COMPANY:

Veracyte

"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."

"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)."

"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%."

"Veracyte...announced that two abstracts highlighting the clinical value of the company’s Envisia Genomic Classifier and Percepta Nasal Swab tests in interstitial lung disease (ILD) and lung cancer, respectively, were presented as posters today at the American College of Chest Physicians (CHEST) Annual Meeting 2022, taking place in Nashville, Tenn., October 16-19."

"Veracyte...announced that data published today in the Journal of the National Cancer Institute demonstrate that the company’s Decipher Prostate Genomic Classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease. The data, from the prospective, multi-site VANDAAM Phase 2 clinical study, suggest that the genomic test may offer a robust improvement over clinical factors alone in risk-stratifying prostate cancer among African American men, which may help reduce disparities in prostate cancer outcomes."

P2/3 | N=12200 | STAMPEDE (NCT00268476) | "The Decipher Prostate classifier is a 22-gene prognostic biomarker that provides a score that indicates the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment....In a poster presentation today (Abstract #1381P), researchers shared data showing that the Decipher GRID androgen receptor activity (AR-A) signature is prognostic for outcomes in men with castration-sensitive prostate cancer (CSPC) that has spread to no more than three other sites in the body (oligometastatic CSPC, or omCSPC). The researchers concluded that the GRID AR-A signature is prognostic for outcomes in men with omCSPC treated with metastasis-directed therapy (MDT, or radiotherapy) and that patients with a low AR-A score receive the most benefit from the addition of ADT to MDT."

"Veracyte, Inc...announced today that seven abstracts showcasing the company’s genomic tests for prostate (Decipher) and breast (Prosigna) cancers will be presented at the European Society for Medical Oncology (ESMO) Congress 2022, taking place September 9-13, 2022, in Paris....'We are particularly excited about new data from a post-hoc analysis that evaluated the clinical performance of our Decipher Prostate test in one arm of the large, multi-center, randomized STAMPEDE trial. We believe these data may help expand the Decipher test’s availability to advanced prostate cancer patients in the United States, and also support our plans to offer the Decipher Prostate test as an IVD on the nCounter Analysis System for use outside of the United States where laboratories can perform it locally'."

"Veracyte...announced that new clinical validation data published online in Thyroid show that the company’s RNA sequencing-based Afirma Medullary Thyroid Cancer (MTC) Classifier demonstrated high sensitivity and specificity in identifying MTC among pre-operative thyroid nodule fine needle aspiration (FNA) biopsy samples. The findings suggest that the genomic test may enable more timely diagnosis of this rare but aggressive form of thyroid cancer, compared to traditional methods, thus potentially expediting time to appropriate treatment."

"Veracyte, Inc...announced that new data published today in PLOS ONE show that the company’s Percepta Genomic Sequencing Classifier (GSC) is highly accurate in re-classifying lung cancer risk among patients with lung nodules whose bronchoscopy results are inconclusive. The authors also conclude that, based on findings from the large, multi-cohort study, use of the genomic test could enable a significant portion of patients to avoid unnecessary and invasive diagnostic procedures and offer the potential for earlier diagnosis."

P=NA | N=NA | "Veracyte, Inc...announced that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study....In the new meta-analysis, researchers evaluated 13 independent studies and found that the Afirma GSC’s real-world ability to identify benign nodules with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, respectively)."

"Veracyte, Inc...announced the publication of data reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy (RP). The findings, from an ancillary study of the prospective open-label, multicenter, randomized phase 3 SAKK 09/10 trial conducted at 28 centers in Belgium, Germany, and Switzerland, appear in Annals of Oncology."

P2 | N=201 | AtezoTRIBE (NCT03721653) | "Veracyte...announced today that new data published online in The Lancet Oncology suggest that the company’s Immunoscore Immune Checkpoint (IC) assay may identify patients with metastatic colorectal cancer (mCRC) who are likely to benefit from the addition of immune checkpoint inhibitor (ICI) therapy to standard first-line treatment. The findings are from the randomized, controlled, phase II AtezoTRIBE trial, a multicenter Italian clinical study, sponsored by GONO Foundation. The vast majority of mCRC tumors (approximately 95 percent) have a proficient DNA mismatch repair (pMMR) system and are microsatellite stable. These tumors have low immunogenicity and do not derive benefit from immune checkpoint inhibitors."

"Veracyte...announced today new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT."

"Veracyte...announced that new data from a large, population-based study reinforce the clinical utility of the Decipher Prostate genomic classifier. The findings, which will be shared for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, suggest that the Decipher Prostate tests are helping to guide prostate cancer treatment decisions and improve patient care."

"Veracyte, Inc. (Nasdaq: VCYT) announced today new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT....Within the two cohorts, all patients (100 percent) with a 'high-risk' Immunoscore IC result relapsed in less than 18 months. In contrast, 34 percent and 33 percent of patients with a 'low-risk' Immunoscore IC result did not relapse for a period of at least 36 months, in each cohort....'Further, we believe the test’s use could help enable patients who are unlikely to respond to ICIs to enter into novel, combination-immunotherapy trials'."

"Veracyte...announced new data showing that its Percepta Nasal Swab test accurately assesses lung cancer risk among current and former smokers with lung nodules, regardless of their smoking history burden and whether they are considered high risk for lung cancer based on U.S. Preventive Services Task Force (USPSTF) screening criteria. The findings were presented today at the American Thoracic Society 2022 International Conference (ATS 2022), being held in San Francisco."

"Veracyte...announced today that an updated clinical guideline from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO) includes a new statement that is favorable for genomic testing, including the Decipher Prostate genomic classifier, to help guide care for men with localized prostate cancer. The guideline authors specifically cite extensive evidence, including from multiple phase 3 randomized clinical trials, which have previously demonstrated that the Decipher Prostate genomic risk score is strongly associated with important prostate cancer-specific and oncologic outcomes."

"Veracyte, Inc....will be shared at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place in person and virtually from June 3-7, in Chicago."

"Veracyte, Inc...announced today that new consensus data from a survey of leading breast cancer oncologists in Europe suggest the importance of gene expression profile (GEP) testing in guiding treatment decisions for women with early-stage breast cancer. The findings, from the PROCURE study, were presented today at the European Society of Medical Oncology (ESMO) Breast Cancer 2022, taking place May 3-5 in Berlin, Germany...The PROCURE study utilized Delphi methodology to generate consensus regarding the clinical utility of GEP tests, including Veracyte’s Prosigna Breast Cancer Assay, in breast cancer treatment."

"Veracyte, Inc...announced today that three abstracts highlighting new data on the genomic underpinnings of prostate and bladder cancers will be presented at the American Urological Association Annual Meeting, taking place May 13-16, 2022, in New Orleans. The findings are derived from analyses of the Decipher GRID, a database that contains genomic profiling information from clinical samples used in the development and commercial application of the Decipher Prostate and Decipher Bladder tests."

"Veracyte, Inc...announced...that new, expanded data demonstrating the performance of the company’s non-invasive Percepta Nasal Swab test in the evaluation of potentially cancerous lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference. The meeting will take place May 13-18, 2022, in San Francisco."

"Veracyte, Inc...announced that new data validating the clinical utility of the company’s Decipher Prostate Genomic Classifier for guiding treatment selection in men with intermediate-risk prostate cancer will be presented Thursday, February 17, at the 2022 American Society of Clinical Oncology Genitourinary (ASCO GU) Symposium (Poster #M1). The data, from the randomized, Phase 3 NRG/RTOG 0126 study, confirm initial findings that the Decipher Prostate Genomic Classifier is a prognostic biomarker that can help physicians and patients make personalized treatment decisions in the intermediate-risk setting."

"Veracyte, Inc...announced that six abstracts highlighting new data for the company’s Decipher urologic cancer tests will be presented at the 2022 ASCO Genitourinary (GU) Cancers Symposium, taking place in San Francisco, Calif., and virtually, February 17-19, 2022...The accepted abstracts include data from a phase 3 study evaluating the Decipher genomic classifier as a prognostic biomarker for patients diagnosed with intermediate-risk prostate cancer from their diagnostic biopsy specimen. This is the first late-stage clinical study validating the use of any gene expression classifier as a prognostic biomarker in this setting."

"Veracyte, Inc...announced the publication of new data that suggest the company’s Percepta Genomic Sequencing Classifier (GSC) can accelerate delivery of curative therapy for patients with high-risk lung nodules and inconclusive bronchoscopy results. The findings, from a prospective, randomized decision impact study published in BMC Pulmonary Medicine, also show that the test can increase physician confidence in clinical decision-making and decrease unnecessary diagnostic procedures."

"Veracyte, Inc...announced that the Swedish Medical Technologies Product (MTP) Council has recommended the Prosigna Breast Cancer Assay for immediate reimbursement and clinical use in all Swedish healthcare regions without legal restrictions beginning November 22, 2021. The milestone follows recent G-BA reimbursement approval in Germany and underscores the test’s continued reimbursement momentum in the European Union."

N=450; PIONeeR (NCT03493581); “The posters include new data regarding the use of Brightplex TCE (for T Cells Exhaustion) to stratify non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors in the ‘Biomarker analysis’ part of the PIONeeR project….New findings on a preliminary PIONeeR patient data set suggest that one of those tests, the Brightplex TCE assay, can stratify NSCLC patients eligible for anti-PD-1/PD-L1 therapy into four Spatial Tumor-infiltrating lymphocyte (TILs)….In the Hot subtype, for example, long-term progression-free survival (PFS) is observed for more than 40% of patients, regardless of PD-L1 status. In this Hot subtype, activated T-cell densities seem higher in tumors of patients with longer PFS, suggesting that immune-response evaluation with the Brightplex TCE assay could refine the stratification of patients, enriching responders to immune checkpoint inhibitor therapy.”

"Veracyte...announced today the publication of new long-term clinical utility data showing that the company’s Afirma Genomic Sequencing Classifier (GSC) helped reduce unnecessary surgeries in patients with indeterminate thyroid nodule cytology, as compared to the use of no molecular testing. The peer-reviewed paper appears online in The Journal of the Endocrine Society...The Afirma GSC helps physicians identify patients with benign thyroid nodules from among those with indeterminate FNA results, so that they may avoid unnecessary thyroid surgery."

"Veracyte...announced that three abstracts highlighting the company’s immuno-oncology offerings for biopharmaceutical researchers will be presented at the Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting, taking place in Washington, DC and virtually, November 10-14, 2021...Poster Title: 'Spatial distribution of infiltrating T lymphocytes with Immunoscore® CR T Cells Exhaustion test helps stratification of NSCLC patients treated with PD1/L1 inhibitors in the PIONeeR project'."

"Veracyte, Inc...announced that its Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO1 Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer. The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021...The Immunoscore Colon Cancer test was included in the 2020 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients."

"Veracyte, Inc...announced today that new data being presented at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting suggest the company’s Decipher Prostate genomic classifier identifies patients with clinically high-risk prostate cancer who may require treatment intensification beyond standard-of-care therapy. The findings, from a pre-specified analysis of biopsy samples taken from prostate cancer patients with clinically high-risk disease who were enrolled in multiple phase 3, prospective, randomized studies, show that Decipher Prostate test scores are independently associated with distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS) in this patient population. After a median follow up of 11 years, men with disease classified as Decipher high-risk experienced substantially less favorable outcomes compared to men with disease classified as Decipher low-risk."

"Veracyte, Inc...announced that new data further validating the clinical utility of the company’s Decipher Prostate genomic test will be presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2021 taking place October 24-27, 2021, in Chicago. In two, separate oral presentations, investigators will share findings from studies that assessed the Decipher Prostate test in multiple, large Phase 3 randomized trials. The studies evaluated the test’s utility in patients with newly diagnosed, clinically high-risk prostate cancer receiving definitive radiotherapy as well as among patients experiencing biochemical disease progression following radical prostatectomy."

"Veracyte, Inc., (Nasdaq: VCYT) announced today the publication of new data demonstrating that the company’s Decipher Bladder genomic classifier accurately identifies bladder tumors that are most likely to respond to chemotherapy prior to radical cystectomy. These findings could ultimately help physicians optimize treatment planning for their patients with bladder cancer based on their tumor subtype biology. The peer-reviewed paper appears online today in The Journal of Urology."

"Veracyte, Inc...announced that four abstracts highlighting the clinical impact of the company’s genomic diagnostic tests for lung cancer...will be presented at the American College of Chest Physicians (CHEST) Annual Meeting 2021, being held virtually October 17-20, 2021."

"Veracyte...announced that its Decipher® Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer. The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed....The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01."

"Veracyte, Inc...announced the company has completed its acquisition of HalioDx to solidify its reach into global markets while expanding its scientific capabilities and diagnostics scope into 8 of the 10 top cancers as defined by U.S. incidence...HalioDx has become a wholly-owned subsidiary of Veracyte."

"Veracyte, Inc...announced new data suggesting the Decipher® Prostate Biopsy genomic classifier (GC) may help guide treatment decisions for prostate cancer patients who are candidates for active surveillance (AS). The findings, from a retrospective analysis of data from the MUSIC registry, appear online in the journal Prostate Cancer and Prostatic Diseases (PCAN). They provide the first evidence that Decipher scores predict time to definitive treatment and time to treatment failure among men with early-stage prostate cancer."