COMPANY:

Veracyte

"On the heels of the landmark OPTIMA trial readout presented at the ASCO Annual Meeting, Veracyte...today announced the U.S. commercial launch of the Prosigna® Breast Risk of Recurrence (ROR) test, a genomic test for patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer. The Prosigna test determines a patient’s ROR score and estimates the 10-year probability of distant recurrence, providing prognostic insight into how a patient’s cancer may behave over time. These insights also help guide treatment decisions, including predicting whether high risk patients are likely to benefit from chemotherapy or may safely achieve optimal outcomes with endocrine therapy alone, enabling clinicians to make personalized care plans for their patients. The Prosigna test will be available to order starting June 8, 2026."

''Veracyte, Inc...announced today results from the independent OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) trial, led by University College London (UCL). The results, which will be presented at the ASCO Annual Meeting, conclude that the Prosigna® Breast Risk of Recurrence (ROR) test safely guides adjuvant chemotherapy decisions in patients with early-stage, ER-positive HER2-negative breast cancer.''

"Veracyte, Inc...announced today that data from two significant phase III clinical trials using its Prosigna Breast and Decipher Prostate tests will be presented at the 2026 ASCO Annual Meeting in Chicago, taking place May 29 – June 2. The OPTIMA and ENZAMET trial presentations are expected to provide practice-changing evidence demonstrating how Veracyte’s genomic tests can guide treatment decisions in both early-stage breast cancer and metastatic prostate cancer."

"Veracyte, Inc...today announced that its TrueMRD Monitoring Test has received coverage from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) for patients with muscle-invasive bladder cancer (MIBC). The TrueMRD Test is covered for recurrence monitoring following definitive treatment with curative intent in patients with MIBC. It will be available for clinicians to order on June 1, 2026, marking the commercial launch of Veracyte’s first minimal residual disease (MRD) offering and the only commercially available truly whole-genome MRD test to come to market, expanding the company’s reach into cancer recurrence monitoring."

P2 | "Prior local therapy, radiation to metastases and docetaxel were permitted... The primary objective was achieved with 41% of favorable responders to TS+ARPI remaining treatment-free with testosterone recovery at 18 mo after TI. Analyses of biomarkers and PROs are in progress, and pts will be followed for long-term outcomes. Support: U10CA180821, U10CA180882, UG1CA189823, https://acknowledgments.alliancefound.org, Veracyte Inc."

"Veracyte, Inc...announced today more than 15 abstracts featuring its urology portfolio will be presented at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU). The abstracts span studies across prostate and bladder cancers, featuring real-world data for Decipher Prostate and new insights from phase II clinical trials, including one utilizing the company’s upcoming TrueMRD™ Muscle-Invasive Bladder Cancer (MIBC) test."

"Veracyte, Inc...today announced the launch of its Decipher Prostate Metastatic Genomic Classifier for use in patients whose prostate cancer has spread beyond the primary tumor. The Decipher Prostate test, already widely used for patients with localized disease, is now the only gene expression test available and covered by Medicare to inform treatment decisions for patients across the full continuum of prostate cancer risk."

P2 | N=282 | TOMBOLA (NCT04138628) | "The findings, from the large, independent, multicenter, interventional TOMBOLA trial (NCT04138628), were shared in an oral presentation at the 40th Annual European Association of Urology Congress (EAU25) in Madrid....At the 6-month milestone, in comparison to ddPCR, the Veracyte MRD testing platform had an equivalent and outstanding negative predictive value (95.9% Veracyte MRD vs. 96.2% ddPCR) for cancer recurrence, while having a higher specificity (88% Veracyte MRD vs. 62% ddPCR). Longer follow-up is required to determine the clinical impact of these results. The findings also showed that the Veracyte MRD testing platform detected cancer recurrence a median of 93 days sooner than imaging."

"Veracyte...announced that multiple abstracts will be presented at the 40th Annual European Association of Urology Congress (EAU25) demonstrating the clinical performance and utility of its Decipher tests in prostate and bladder cancer. Additionally, independent performance data supporting the company’s minimal residual disease (MRD) testing platform for muscle-invasive bladder cancer will be unveiled from a large, multicenter trial. The EAU25 meeting is taking place March 21-24 at IFEMA Madrid in Spain."

"Veracyte, Inc...today announced that new data presented at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) demonstrate the performance and clinical utility of its Decipher Prostate and Decipher Bladder tests to help guide treatment for patients with prostate and bladder cancer."

"Veracyte, Inc...today announced that new data presented at the 2025 ASCO Genitourinary Cancers Symposium (ASCO GU) demonstrate the performance and clinical utility of its Decipher Prostate and Decipher Bladder tests to help guide treatment for patients with prostate and bladder cancer."

"Veracyte, Inc...today announced new data that reinforce the ability of its Decipher Bladder Genomic Subtyping Classifier to help improve staging for patients with bladder cancer, based on their tumors’ molecular subtype. The findings, published in European Urology Open Science, show that the test can help clinicians better determine which patients are more likely to harbor more aggressive disease than suggested by their initial clinical staging following transurethral resection of bladder tumor (TURBT)."