Veracyte’s Decipher Prostate Test Receives Highest Evidence-Level Rating Among Molecular Tests in Updated Prostate Cancer NCCN Guidelines
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Insights
The recent classification of the Decipher Prostate Genomic Classifier as a 'Level 1B' evidence tool in the NCCN Guidelines represents a significant endorsement of its clinical utility. From an oncological perspective, this test provides a nuanced risk stratification for patients with localized prostate cancer, which is crucial for tailoring treatment plans. The 'Level 1B' rating signifies that the test is supported by high-quality evidence from randomized, phase 3 clinical trials, which are the gold standard in clinical research. This means that the test has been proven to be predictive of clinical outcomes and can influence treatment decisions post-biopsy or post-prostatectomy.
Having a tool that can integrate with the NCCN's risk classification system allows for a more individualized approach to patient care. Incorporating genomic data with clinical parameters could lead to more precise prognostication and potentially better patient outcomes. The Decipher test's ability to guide treatment decisions based on tumor biology is a step forward in the practice of personalized medicine in oncology.
As a medical research analyst, the inclusion of the Decipher Prostate test in the NCCN Guidelines with a 'Level 1B' rating is indicative of its robust validation through extensive clinical evidence. The synthesis of data from thousands of patients across multiple phase 3 studies underscores the test's reliability and the reproducibility of its results. Furthermore, the unique provision of a separate table in the guidelines for treatment implications based on the Decipher score illustrates the test's integration into clinical decision-making processes.
For stakeholders, this development could potentially lead to broader adoption of the test, increased insurance coverage and a more favorable reimbursement environment. The rigorous evidence supporting the test's efficacy likely will bolster Veracyte's market position in cancer diagnostics, possibly impacting its financial performance positively in the long term.
The endorsement of the Decipher Prostate test by the NCCN Guidelines could have significant economic implications for the healthcare system. By stratifying patients more accurately based on their genomic profile, the test can help avoid overtreatment and the associated costs. In the short term, there may be an increase in the use of gene expression tests, which could raise immediate healthcare expenditures. However, in the long term, the potential for more personalized treatment plans may lead to cost savings by reducing unnecessary interventions and focusing resources on patients who are most likely to benefit from specific treatments.
From an economic standpoint, the adoption of such precision medicine tools could lead to an overall more efficient allocation of healthcare resources. It is also likely to influence the competitive landscape of the diagnostics industry, as other companies may seek to develop or improve their tests to meet or exceed the 'Level 1B' evidence standard.
“We commend the NCCN panel for their evidence synthesis and expert consensus that has again designated the Decipher Prostate test as the gene expression tool for risk stratification supported by the most clinical evidence across the spectrum of the disease and has uniquely provided clinical guidance that integrates a patient’s Decipher score,” said Elai Davicioni, Ph.D., medical director of Urology for Veracyte. “These recommendations reflect the extensive clinical evidence generated in collaboration with clinical trial groups from around the world from analysis of many thousands of their patients, including those from practice-changing phase 3 studies. Ultimately, we believe that these guidelines will help our customers better use the Decipher Prostate test and tumor biology to provide optimal care for more of their patients with prostate cancer.”
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 the quality and quantity of evidence available. They summarize the treatment implications for patients based on their Decipher score and the published evidence from analyses of multiple randomized, phase 3 clinical trials.
About the Decipher Prostate Genomic Classifier
The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, the physician can better personalize their patients’ care and may recommend 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 more than 75 studies involving more than 100,000 patients.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to our statements related to the potential NCCN Guidelines impact on physician’s better use of the Decipher prostate test. to our expectations the Decipher prostate test helps physicians better personalize their patients’ care in recommending less intensive versus more intensive treatment options. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to the impact we believe these guidelines will have in helping our customers better use the Decipher Prostate test and tumor biology to provide optimal care for more of their patients with prostate cancer. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on March 1, 2023 and our Quarterly Report on Form 10-Q filed for the three months ended September 30, 2023, filed on November 8, 2023. Copies of these documents, when available, may be found in the Investors section of our website at https://investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.
Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the
* 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.
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Source: Veracyte, Inc.
FAQ
What evidence rating did the Decipher Prostate Genomic Classifier receive in the 2024 NCCN Clinical Practice Guidelines?
What is the significance of the 'Level 1B' evidence rating for the Decipher Prostate test?
What criteria were used to classify the Decipher Prostate test as Level 1B in the NCCN Guidelines?
Who commended the NCCN panel for their evidence synthesis regarding the Decipher Prostate test?
What clinical guidance does the Decipher Prostate test provide according to the new NCCN Guidelines?
