Veracyte, Inc. (Nasdaq: VCYT) announced that new data presented today at the 24th Annual Meeting of the Society of Urologic Oncology (SUO 2023) highlight clinical observations and translational research conducted by users of the company’s Decipher Prostate Genomic Classifier. These independent, real-world studies provide further evidence supporting the clinical utility of the test in the treatment and management of prostate cancer, particularly for patients considering active surveillance.

Not all types of prostate cancer require immediate intervention; many can be monitored carefully over time with active surveillance, while more aggressive cancers have better outcomes with treatment. Identifying the appropriate candidates for active surveillance, however, is not always easy, as the clinical indicators used to assess patient risk often do not reliably distinguish between favorable and more aggressive disease.

Researchers at the Washington University School of Medicine in St. Louis presented two posters at the SUO meeting based on separate analyses of their Decipher biopsy cohort of 888 patients with prostate cancer who were seen at their institution between December 2016 and March 2023. In the first study, the researchers analyzed 235 patients who were initially managed with active surveillance, among whom 88 patients ultimately progressed to receive treatment. In evaluating clinical information available prior to treatment, including PSA levels, Gleason score, and results from magnetic resonance imaging (MRI), along with Decipher Prostate Genomic Classifier results, they found that the Decipher Prostate Genomic Classifier score was the only predictor of progression from active surveillance to treatment.

The second study focused on 104 patients who had a multiparametric MRI (mpMRI) result, Gleason Grade Groups 1-3 on biopsy, and Decipher testing prior to treatment with radical prostatectomy (surgery to remove the prostate). The researchers compared all of the available information prior to treatment to determine the best predictor of final pathology after prostatectomy. While multiparametric MRI (mpMRI) is often viewed as prognostic of cancer pathology, this study found that Decipher scores were strongly associated with final pathology, but clinical variables such as PSA levels, Gleason score and mpMRI were not. While mpMRI is often viewed as prognostic of cancer pathology, this study found that only Decipher scores were strongly associated with final pathology, while clinical variables such as PSA levels, Gleason score and mpMRI results were not.

“Accurately predicting disease progression in patients with prostate cancer is essential so they can receive the treatment that is best suited for them,” said Eric Kim, M.D., associate professor of surgery at Washington University School of Medicine in St. Louis and senior author of both posters. “Our studies consistently demonstrated that data from the Decipher Prostate Genomic Classifier was more reliably predictive of prostate cancer progression and underlying pathology than any other clinical data available, including MRI.”

Two other studies came from researchers at the University of Miami who used the ongoing Miami MAST prospective trial (MRI selection for active surveillance versus treatment; NCT02242773) to better understand cancer progression at the molecular level. In one study, researchers characterized 224 samples from 124 patients based on cancer progression. Assessment with the Decipher Prostate Genomic Classifier and biological insights from the Decipher Genomic Resource for Intelligent Discovery (GRID) research tool indicated that Decipher scoring was associated with grade progression, but not volume progression, of prostate cancer.

Finally, a large-scale, population-based study of over 52,000 patients tested with the Decipher Prostate biopsy test, led by investigators from the University of Michigan, found wide variation in Decipher risk distribution within and across clinical stage groups, suggesting that genomic assessment identified something that the clinical information does not. From this population-based initiative they concluded that integration of the test into clinical care can provide more precise prognosis estimates for patients and lead to better individualized risk assessment.

“We developed the Decipher Prostate Genomic Classifier to provide actionable information that helps guide patient care,” said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. “The data presented at SUO 2023 show how users of our test, conducting prospective research on their own patients, affirm the utility of Decipher in real-world settings. This real-world evidence and scientific research conducted by Decipher users shows how physicians can refine their surveillance or treatment plans based on a more comprehensive view of each patient’s cancer. We are very grateful for the work conducted by these clinician-scientists on behalf of the entire prostate cancer research community.”

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 high-performing tests enable clinicians to make more confident diagnostic, prognostic, and treatment decisions for some of the most challenging diseases such as thyroid, prostate, breast, bladder and lung cancers, as well as interstitial lung diseases. We help patients avoid unnecessary procedures and speed time to diagnosis and appropriate treatment. In addition to making our tests available in the U.S. through our central laboratories, we also aim to deliver our tests to patients worldwide through a distributed model to laboratories that can perform them locally. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to our clinical tests in and outside of the United States. Forward-looking statements can be identified by words such as: “appears,” "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will," “positioned,” “designed” and similar references to future periods. Examples of forward-looking statements include, among others, that integration of the Decipher Prostate Genomic Classifier into clinical care can provide more precise prognosis estimates for patients and lead to better individualized risk assessment; the Decipher Prostate Genomic Classifier can provide actionable information that helps guide patient care; and the Decipher Prostate Genomic Classifier can help physicians refine their surveillance or treatment plans based on a more comprehensive view of each patient’s 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. 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.

Decipher Prostate is available in the U.S. as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA. Veracyte, the Veracyte logo, and Decipher are registered trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and selected countries.

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