COMPANY:

Veracyte

P2 | N=227 | ENACT (NCT02799745) | Sponsor: Astellas Pharma Global Development, Inc.| "Veracyte, Inc...today announced that a new study published in JCO Precision Oncology shows that, among patients undergoing Active Surveillance (AS) for prostate cancer, the Decipher Prostate Genomic Classifier is prognostic for identifying those whose disease is likely to progress...The new findings are from the biomarker analysis study of the ENACT clinical trial (NCT02799745) that aimed to compare the efficacy and safety of enzalutamide monotherapy plus AS vs AS alone in patients with low-risk or intermediate-risk prostate cancer....In the AS alone or control arm, among patients with available tumor samples (n=65), the Decipher Prostate test predicted increased rates of disease progression after adjusting for baseline clinical risk factors (MVA HR [95% CI] per 10% increase in score: 1.17 [1.01 to 1.35]; P = 0.04)."

"Veracyte, Inc...today announced that nine abstracts focused on its Decipher Prostate and Decipher Bladder Genomic Classifiers will be presented at AUA 2024, the annual meeting of the American Urological Association, taking place May 3-6 in San Antonio. Studies to be presented include those that evaluate the clinical utility of the company’s Decipher tests in guiding treatment decisions for patients with prostate or bladder cancer. Other presentations will explore new insights into these cancers’ underlying biology, which researchers derived through use of Veracyte’s whole-transcriptome-based Decipher GRID research tool."

"Veracyte...announced that its Decipher Prostate Genomic Classifier is the only gene expression test to receive a 'Level 1B' evidence rating in the 2024 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a prognostic tool for the risk stratification of patients with localized prostate cancer. Level 1B was assigned to Decipher Prostate based on the evidence in both the post-biopsy and post-prostatectomy settings. Additionally, because of this classification, the Decipher Prostate test is the only gene expression test for which the guidelines synthesize the available published data in a separate table that summarizes treatment implications for patients based on both their NCCN risk classification and Decipher score."

"Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced it has completed its acquisition of C2i Genomics, Inc., adding whole-genome minimal residual disease (MRD) capabilities to its novel diagnostics platform and expanding the company’s ability to serve patients across the cancer care continuum."

"The company also announced it has reached a definitive agreement to acquire C2i Genomics, Inc. a minimal residual disease (MRD) detection company, adding whole-genome MRD capabilities to its novel diagnostics platform and positioning Veracyte to expand its offerings along the cancer care continuum. Under the terms of the agreement, Veracyte will pay $70 million in Veracyte shares at closing, and up to an additional $25 million based on the achievement of future performance milestones over the next two years, payable in Veracyte shares or cash at Veracyte’s election."

"Veracyte...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."

"Veracyte...announced that clinical validation data published in the journal CHEST show that the company’s Percepta Nasal Swab test determines lung cancer risk, with high accuracy, among people who currently smoke or have previously smoked and have lung nodules. The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment."

"Veracyte, Inc...announced that seven posters will be presented at the 24th Annual Meeting of the Society of Urologic Oncology (SUO 2023), where they will demonstrate the clinical performance of Veracyte’s Decipher Prostate Genomic Classifier in identifying patients whose prostate cancer is likely to progress and require treatment. Collectively, the posters will report data from more than 60,000 patients. The meeting will take place in Washington, DC, from November 28 to December 1."

"Veracyte...announced that it has entered into a multi-year agreement with Illumina...to develop and offer some of its high-performing molecular tests as decentralized in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx next-generation sequencing (NGS) instrument...The first tests that Veracyte plans to develop for the Illumina NextSeq 550Dx instrument are its Prosigna Breast Cancer Assay and Percepta Nasal Swab test. Prosigna is already commercially available as an IVD test that helps inform treatment decisions for patients with early-stage breast cancer."

"Veracyte, Inc...today announced that two poster presentations taking place at SITC 2023, the annual meeting of the Society for Immunotherapy of Cancer, in San Diego from November 3-5 will demonstrate the potential for using the company’s novel tools to help advance the development of immuno-oncology drugs. These tools allow for better characterization of the tumor microenvironment (TME), which can enable new insights into drug response and mechanisms of resistance....'These conference presentations will show that Veracyte’s Brightplex and Immunoscore IC tools can offer scientists a clearer view of the tumor microenvironment, as well as data that could inform immuno-oncology drug development.'"

"OncoDNA...announced the next stage in its partnership with C2i Genomics...The lab uses C2inform, the first CE-IVDD marked software-as-a-medical-device molecular residual disease (MRD) test."

"Veracyte...announced that new data from a large, randomized phase 3 trial reinforce the value of the Decipher Prostate Genomic Classifier in helping physicians make more informed treatment decisions for their patients with prostate cancer. The findings, presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, suggest that the Decipher Prostate test can categorize more accurately risk of patients with clinically high-risk disease to help inform appropriate treatment."

"Veracyte...announced that six abstracts highlighting new data from studies evaluating the company’s Decipher Prostate Genomic Classifier and related capabilities will be presented, three as oral presentations, at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2023 taking place October 1-4 in San Diego."

"Veracyte...announced that six abstracts highlighting new data from studies evaluating the company’s Decipher Prostate Genomic Classifier and related capabilities will be presented, three as oral presentations, at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2023 taking place October 1-4 in San Diego."

"Veracyte...announced that three posters showcasing new data from the company’s Afirma Genomic Sequencing Classifier (GSC) will be presented at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, DC from September 27 to October 1. Together, these abstracts offer novel insights into the molecular underpinnings of thyroid nodules and tumors based on whole-transcriptome RNA sequencing data from thyroid nodules analyzed with the Afirma GSC."

P2 | N=38 | STREAM (NCT02057939) | "The findings, from the Phase 2 STREAM study, suggest the potential to use transcriptomic signatures to identify patients in this setting who may benefit from more intensive salvage therapy as well as those who may need alternative care such as chemotherapy....Results suggest that patients in the study who experienced shorter progression-free survival (PFS) over three years had a luminal proliferating tumor subtype, loss of the PTEN gene and/or higher homologous recombination deficiency (HRD) signature scores. Patients with luminal differentiated or luminal A-type tumors and/or higher postoperative ADT responsiveness genomic signature scores were more likely to have durable responses and long-term remissions with the aggressive systemic regimen of ADT and enzalutamide combined with salvage radiotherapy."

"C2i Genomics...announced its strategic collaboration with the Tel Aviv Sourasky Medical Center (Ichilov)...Together, the organizations will provide precision oncology clinical testing using C2inform, C2i Genomics’ whole genome minimal residual disease (MRD) test to improve cancer detection and monitoring nationwide."

"Veracyte, Inc...announced the publication of a large, real-world study reinforcing the Decipher Prostate Genomic Classifier’s ability to guide personalized treatment approaches for men with prostate cancer. The study utilized data from the first linkage of prostate cancer cases reported by central cancer registries participating in the Surveillance, Epidemiology, and End Results (SEER) Program, with Decipher test results....The results demonstrated that AS/WW was highest among subjects with low-risk Decipher biopsy results (41%), compared to those who had intermediate-risk (27%) or high-risk (11%) scores. Among subjects with clinically low-risk prostate cancer, 65% of those with low-risk Decipher results were managed with AS/WW."

"Veracyte...announced that new data presented at ENDO 2023, the annual meeting of The Endocrine Society, suggest the company’s Afirma molecular testing and whole-transcriptome capabilities can provide novel insights that may advance the scientific understanding of thyroid nodule biology. In addition, findings from an analytical validity study presented at the meeting show that the Afirma TERT promoter mutation test performs with high analytical sensitivity and specificity."

"Veracyte...announced that three abstracts highlighting new data on the company’s Afirma test and capabilities will be presented at ENDO 2023, the annual meeting of The Endocrine Society, which is taking place June 15-18 in Chicago, Ill. Additionally, Veracyte’s medical director of Endocrinology, Joshua Klopper, M.D., will participate in a symposium panel discussion on the advantages of various molecular testing approaches to help personalize and improve care for people with potentially cancerous thyroid nodules."

"Veracyte...announced that new data to be shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrate the ability of the company’s Decipher Genomics Resource for Intelligent Discovery (GRID) database to enable novel molecular insights into prostate cancer. The findings, from three separate studies, may ultimately help inform more personalized treatment for patients with prostate cancer."

"Veracyte...today announced new data suggesting its novel genomic tests may positively impact diagnosis and care for patients being evaluated for interstitial lung disease (ILD) or lung cancer. The findings were presented at ATS 2023, the annual meeting of the American Thoracic Society, which is being held May 21-24 in Washington, D.C....An Envisia-positive result for UIP prompted an increase in use of anti-fibrotic drugs (from 11.9% to 71.4%), which are used to treat IPF and other progressive ILDs. An Envisia-positive result for UIP also led to a reduction in immuno-suppressant drugs (from 23.8% to 9.5%), which can be harmful to patients with IPF."

P=NA | N=2,164 | "Veracyte, Inc...announced that new data show the use of the Prosigna Breast Cancer Assay altered treatment decisions for patients with early-stage breast cancer, including significantly reducing the use of chemotherapy among those with clinically high-risk disease....These initial data focused on treatment decisions and were shared in a poster (#103P) today at ESMO Breast Cancer Congress 2023, taking place May 11-13 in Berlin....The researchers found that use of Prosigna changed adjuvant therapy decisions for almost one-third (29%) of patients. Notably, for patients assigned to chemotherapy prior to Prosigna results, 45% were de-escalated to endocrine therapy following Prosigna results."

"Veracyte...announced findings from a large-scale, systematic literature review showing that TERT promoter gene mutations in thyroid nodules deemed indeterminate by cytopathology are rare, but have a high risk of malignancy and, in certain cases, are associated with aggressive tumor behavior. The data are being presented at the American Association of Clinical Endocrinology (AACE) 2023 Annual Meeting, being held May 4-6 in Seattle, and reinforce the value of Veracyte’s expanded Afirma offering, which now includes TERT promoter mutation testing."

"Veracyte...announced that data published in the journal Cancer show the ability of a novel gene expression signature to classify prostate cancer into distinct molecular subtypes that may inform which tumors are more likely to respond to different treatments. The findings suggest that the novel biomarker, derived largely using Veracyte’s Decipher Genomics Resource for Intelligent Discovery (GRID) database, could potentially enable physicians to further personalize care for their patients with prostate cancer."

"Veracyte...announced that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, 'The Red Journal') validate the clinical utility of the company’s Decipher Prostate Genomic Classifier for helping to guide treatment selection in men with intermediate-risk prostate cancer. The findings are from NRG Oncology/RTOG 0126, a Phase 3 randomized clinical trial of patients with intermediate-risk prostate cancer treated with definitive radiotherapy without concomitant hormone therapy. This is the first randomized study to validate any gene-expression biomarker in this patient population, adding further evidence to support the Decipher Prostate test’s utility."

"Veracyte...announced that three abstracts focused on the company’s genomic tests for interstitial lung disease (Envisia Genomic Classifier) and lung cancer (Percepta Nasal Swab) will be presented at the American Thoracic Society (ATS) 2023 International Conference. The meeting will take place May 19-24 in Washington, D.C."

"Veracyt...announced that new data presented at the American Urological Association (AUA) 2023 Annual Meeting validate the real-world performance and clinical utility of the company’s Decipher Prostate Genomic Classifier. The findings are from two separate, large-scale studies evaluating the Decipher Prostate test among a total of more than 100,000 individuals with prostate cancer and reinforce its role as a new standard of care to help inform treatment decisions for these patients."

"Veracyte...announced that five abstracts providing new molecular insights into prostate and other cancers will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago and online June 2-6. Three of the accepted abstracts leverage Veracyte’s Decipher GRID (Genomic Resource for Intelligent Discovery) database to explore potential opportunities for further personalizing treatment for patients with prostate cancer."

P=NA | N=NA | "Veracyte, Inc...announced that new data published in European Urology Oncology suggest the Decipher Prostate Genomic Classifier could help identify prostate cancer patients who have micrometastatic disease (difficult-to-detect tumor cells that extend beyond the prostate) and who may therefore benefit from systemic treatment intensification....The researchers found that there was a significant correlation between patients’ Decipher Prostate scores and the risk of upstaging on PSMA PET, and that high Decipher scores were especially enriched in patients at the highest risk of harboring disease outside their prostate."

"Veracyte, Inc...announced today that seven abstracts highlighting new data from studies of the company’s Decipher urologic cancer tests will be presented at the American Urological Association (AUA) Annual Meeting, taking place April 28-May 1, 2023, at McCormick Place in Chicago. The abstracts include findings from two separate, large-scale studies that reinforce the real-world clinical utility of the company’s Decipher Prostate Genomic Classifier, which helps inform treatment decisions for men with prostate cancer."

"Veracyte...announced today that three abstracts highlighting the company’s unique, multi-omics capabilities and offerings for biopharmaceutical partners will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, Florida."

"US-headquartered startup C2i Genomics has announced a collaboration with Riken Genesis (RG) Co. to bring minimal residual disease (MRD) cancer monitoring to Japan for pharmaceutical and clinical research...Under this agreement, RG will work with C2i Genomics to commercialise its C2intelligence cloud-based platform and the C2inform MRD test for pharmaceutical and clinical research and eventually for commercial clinical testing in Japan."

"Veracyte...announced that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, 'The Red Journal') demonstrate that the company’s Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer. The data, from a pre-specified analysis of three phase 3 trials, represent the first validation of any gene-expression biomarker on pre-treatment biopsy samples from prospective randomized trials, and suggest the Decipher test provides clinically useful prognostic information to help personalize shared treatment decision-making."

"Veracyte...announced new data being presented this week at the 2023 American Society of Clinical Oncology Genitourinary (ASCO GU) Symposium which demonstrate that a gene expression signature derived from the company’s proprietary Decipher Genomics Resource for Intelligent Discovery (GRID) database may help physicians further personalize treatment for men with prostate cancer, based on their tumor’s molecular subtype. Additional data being presented at the meeting, taking place in San Francisco and online, February 16-18, reinforce the clinical utility of the company’s Decipher Prostate Genomic Classifier."

"Veracyte...announced that data published in Frontiers in Endocrinology provide new insights into the frequency and risk of malignancy (ROM) associated with thyroid stimulating hormone receptor (TSHR) mutations in indeterminate thyroid nodules. The findings, which were derived from analyses of Veracyte’s comprehensive thyroid nodule database of whole transcriptome sequencing, suggest that the use of Afirma testing could help inform diagnoses and personalized treatment decisions for patients with thyroid nodules."

"Veracyte, Inc...announced that six abstracts highlighting new data focused on the company’s Decipher urologic cancer testing offerings will be presented at the 2023 ASCO Genitourinary (GU) Cancers Symposium, taking place in San Francisco, Calif. and online, February 16-18, 2023. Data being presented include new insights derived from Veracyte’s Decipher Genomics Resource for Intelligent Discovery (GRID) database, which suggest potential opportunities to further personalize treatment for men with prostate cancer. Additionally, researchers will present new Decipher Prostate Genomic Classifier clinical utility data from the prospective, phase 3, randomized clinical trial, G-MINOR (Genomics in Michigan ImpactiNg Observation or Radiation)."

"AstraZeneca will evaluate C2i Genomics' whole-genome minimal residual disease assay and cancer-monitoring platform for use in clinical research and drug development efforts, the companies announced Thursday...The agreement is an extension of a previous collaboration in which the companies evaluated C2i Genomics' minimal residual disease (MRD) test across multiple solid cancers using artificially generated samples. The test was able to detect circulating tumor DNA (ctDNA), which was present at varying levels in the samples, down to 0.002 percent allelic frequency, the firms said."

"Veracyte...announced that findings demonstrating the strong real-world performance of the Afirma Genomic Sequencing Classifier (GSC) were published in The Journal of Clinical Endocrinology & Metabolism (JCEM). The data, from a meta-analysis of 13 independent studies, show that the Afirma GSC can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules (ITNs) and that, when the test identifies a nodule as suspicious, the patient’s risk of malignancy is consistent with, and higher than, that reported in the test’s original clinical validation (CV) study."

"Veracyte...announced today that three abstracts highlighting the company’s unique, multi-omics immuno-oncology capabilities and offerings will be presented at the Society for Immunotherapy of Cancer’s 37th Annual Meeting & Pre-Conference Programs (SITC 2022), taking place November 8-12, 2022, in Boston."

P3 | N=350 | NCT01272050 | "The new data shared at ASTRO show that the subset of men with higher PORTOS scores had substantial improvement in clinical-progression-free survival (CPFS) with the higher dose of SRT (70Gy). Specifically, those men with higher PORTOS scores had an absolute benefit of 45% CPFS at 5 years with dose-intensified SRT compared with the standard dose, while the men with lower PORTOS scores had an absolute benefit of -10% (p-interaction=0.003)....It is estimated that up to 40 percent of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen (PSA).1 For those men who experience a rising PSA, treatment with 64-72 Gy SRT is now standard of care, though treatment with higher doses can lead to greater urinary and bowel side effects."

"Veracyte, Inc...announced data that provide new insights into thyroid tumor behavior....They found that the top-performing signatures were able to stratify nodules as low-risk with a negative predictive value for no invasion or metastasis of 95% and 100%, respectively. Conversely, the highest-performing signatures had a positive predictive value of 57% for invasion and 41% for metastasis....Additional data presented at the ATA conference demonstrate the Afirma GSC’s ability to inform diagnosis and treatment decisions for patients with thyroid nodules. While thyroid stimulating hormone receptor (TSHR) mutations are mostly associated with benign thyroid nodules, researchers found that when the Afirma GSC identified a thyroid nodule with a TSHR mutation and a result that was 'suspicious' for cancer, the risk of malignancy was significantly higher at 15.3%, compared to those classified by the Afirma GSC as benign where the extrapolated risk is <1.5%."