostate test as Level 1B according to the "Simon Criteria," which are published criteria for assigning a level of evidence for clinical biomarkers based on quality and quantity of available evidence. The guidelines also summarize treatment implications for patients based on their Decipher score and published evidence from analyses of multiple randomized, phase 3 clinical trials.
The Decipher Prostate Genomic Classifier is a 22-gene test developed using RNA whole-transcriptome analysis and machine learning. It helps inform treatment decisions for patients with prostate cancer by providing an accurate risk of developing metastasis with standard treatment. This information allows physicians to personalize care for their patients, potentially recommending less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in over 75 studies involving more than 100,000 patients.
Veracyte is a global diagnostics company with a vision to transform cancer care for patients worldwide. Their Veracyte Diagnostics Platform delivers high-performing cancer tests fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine. This ultimately drives durable reimbursement and guideline inclusion for their tests, along with new insights to support continued innovation and pipeline development.
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For more information about Veracyte, please visit their website at www.veracyte.com and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements:
This article contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. Such risks and uncertainties include, but are not limited to: the success of Veracyte's efforts to develop new products; the impact of competition; the reimbursement rate for Veracyte's products; the ability to obtain necessary regulatory approvals; potential adverse impacts due to changes in healthcare policies or regulations; and other risks described in Veracyte's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed on February 22, 2021. Any forward-looking statements contained in this article speak only as of the date hereof, and Veracyte specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
The Level 1B rating was assigned to Decipher Prostate based on the evidence in both post-biopsy and post-prostatectomy settings. This classification also sets the Decipher Prostate test apart as the only gene expression test for which the guidelines synthesize available published data in a separate table. This table summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score.
Elai Davicioni, Ph.D., medical director of Urology for Veracyte, commended the NCCN panel for their evidence synthesis and expert consensus that designated the Decipher Prostate test as the gene expression tool for risk stratification supported by the most clinical evidence across all stages of prostate cancer. He also noted that these recommendations reflect extensive clinical evidence generated through collaboration with clinical trial groups from around the world, including analysis of thousands of patients from practice-changing phase 3 studies. Davicioni believes that these guidelines will help physicians better utilize the Decipher Prostate test and tumor biology to provide optimal care for more patients with prostate cancer.
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The new NCCN Guidelines classify the Decipher Prostate test as Level 1B according to the "Simon Criteria," which are published criteria for assigning a level of evidence for clinical biomarkers based on quality and quantity of available evidence. The guidelines also summarize treatment implications for patients based on their Decipher score and published evidence from analyses of multiple randomized, phase 3 clinical trials.
The Decipher Prostate Genomic Classifier is a 22-gene test developed using RNA whole-transcriptome analysis and machine learning. It helps inform treatment decisions for patients with prostate cancer by providing an accurate risk of developing metastasis with standard treatment. This information allows physicians to personalize care for their patients, potentially recommending less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in over 75 studies involving more than 100,000 patients.
Veracyte is a global diagnostics company with a vision to transform cancer care for patients worldwide. Their Veracyte Diagnostics Platform delivers high-performing cancer tests fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine. This ultimately drives durable reimbursement and guideline inclusion for their tests, along with new insights to support continued innovation and pipeline development.
More on The Californer
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For more information about Veracyte, please visit their website at www.veracyte.com and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements:
This article contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. Such risks and uncertainties include, but are not limited to: the success of Veracyte's efforts to develop new products; the impact of competition; the reimbursement rate for Veracyte's products; the ability to obtain necessary regulatory approvals; potential adverse impacts due to changes in healthcare policies or regulations; and other risks described in Veracyte's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed on February 22, 2021. Any forward-looking statements contained in this article speak only as of the date hereof, and Veracyte specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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