COMPANY:

Predicine

"Predicine, Inc....is pleased to announce the publication of a landmark study in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of the PredicineCARE™ liquid biopsy assay, which enabled identification and enrollment of PIK3CA-positive patients in China. The trial targets patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer (mBC)."

"Predicine, Inc...announced today that it will present data from 9 ctDNA studies at ASCO 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and drug resistance mechanism studies. The forthcoming data represents significant potential for the practical application of Predicine’s cutting-edge liquid biopsy technology in personalized cancer care, clinical trials, and Companion Diagnostic (CDx) development."

"Predicine, Inc...announced the release of its innovative PredicineCARE™ NGS Kit. This offering presents a research-use-only (RUO) next-generation sequencing (NGS) kit packaged for genomic profiling across various cancers, enabling tumor profiling."

"Predicine, Inc...today announced a collaboration with Apollomics, Inc. This collaboration aims to advance the development of PredicineCARE, a blood cell-free DNA (cfDNA) next-generation sequencing (NGS) assay, to identify non-small cell lung cancer (NSCLC) patients who may benefit from targeted therapy."

"Predicine...announced today that it will present data from 15 ctDNA studies at AACR 2024, spotlighting the clinical utility of Predicine’s genomic and epigenomic liquid biopsy solutions for patient selection, disease monitoring, and disease mechanism studies."

"Predicine...announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company. This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy....PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and gene deletions in key cancer-associated genes using cfDNA in urine."

P1 | N=498 | NCT04449874 | Sponsor: Genentech, Inc. | "Consistent with the outcomes of the prior Phase 1 clinical trial, PredicineBEACON showcased remarkable biomarker results in the Phase 1b clinical trial of Divarasib Plus Cetuximab in CRC patients. A decline in KARAS G12C variant allele frequency was associated with treatment response, observed as early as CID15 in responsive patients. Using baseline, on-treatment, and end-of-treatment plasma samples, out of the 14 patients profiled, 13 (92.9%) exhibited at least one acquired genomic alteration linked with treatment resistance. The enhanced antitumor activity observed in this study reinforces the clinical utility of liquid biopsy profiling in evaluating the Phase 1b clinical trial of combined therapy in CRC patients."

"Predicine...announce its participation in the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain. The company will present six compelling poster studies, unveiling the future of liquid biopsy solutions...These poster presentations will shine a spotlight on Predicine’s groundbreaking liquid biopsy innovations, including PredicineBEACON™, a revolutionary solution for personalized and actionable minimal residual disease (MRD) analysis."

"Predicine, Inc...announced a new study published in The New England Journal of Medicine (NEJM), demonstrating the clinical utility of its minimal residual disease (MRD) Liquid Biopsy Assay in support of Genentech's Phase 1 Clinical Trial of Divarasib. This milestone reaffirms Predicine's position as a leader in the field of liquid biopsy diagnostics....These findings underscore the clinical utility of liquid biopsy profiling in the assessment of phase I clinical trial of Divarasib."

"Predicine...announced...that it will present two studies and introduce PredicineALERT™ Minimal Residual Disease (MRD) liquid biopsy assay to genitourinary (GU) cancers at the 2023 American Urological Association (AUA) Annual Meeting held in Chicago between April 28 to May 1, 2023...PredicineALERT™ provides a tumor-naive approach to MRD testing for GU cancers. Key highlights include methylation-based MRD detection without the need of personalization, fast turn-around-time (TAT) down to 6 days, and low sample input using 2.5ng of cfDNA."

"Predicine...announced today that it will present data from 12 studies and introduce PredicineALERT™, a next-generation Minimal Residual Disease (MRD) liquid biopsy assay at the 2023 AACR Conference on April 14-19, 2023....Key highlights of the PredicineALERT™ MRD assay include: (i) Tumor-naive MRD detection without the need of personalization; (ii) Fast turn-around-time (TAT) down to 6 days; (iii) Sample input using as low as 2.5ng cell-free DNA. Predicine will also present twelve posters demonstrating the clinical utility and effectiveness of Predicine’s liquid biopsy platform across a multitude of indications, clinical trials, and profiling applications."

"Predicine will present four posters at the ASCO Genitourinary Cancers Symposium, February 16-18, 2023, highlighting the technical and clinical utility of Predicine’s suite of liquid based comprehensive genomic solutions in bladder, prostate tumors...The posters to be presented include:...Evaluating the technical feasibility of a urine cell-free DNA (cfDNA) NGS assay for identifying biomarkers in bladder cancer – Poster BD# N8 (collaboration with Janssen Pharmaceuticals)..."

"Predicine...announces the introduction of PredicineCOMPLETE™, the organization’s most comprehensive next-generation liquid biopsy solution that provides genome-wide, genomic and epigenomic insights to capture the mutational landscape and the immune signature of cancer and to help support cancer research and clinical drug development."

"Predicine, Inc...announced...that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the PredicineCARE cfDNA Assay, a Next-Generation Sequencing (NGS) assay for tumor mutation profiling in cfDNA isolated from liquid biopsy samples from cancer patients."

"Predicine, Inc.,.announced...that it will present four posters at the ESMO conference being held September 9-13, 2022, in Paris, France...Predicine is delighted to present at the ESMO conference and to introduce the full suite of liquid biopsy solutions, highlighting the PredicineATLAS 600 gene assay, PredicineBEACON personalized MRD assay, PredicineCNB assay for longitudinal Copy Number Burden assessment, and PredicineEPIC methylation assay."

"Predicine, Inc...has launched its CE-marked PredicineCARE™ for genomic profiling in blood and urine. The PredicineCARE cell free DNA (cfDNA) assay is a targeted Next-Generation Sequencing (NGS) assay for the detection of single nucleotide variants (SNVs), insertions and deletions (Indels), DNA re-arrangements (fusions) and copy number variations (CNVs) in patients diagnosed with cancer."

"Predicine...announced the results of a new research study that demonstrated superior performance of the PredicineATLAS™ liquid biopsy next-generation sequencing (NGS) assay compared to four other leading liquid biopsy assays for key metrics. The manuscript, 'Direct comparison of circulating tumor DNA sequencing assays with targeted large gene panels,' was released online ahead of publication in PLOS ONE."

"Predicine...announced today that it will highlight the clinical utility of its full suite of genomic profiling solutions at the 2022 AACR conference being held April 8-13, 2022, in New Orleans...Key highlights include: The launch of PredicineBEACON™ a tissue-agnostic, actionable minimal residual disease (MRD) detection platform...Urine, blood, and tissue based NGS solutions that address the full continuum of cancer patient care, from early cancer detection to diagnosis and therapy selection, to therapy monitoring and MRD."

"Predicine...announced...that it will present six posters highlighting clinical utility of Predicine's full suite of liquid- and tissue-based comprehensive genomic profiling solutions at the ASCO Genitourinary Cancers Symposium being held February 17-19, 2022, in San Francisco....The posters are focused on the full spectrum of GU indications, including muscle invasive bladder cancer (MIBC), metastatic castration-resistant prostate cancer (mCRPC), renal cell carcinoma (RCC) and locally advanced and metastatic Upper Tract Urothelial Carcinomas (UTUC)."