Next Generation Sequencing (NGS) Tests Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2024 Update
Next Generation Sequencing (NGS) Tests Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2024 Update
Summary
GlobalData's Medical Devices sector report, “Next Generation Sequencing (NGS) Tests Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2024 Update provides comprehensive information about the Next Generation Sequencing (NGS) Tests pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.
Next generation sequencing (NGS) refers to high-throughput methods for DNA sequencing that are not Sanger-based. NGS technology has largely superseded Sanger sequencing in academic or genome research and is increasingly being applied in clinical practice.
Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.
Scope
Extensive coverage of the Next Generation Sequencing (NGS) Tests under development
The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
The report reviews the major players involved in the development of Next Generation Sequencing (NGS) Tests and list all their pipeline projects
The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
The report provides key clinical trial data of ongoing trials specific to pipeline products
Recent developments in the segment / industry
Reasons to Buy
The report enables you to -
Formulate significant competitor information, analysis, and insights to improve R&D strategies
Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage
Identify and understand important and diverse types of Next Generation Sequencing (NGS) Tests under development
Develop market-entry and market expansion strategies
Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
In-depth analysis of the product’s current stage of development, territory and estimated launch date
About GlobalData
Introduction
Next Generation Sequencing (NGS) Tests Overview
Products under Development
Next Generation Sequencing (NGS) Tests - Pipeline Products by Stage of Development
Table Figure 1: Next Generation Sequencing (NGS) Tests - Pipeline Products by Stage of Development
Table Next Generation Sequencing (NGS) Tests - Pipeline Products by Stage of Development
Next Generation Sequencing (NGS) Tests - Pipeline Products by Territory
Table Figure 2: Next Generation Sequencing (NGS) Tests - Pipeline Products by Territory
Table Next Generation Sequencing (NGS) Tests - Pipeline Products by Territory
Next Generation Sequencing (NGS) Tests - Pipeline Products by Regulatory Path
Table Figure 3: Next Generation Sequencing (NGS) Tests - Pipeline Products by Regulatory Path
Table Next Generation Sequencing (NGS) Tests - Pipeline Products by Regulatory Path
Next Generation Sequencing (NGS) Tests - Pipeline Products by Estimated Approval Date
Table Figure 4: Next Generation Sequencing (NGS) Tests - Pipeline Products by Estimated Approval Date
Table Next Generation Sequencing (NGS) Tests - Pipeline Products by Estimated Approval Date
Next Generation Sequencing (NGS) Tests - Ongoing Clinical Trials
Table OncoCompass Target CDx Test - Tepotinib - Product Status
Table OncoCompass Target CDx Test - Tepotinib - Product Description
Table OverC Multi-Cancer Detection Blood Test Kit - Product Status
Table OverC Multi-Cancer Detection Blood Test Kit - Product Description
Table Burning Rock Biotech Ltd - Ongoing Clinical Trials Overview
Table OverC Multi-Cancer Detection Blood Test Kit - A Prospective Multi-cancer Early-detection and Interventional Study in Asymptomatic Individuals: PREVENT
Table OverC Multi-Cancer Detection Blood Test Kit - A Prospective, Multicenter Study on Development and Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection (Pan-cancer Early Detection project, PREDICT Study)
Table OverC Multi-Cancer Detection Blood Test Kit - Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
Table OverC Multi-Cancer Detection Blood Test Kit - Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study
Table OverC Multi-Cancer Detection Blood Test Kit - Burning Rock Pan-cancer Early Detection Project (PREDICT): A Prospective, Multicenter Study to Develop and Validate the Performance of a Cfdna Methylation Based Model on Early Cancer Detection
Table OverC Multi-Cancer Detection Blood Test Kit - Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)
Table OverC Multi-Cancer Detection Blood Test Kit - Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
Table OverC Multi-Cancer Detection Blood Test Kit - Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: A Multi-center, Prospective Observational Study
Table CanScan MCED Kit - A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population
Genetron Health (Beijing) Co Ltd Company Overview
Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview
Table Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview
Table Blood-Based Lung EGFR NGS IVD Assay - Product Status
Table TruSight Oncology 500 HRD - Molecular Landscape Involved in the Onset of Breast Cancer in Patients With Germline BRCA-1/2 Mutations, During or After Therapy With Platinum-based Agents and/or PARP-inhibitors for Ovarian Cancer
Immunovia AB Company Overview
Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview
Table Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview
Table RaDaR Assay - Liquid Biopsy for Minimal Residual Disease Detection in Head and Necksquamous Cell Carcinoma (LIONESS) Study
Table RaDaR Assay - SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) - a Partially Double-blinded, Multi-center, Randomized, Controlled Superiority Study
Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview
Table Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview
Table xT-Onco Assay - Product Status
Table xT-Onco Assay - Product Description
Table Tempus Health Inc - Ongoing Clinical Trials Overview
Table xT-Onco Assay - A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
Tempus Labs Inc Company Overview
Tempus Labs Inc Pipeline Products & Ongoing Clinical Trials Overview
Table Oncomine Precision Assay - Non-Small Cell Lung Cancer - A Multi-center Observational Study to Evaluate the Clinical Utility of Returning Genomic Aberration Results Using the Oncomine Precision Assay in Advanced or Metastatic Nonsmall Cell Lung Cancer within the Exactis Network
Table Cell Free DNA Assay - Kidney Cancer - Product Status
Table Cell Free DNA Assay - Kidney Cancer - Product Description
Next Generation Sequencing (NGS) Tests- Recent Developments
May 03, 2024: Decisiondx-Scc Significantly Improves Prediction Accuracy of Metastatic Events after Mohs Surgery in New Study of Patients with High-Risk Cutaneous Squamous Cell Carcinoma Tumors of the Head and Neck
Apr 29, 2024: GenomOncology Introduces Expanded Support for Germline Testing in GO Pathology Workbench
Apr 24, 2024: TwinStrand Biosciences Initiates Regulatory Approval Process for Duplex Sequencing Mutagenesis Assays with OECD
Apr 23, 2024: Pillar Biosciences oncoReveal CDx pan-cancer solid tumor IVD now FDA approved for general tumor profiling on the Illumina MiSeq Dx System
Apr 11, 2024: German Gynecological Oncology Group (AGO) Recognizes BluePrint in Breast Cancer Guidelines
Apr 05, 2024: Predicine Introduces PredicineCARE NGS Kit for Global Clinical Trials, CDx Development and Patient Testing
Apr 04, 2024: Presentations at EADO Highlight Potential Impact of Castle Biosciences' DecisionDx- Melanoma and DecisionDx-SCC Tests on the Management of Patients with Skin Cancer
Mar 26, 2024: 10x Genomics Commercially Launches Visium HD Spatial Gene Expression Assay
Mar 21, 2024: Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date
Mar 19, 2024: Leading Squamous Cell Carcinoma Practitioners Publish Consensus Guidelines Integrating DecisionDx-SCC into a Clinical Workflow to Improve Decision-Making Regarding the Use of Adjuvant Radiation Therapy
Mar 19, 2024: Singular Genomics Systems Reports Results for the Quarter Ended in December – Earnings
Mar 08, 2024: Castle Biosciences to Present New Data Highlighting the Clinical Value of its Dermatologic Tests for Patients with Skin Cancer at the 2024 American Academy of Dermatology (AAD) Annual Meeting
Mar 08, 2024: Agendia Presents Data at Miami Breast 2024 Demonstrating MammaPrint + BluePrint's Ability to Further Stratify Tumor Categories in Hormone-Positive Breast Cancer, Highlighting Response to Different Chemotherapy Regimens
Mar 07, 2024: In Novel Cohort, New Data Confirms DecisionDx-SCC Provides Significant, Independent and Clinically Actionable Risk-Stratification of Patients, Including in Various High-Risk Subgroups
Feb 27, 2024: Natera Announces Next Phase of CareDx Patent Infringement Litigation Seeking Royalty For All Ongoing And Future AlloSure Tests
Feb 21, 2024: Tempus Expanding Access to its Next-Generation Sequencing Tests as an In-Network Provider for Cigna
Feb 06, 2024: Volta Labs and Integrated DNA Technologies Partner to Advance Target Enrichment Workflows
Jan 18, 2024: New Study Highlights Significant Potential Medicare Savings Through Use of Castle Biosciences' DecisionDx-SCC Test to Guide Adjuvant Radiation Therapy Decisions in Patients with Cutaneous Squamous Cell Carcinoma
Jan 18, 2024: Tempus launches MRD assay for colorectal cancer research
Jan 18, 2024: Quantum-Si Introduces World's First Next-Generation Protein Sequencer in Japan with Addition of New Distributor
Jan 17, 2024: Revolutionizing Drug Development: Novigenix Unveils AI-Powered RNA Analysis for Immune Response Profiling
Jan 16, 2024: Personalis Announces Medicare Coverage for NeXT Dx(R) Comprehensive Genomic Tumor Profiling Assay
Jan 14, 2024: Castle Biosciences Presents Data Supporting the Utility of Its Tests in the Clinical Care of Patients with Skin Cancers at the 2024 Winter Clinical Dermatology Conference – Hawaii
Jan 09, 2024: Myriad Genetics Applauds New Germline Testing Guideline for Patients with Breast Cancer from ASCO-SSO
Jan 09, 2024: Quest Diagnostics and Ultima Collaborate to Scale Ultima's Technology in Fast-Growing Minimal Residual Disease and Whole Genome Sequencing
Jan 08, 2024: Haystack Oncology and Alliance Foundation Trials collaborate to use Haystack MRD technology in phase II clinical trial for unresectable stage III NSCLC
Jan 04, 2024: Geneseeq scores FDA breakthrough designation for cancer detection device
Dec 27, 2023: Natera Wins Preliminary Injunction in Patent Infringement Lawsuit Against NeoGenomics' RaDaR Test
Dec 14, 2023: Haystack Oncology and Rutgers Cancer Institute Collaborate to use Haystack MRD in Clinical Study of Early-Stage Triple-Negative Breast Cancer
Dec 09, 2023: Adaptive Biotechnologies Announces New Data Highlighting the Clinical Relevance of MRD Testing with clonoSEQ in Patients with Blood Cancers at the 65th ASH Annual Meeting
Dec 05, 2023: Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Actionability of Clonoseq MRD Testing in Blood Cancer Patient Care and Drug Development at the 65th ASH Annual Meeting
Dec 05, 2023: NeoGenomics to Present New Data at San Antonio Breast Cancer Symposium Highlighting Utility of RaDaR for Therapy Response
Dec 01, 2023: Strata Oncology Announces Presentations on Proprietary Multivariate Biomarkers at North America Conference on Lung Cancer and San Antonio Breast Cancer Symposium
Nov 28, 2023: NGeneBio's Blood Cancer Diagnostic Panel Gets Permit in Thailand
Nov 20, 2023: U.S. FDA Approves FoundationOne CDx as a Companion Diagnostic for AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) to Identify Patients with HRPositive, HER2-Negative Advanced Breast Cancer
Nov 20, 2023: Roswell Park Launches Advanced, High-Speed Blood Cancer Test
Nov 15, 2023: Tempus Announces Medicare Coverage for Tempus|xT Across Solid Tumor and Hematologic Malignancies
Nov 14, 2023: Castle Biosciences Announces Multiple Data Presentations at the 2023 American Society for Dermatologic Surgery Annual Meeting
Nov 06, 2023: Invitae Launches Enhanced Chemistry of MRD Test to Better Serve Biopharmaceutical Clinical and Research Partnerships
Nov 06, 2023: NGeneBio Releases Upgraded NGS-Based Companion Diagnostics for Cancer
Oct 26, 2023: Foundation Medicine Announces Participation in National Cancer Institute's ComboMATCH Initiative to Connect Patients with New Anti-Cancer Drug Combinations
Oct 21, 2023: Foundation Medicine Expands Partnership With Sequanta to Provide Both Liquid and Tissue Genomic Profiling Services in China to Support Global Regulatory Filings
Oct 19, 2023: Foundation Medicine Announces Acceptance of 11 Abstracts at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting
Oct 18, 2023: New Data Highlights Clinical Utility and Performance of Castle Biosciences' Dermatologic Test Portfolio at the 2023 Fall Clinical Dermatology Conference
Oct 17, 2023: Predicine Announces Six Studies Showcasing Mrd and Liquid Biopsy Innovations at ESMO 2023
Oct 15, 2023: Burning Rock Received Breakthrough Device Designation from China's NMPA for its Multi-Cancer Early Detection Test
Oct 12, 2023: FDA Approves FoundationOneCDx and FoundationOnLiquid CDx as Companion Diagnostics for Pfizer's BRAFTOVI (encorafenib) in Combination With MEKTOVI (binimetinib) to Identify Patients with BRAF V600E Alterations in Metastatic NSCLC
Oct 10, 2023: Karius Test Improves the Diagnosis and Management of Pneumonia in Patients Undergoing Treatment for Blood Cancer
Oct 09, 2023: U.S. Food and Drug Administration (FDA) Approves FoundationOne CDx as a Companion Diagnostic for Lilly's Retevmo (selpercatinib) for Certain Patients with Solid Tumors
Oct 03, 2023: Castle Biosciences Presents New Data at ASTRO 2023 Highlighting Risk-Stratification Performance of Decisiondx-Scc in Patients With Cutaneous Squamous Cell Carcinoma Eligible for Adjuvant Radiation Therapy
Sep 28, 2023: New Neoadjuvant Trial Confirms the Predictive Utility of Mammaprint + Blueprint
Sep 20, 2023: 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
Sep 19, 2023: Pillar Biosciences Launches oncoReveal Core LBx, an NGS Kit to Enable Localized Liquid Biopsy Testing
Sep 19, 2023: Myriad Genetics and Illumina Achieve Milestones in Strategic Partnership to Support Biopharma Clinical Trials
Sep 07, 2023: Strata Oncology Announces New Data Supporting Utility of Immunotherapy Response Score to Guide First-Line Treatment Decisions in Non-small Cell Lung Cancer
Aug 22, 2023: New Study Shows UroAmp Can Detect Bladder Cancer Not Found by Cystoscopy or Urine Cytology
Aug 22, 2023: Myriad Genetics And Onsite Women's Health Partner To Help More Women Understand Breast Cancer Risk
Aug 22, 2023: Geneseeq Gains CE Marks For NGS-based Test Kits For Solid Tumors And Hematological Cancer
Aug 21, 2023: Scale Biosciences And Basepair To Democratize Single Cell Sequencing Data Analysis
Aug 16, 2023: 4BASES Announces the Readiness of a CFTR Mutations Detection Solution
Aug 14, 2023: U.S. Food and Drug Administration (FDA) Approves FoundationOne CDx as a Companion Diagnostic for Janssen's AKEEGA (niraparib and abiraterone acetate Dual Action Tablet) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Aug 02, 2023: Karius Test, a Liquid Biopsy for Infectious Diseases, Incorporated into Diagnostics Recommendation in the 2023 Duke-ISCVID Criteria for Infective Endocarditis
Jul 27, 2023: NeoGenomics Announces Medicare Coverage for RaDaR Assay for Minimal Residual Disease and Recurrence in Breast Cancer
Jul 24, 2023: Myriad Genetics Announces Inclusion of Breast Density to MyRisk with RiskScore Breast Cancer Risk Assessment
Jul 12, 2023: Tempus Announces the GEMINI Non-Small Cell Lung Cancer Study
Jun 30, 2023: Novigenix Reports Interim European Validation Data on Its New NGS-Based Whole Blood RNA Signature for Detection of Advanced Colorectal Adenomas
Jun 15, 2023: Neogenomics' RaDaR Assay for Minimal Residual Disease Receives First Commercial Coverage
Jun 12, 2023: FDA approves FoundationOne Liquid CDx as companion diagnostic for Braftovi
Jun 12, 2023: Castle Biosciences Presents New Data Demonstrating the Ability of Decisiondx-SCC to Identify Tumors Likely to Metastasize in Patients With Cutaneous Squamous Cell Carcinoma Deemed Low Risk by Traditional Staging
Jun 08, 2023: Burning Rock's Precision Oncology Diagnostics Product Supports Advancement in Late- Stage Breast Cancer Treatment, With Results Published in the New England Journal of Medicine
Jun 08, 2023: Imbdx Expands Targeted Therapies Agreement Following Successful Evaluation of Blood-Based Genomic Profiling Assay in Prostate Cancer
Jun 08, 2023: Published in the New England Journal of Medicine
Jun 05, 2023: Framework incorporating DecisionDx-SCC test results into clinical decision-making for patients with high-risk cutaneous squamous cell carcinoma published in Clinical, Cosmetic and Investigational Dermatology
Jun 05, 2023: NeoGenomics and German Breast Group Announce New Data Demonstrating Clinical Potential of the RaDaR MRD Assay in HR+/HER2- Breast Cancer
Jun 02, 2023: Adaptive Biotechnologies highlights new data at ASCO 2023 and EHA 2023 underscoring the clonoSEQ assay's Impact as a Standard for Minimal Residual Disease Assessment in Patients with Hematologic Cancer
Jun 01, 2023: Labcorp introduces new liquid biopsy test
May 31, 2023: Agendia studies reveal the influence of race on a tumor's biology, reinforcing its commitment to advancing research of racial disparities in breast cancer
May 30, 2023: NeoGenomics to showcase the transformational impact of RaDaR assay for molecular residual disease and recurrence monitoring at ASCO
May 25, 2023: Digi7 launches Geneyx AI-based solution to analyse next-generation sequencing data at Mediclinic
May 23, 2023: Tempus Labs receives CLIA approval for xT CDx Test