Findings are from the prospective, multicenter VANDAAM trial

Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, announced that new data from the multicenter, prospective VANDAAM trial show that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer among African American men with early-stage disease. The findings confirm that the market-leading genomic test offers clinicians an improvement over clinical factors alone in guiding prostate cancer treatment decisions for African American men, a population that is disproportionately impacted by the disease. The new data were shared today in an oral presentation at ASTRO 2024, the annual meeting of the American Society for Radiation Oncology, in Washington, D.C.

African American men are more than 70% as likely to be diagnosed with prostate cancer and more than twice as likely to die of the disease, compared to white men, according to the American Cancer Society.¹ Despite this, few prospective studies have specifically sought to examine the disease at a genomic level in this population.

“We intentionally recruited African American men into the VANDAAM trial to enable a one-to-one match with non-African American men with similar clinical factors,” said Kosj Yamoah, M.D., Ph.D., chair of the Department of Radiation Oncology at the H. Lee Moffitt Cancer Center & Research Institute and presenter of the data at the ASTRO meeting. “Our results showed that the Decipher Prostate test was highly accurate in predicting aggressive prostate cancer in both groups. These findings confirm that use of the genomic test in African American men could potentially enable better treatment decisions and outcomes, helping to reduce outcome disparities for this population.”

The VANDAAM trial enrolled men with low- or intermediate-risk prostate cancer as classified by the National Comprehensive Cancer Network (NCCN) Guidelines^® for Prostate Cancer. For the current analysis, researchers evaluated data for a clinically balanced cohort of 226 men (113 African American men and 113 non-African American men) and performed genomic analysis using the Decipher Prostate classifier to generate Decipher risk scores.

Following standard treatment, patients with high Decipher test scores were eight times more likely to have biochemical recurrence within 2 years (BCR; i.e., a rise of prostate-specific antigen levels in the blood, which was used as a surrogate for aggressive disease), compared to those with lower genomic test scores (HR = 7.93, 95% CI, 1.65 – 33.04, p = 0.008). When adjusted for other variables, such as age, race, pre-treatment prostate specific antigen (PSA), and Gleason score, those patients with high Decipher test scores remained at significantly high risk of rapid-onset BCR (HR = 10.37, 95% CI, 1.94-55.35, p = .006). There was no significant difference in the results between African American and non-African American men.

“The Decipher Prostate test’s ability to accurately predict risk of a patient’s prostate cancer progressing has already been demonstrated in dozens of clinical studies,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “While prior retrospective data showed that Decipher is highly prognostic in African Americans, these patients have historically been under-represented in biomarker clinical studies. We applaud the VANDAAM study team for conducting the first prospective clinical trial to examine the effectiveness of genomic risk-stratification in African American men – results that could potentially help to narrow the prostate cancer disparity gap.”

“These new data further demonstrate the power of the Veracyte Diagnostics Platform to further our mission of transforming cancer care for all patients,” said Marc Stapley, Veracyte’s chief executive officer. “Our comprehensive, whole-transcriptome approach enables us to develop high-performing tests, such as Decipher Prostate, that are validated across different patient populations and can help address differences in tumor biology and minimize disparities in outcomes. We believe this ability is key to helping to overcome gaps in cancer care.”

About Decipher Prostate

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, physicians 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 many dozens of published studies involving more than 100,000 patients and is the only gene expression test to achieve ‘Level 1B’ evidence status in the most recent NCCN^® Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

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 for the use of the Decipher Prostate test in African American men to enable better treatment decisions and outcomes, helping to reduce outcome disparities for this population; and help to narrow the prostate cancer disparity gap. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed,” "ultimately," 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 potential impact the Decipher Prostate test can have on scientific advancements in prostate cancer and, in turn, patients. 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 February 29, 2024 and our subsequent Quarterly Reports on Form 10-Q. 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.

Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and selected countries.

¹ American Cancer Society. Cancer Facts & Figures for African American/Black People 2022-2024. Atlanta: American Cancer Society, 2022.

* 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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