Veracyte’s Decipher Prostate Test Receives Highest Evidence-Level Rating Among Molecular Tests in Updated Prostate Cancer NCCN Guidelines

February 27, 2024 at 17:55 PM EST

Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a “Level 1B” evidence rating in the 2024 NCCN^* Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) as a prognostic tool for the risk stratification of patients with localized prostate cancer. Level 1B was assigned to Decipher Prostate based on the evidence in both the post-biopsy and post-prostatectomy settings. Additionally, because of this classification, the Decipher Prostate test is the only gene expression test for which the guidelines synthesize the available published data in a separate table that summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score.

“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 U.S. and selected countries.

* 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.