COMPANY:

Predicine

"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)."

"Predicine, Inc. announces results from a liquid biopsy study demonstrating the clinical application of utilizing the PredicineCARE™ liquid biopsy NGS assay to detect somatic mutations and copy number variations (CNVs) in women with metastatic breast cancer at the time of diagnosis and the time of disease progression...The study is entitled 'Mutational patters across breast cancer subtypes during metastatic disease progression'... This study demonstrates the value of utilizing PredicineCARE at the time of diagnosis and progression in women with metastatic breast cancer as the results can lead to tailored treatments to help extend survival."

"Higher preoperative utDNA or tDNA abundance correlated with worse relapse-free survival. Actionable variants including FGFR3 alteration and ERBB2 amplification were identified in utDNA...Urine-based molecular pathology provides a valid and complete genetic profile of bladder cancer, and represents a faithful surrogate for genotyping and monitoring newly diagnosed UBC."

"Predicine, Inc. announces results from a study demonstrating the concordance between their tissue and blood-based liquid biopsy assays, and the clinical application of utilizing the PredicineATLAS liquid biopsy NGS assay to detect somatic mutations and tumor mutation burden (TMB) in patients with metastatic urothelial carcinoma (mUC)...The study is entitled 'Longitudinal circulating tumor DNA profiling of metastatic urothelial carcinoma in the open-label Phase II POLARIS-03 trial'...demonstrates the clinical value of utilizing PredicineATLAS to assess somatic mutations and TMB in patients with metastatic urothelial cancer."

"Predicine, Inc. today announced results from a prostate cancer liquid biopsy study evaluating the landscape of genomic alterations in 231 patients with metastatic castration-resistant prostate cancer (mCRPC) from US and Australian cohorts. The study demonstrated the robust sensitivity and clinical utility of Predicine’s cfDNA liquid biopsy assay for detecting CNVs in the PTEN-PI3K-AKT pathway in mCRPC patients. It also found that concurrent CNVs in the PTEN-PI3K-AKT and AR pathways portend poor survival, and identifying this high-risk patient subset for dual AR/Akt inhibition may optimize precision treatment with Akt inhibitors."

"Huidu Medical has successfully completed the capacity assessment of the LUNG CANCER (NSCLC) Variant 1A project initiated by the European Molecular Genetics Quality Network (EMQN) in 2021...EMQN's Lung Cancer project capability assessment is designed to evaluate the ability and quality of participating clinical testing laboratories to detect non-small cell lung cancer (NSCLC) clinical targeted therapy-related gene mutations. It is mainly aimed at detecting the ability of BRAF, KRAS and other gene mutations that are highly related to lung cancer, and prompting relevant clinical recommendations."

"Huidu Medical’s Shanghai NGS Laboratory...passed the College of American Pathologists (CAP) high-throughput sequencing plasma free DNA (Cell-Free DNA, cfDNA) with a full score. Ability Test (PT)!...The cfDNA project is a verification project specifically used to evaluate the ability of global genetic diagnosis laboratories to detect and analyze genetic mutations based on liquid biopsy technology. The assessment indicators of this evaluation project include common tumor driver genes such as BRAF, EGFR, IDH1, KRAS, NRAS, etc."