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COMPANY:
Predicine

i
Other names: Predicine | Huidu Medical Shanghai | Huidu Shanghai Medical Sciences
Related tests:
Evidence

News

3ms
Predicine Announces Collaboration with Janssen to Develop PredicineCARE as a Companion Diagnostic Assay in Localized Bladder Cancer (GlobeNewswire)
"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."
Licensing / partnership
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PredicineCARE™
4ms
Nature Medicine Study Validates PredicineBEACON MRD Liquid Biopsy Assay in Genentech’s Phase 1b Clinical Trial of Divarasib Plus Cetuximab in CRC (GlobeNewswire)
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."
P1 data
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PredicineBEACON™
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divarasib (RG6330)
5ms
Predicine announces six studies showcasing MRD and liquid biopsy innovations at ESMO 2023 (GlobeNewswire)
"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."
Real-world evidence • Clinical data
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PredicineBEACON™ • PredicineCARE™ • PredicineWES+™
6ms
Predicine Announces New Study Published in The New England Journal of Medicine Demonstrating Clinical Utility of its MRD Liquid Biopsy Assay in Supporting Genentech’s Phase 1 Clinical Trial of Divarasib (GlobeNewswire)
"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."
P1 data
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PredicineBEACON™ • PredicineWES+™
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divarasib (RG6330)
11ms
Predicine to introduce PredicineALERT™ MRD assay and present two ctDNA studies in genitourinary cancers at AUA 2023 Annual Meeting (Predicine Press Release)
"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."
Clinical data
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PredicineALERT™
12ms
Predicine to Introduce PredicineALERT MRD Assay and Present Twelve Posters at AACR 2023 Conference (GlobeNewswire)
"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."
Clinical data
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PredicineALERT™
1year
Predicine to present four studies at 2023 ASCO Genitourinary (GU) Symposium highlighting the technical and clinical utility of Predicine’s liquid biopsy based assays (Predicine Press Release)
"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)..."
Clinical data
over1year
Predicine to introduce PredicineCOMPLETE™, its genome-wide liquid biopsy solution at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting (Predicine Press Release)
"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."
Clinical
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PredicineCOMPLETE™
over1year
Predicine’s liquid biopsy Next-Generation Sequencing (NGS) assay is granted Breakthrough Device Designation by U.S. Food and Drug Administration (Predicine Press Release)
"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."
FDA event
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PredicineCARE™
over1year
Predicine to present new data at ESMO 2022 demonstrating the utility of its portfolio of liquid biopsy tests for cancer patients (Predicine Press Release)
"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."
Clinical data
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PredicineATLAS™ • PredicineBEACON™
over1year
Predicine expands to Europe with the recently launched CE-Marked cfDNA Assay PredicineCARE™ for genomic profiling in blood and urine (Predicine Press Release)
"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."
Launch • European regulatory
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PredicineCARE™
almost2years
Predicine liquid biopsy outperforms four other leading ctDNA NGS tests in a study by Bristol Myers Squibb (PRNewswire)
"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."
Clinical data
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PredicineATLAS™
almost2years
Predicine to attend 2022 AACR conference in New Orleans to highlight the launch of PredicineBEACON™, a novel, tissue-agnostic, actionable assay for minimal residual disease (MRD) detection and the recent publication of several studies in genitourinary (GU) cancers (PRNewswire)
"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."
Launch • P2 data
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PredicineBEACON™
2years
Predicine to Present Six Studies, including the Demonstrating the Clinical Utility of Its PredicineBEACON, a Tissue-agnostic MRD Liquid Biopsy Solution, in Genitourinary (GU) Cancers at 2022 ASCO-GU Annual Conference (PRNewswire)
"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)."
Clinical
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PredicineBEACON™