Veracyte Announces Multiple Abstracts To Be Presented at ASCO, Demonstrating Power of Decipher GRID to Advance New Prostate and Bladder Cancer Research

Veracyte, Inc. (NASDAQ:VCYT), a leading cancer diagnostics company, today announced that eight abstracts featuring data derived from testing with its Decipher Prostate and Decipher Bladder genomic classifiers will be presented at ASCO, the annual meeting of the American Society of Clinical Oncology, being held May 30-June 3 in Chicago. Key findings shed new light on which patients with prostate or bladder cancer may be more likely to respond to specific therapies based on their tumors' molecular make-up.

"These new findings underscore the power of our whole-transcriptome-based Decipher GRID, or Genomic Resource for Intelligent Discovery, research tool to help advance understanding of urologic cancers at the molecular level," said Phil Febbo, M.D., Veracyte's chief scientific officer and chief medical officer. "We are pleased to share this resource with the research community to help reveal new insights that could one day enable more-personalized care and outcomes for patients with prostate or bladder cancer."

The following Decipher Prostate GRID-focused abstract will be shared in a podium presentation at the McCormick Place convention center:

Researchers found that patients whose metastatic prostate cancer had a PTEN-inactive gene expression signature were more likely to benefit from the addition of the chemotherapy, docetaxel, to standard androgen deprivation therapy (ADT), compared to those with PTEN-active tumors. Specifically, the PTEN-inactive patients had a 43% reduction in risk of death (HR=0.57, 95% 0.42-0.76), unlike PTEN-active patients where no benefit from docetaxel was observed (HR=1.05, 95% CI 0.77-1.43), with a significant interaction observed between docetaxel and PTEN status (p=0.002). Additionally, docetaxel benefited patients with PTEN-inactive tumors regardless of whether they had high- or low-volume prostate cancer. Finally, patients with tumors that were both PTEN-inactive and had high Decipher Prostate test risk scores had the greatest benefit from the addition of chemotherapy.

The study involved 832 patients with metastatic prostate cancer who were followed for a median of 14 years as part of STAMPEDE—a large, multi-center, randomized Phase 3 clinical trial that aims to determine the best way to treat men with newly diagnosed advanced or metastatic prostate cancer. Previously presented data showed that patients with high Decipher Prostate Genomic Classifier risk scores were more likely to benefit from the addition of docetaxel to ADT, compared to those with low Decipher test scores.¹

"It's well known that adding docetaxel to ADT increases survival for some patients with metastatic prostate cancer. The challenge has been knowing which patients will benefit and which ones will not so the latter can avoid unnecessary toxicity," said Emily Grist, Ph.D., of the University College London Cancer Institute who will present the new findings at the ASCO meeting. "Our results help to further elucidate molecular features of advanced prostate cancer, which may help us better select treatments for our patients."

The following Decipher Bladder GRID-focused abstract will be shared in a podium presentation at the ASCO meeting:

This study evaluated whether patients with muscle-invasive bladder cancer (MBIC) could potentially benefit from treatment with Sacituzumab Govitecan (SG) plus Pembrolizumab (Pembro), rather than standard-of-care chemotherapy, prior to radical cystectomy (RC). It also used the Decipher Bladder GRID research tool to identify patients who were more likely to achieve clinical complete response (cCR), based on the molecular underpinnings of their tumor.

"Interim results from SURE-02 trial revealed that neoadjuvant Sacituzumab Govitecan plus Pembrolizumab, followed by bladder sparing in complete responders and maintenance pembrolizumab was a safe and effective strategy in patients with MIBC," said Andrea Necchi, M.D., of IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University in Milan, Italy, who presented the findings. "Preliminary biomarker data developed by Veracyte as part of its Decipher Bladder test and GRID research tool, revealed associations between Luminal subtype and clinical complete response, or cCR, and immune signatures linked to the EFS gene that could ultimately help improve outcomes in molecularly-selected patients."

A more complete list of Decipher-focused abstracts to be presented at the ASCO meeting can be found on Veracyte's website here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

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 across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient's risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients' care. The Decipher Prostate test's performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN® Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder 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 or follow us on LinkedIn or X (Twitter).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements related to the potential power of Decipher Prostate and Decipher Bladder genomic classifiers to help advance understanding of urologic cancers at the molecular level; help reveal new insights that could one day enable more-personalized care and outcomes for patients with prostate or bladder cancer; that key findings shed new light on which patients with prostate or bladder cancer may be more likely to respond to specific therapies based on their tumors' molecular make-up; that our results help to further elucidate the molecular features of advanced prostate cancer, which may help us better select treatments for our patients; and that the Decipher Bladder test and GRID research tool revealed associations between Luminal subtype and clinical complete response and immune signatures linked to the EFS gene that could ultimately help improve outcomes in molecularly-selected patients. 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 Veracyte Diagnostics Platform can have on scientific advancements in cancer and, in turn, patient care. 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 28, 2025. 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.

¹ Grist et al. Decipher mRNA score for prediction of survival benefit from docetaxel at start of androgen deprivation therapy (ADT) for advanced prostate cancer (PC): An ancillary study of the STAMPEDE docetaxel trials. Presented at: Proffered paper session: GU tumors, prostate; ESMO Congress 2024; 2024 Sep; Barcelona, Spain.

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.

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