COMPANY:

Veracyte

"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 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)."

"Veracyte, Inc...today announced that its market-leading Decipher Prostate Genomic Classifier is the only gene expression test to be included in version 1 of the 2025 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as part of the updated “Advanced Tools” table located in the Principles of Risk Stratification and Biomarkers section (PROS-H) ."

P=Obs | N=240 | VANDAAM (NCT02723734) | "Veracyte, Inc...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....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)."

P2/3 | N=11,922 | STAMPEDE (NCT00268476) | "In the new study, researchers analyzed data for 1,523 patients with advanced or metastatic prostate cancer who were followed in the STAMPEDE trial for a median of 14 years. They found that higher Decipher Prostate test scores were associated with an increased risk of death in both groups. Additionally, among the 832 patients with metastatic disease, only those with higher Decipher Prostate scores received a significant survival benefit from the addition of docetaxel to ADT. These patients had a 36% reduction in risk of death (HR 0.64, 95% CI, 0.48-0.86) with the addition of docetaxel as compared to those with lower Decipher scores who did not significantly benefit (HR 0.96, 0.71-1.30; interaction p=0.039)."

"Veracyte, Inc...announced new research findings suggesting the potential of novel molecular signatures to identify patients with thyroid nodules or cancer who have aggressive disease. The findings, which could potentially help clinicians further individualize care based on each patient’s tumor biology, are derived from research using Veracyte’s Afirma GRID (Genomic Resource for Intelligent Discovery) tool. The results were presented today at ENDO 2024, the annual meeting of The Endocrine Society in Boston."

"Veracyte, Inc...announced new research findings suggesting the potential of novel molecular signatures to identify patients with thyroid nodules or cancer who have aggressive disease. The findings, which could potentially help clinicians further individualize care based on each patient’s tumor biology, are derived from research using Veracyte’s Afirma GRID (Genomic Resource for Intelligent Discovery) tool."

"Veracyte, Inc...announced that data from three studies will demonstrate the power of the Afirma GRID (Genomic Resource for Intelligent Discovery) tool to help unlock new molecular insights into thyroid tumors, which may ultimately help to further personalize treatment of the disease."

"The UK National Institute for Health and Care Excellence (NICE)...recommended three prognostic gene expression tests as tools for guiding adjuvant chemotherapy treatment decisions in an expanded population of early breast cancer patients...In a final guidance, NICE said Myriad Genetics' EndoPredict (which is being sold to Eurobio), Veracyte's Prosigna, and Exact Sciences' Oncotype DX can be used within the National Health Service (NHS) to guide adjuvant treatment for postmenopausal women or men with estrogen receptor-positive, HER2-negative early breast cancer and one to three positive lymph nodes."