Next Generation Sequencing (NGS) Tests Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2023 Update
Next Generation Sequencing (NGS) Tests Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2023 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, 2023 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 NGS technology has largely superseded Sanger sequencing in academic or genome research and is increasingly being applied in clinical practice.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 Artificial Intelligence Based Companion Diagnostics - Colorectal Cancer - Prevention of Colorectal Cancer Through Multiomics Blood Testing
Table Artificial Intelligence Based Companion Diagnostics - Colorectal Cancer - The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening
Table TruSight Oncology Comprehensive - A Study to Examine the Clinical Value of Comprehensive Genomic Profiling Performed by Belgian NGS Laboratories: a Belgian Precision Study of the BSMO in Collaboration With the Cancer Centre - Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT)
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
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
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 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
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 13, 2023: Geneseeq Receives Chinese NMPA Approval for Lung Cancer Tumor Mutational Burden NGS Test Kit
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
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
Jul 04, 2023: China's NMPA approves LAMH's liver cancer detection test
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 26, 2023: Foundation Medicine and its collaborators announce acceptance of 21 Abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
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
May 11, 2023: Tempus Labs obtains Pre-Market Approval (PMA) for xT CDx Test
May 02, 2023: Tempus receives FDA approval for NGS-based test xT CDx
Apr 28, 2023: Predicine to introduce PredicineALERT MRD Assay and present two ctDNA studies in genitourinary cancers at AUA 2023 Annual Meeting
Apr 25, 2023: Strata Oncology announces launch and medicare coverage for Strata Select, a first-ofits- kind immunotherapy test
Apr 25, 2023: New Studies on Convergent Genomics' Urine Test for Bladder Cancer to be Presented at 2023 American Urological Association (AUA) Annual Meeting
Apr 18, 2023: Myriad Genetics and Intermountain Precision Genomics now offer solid tumor testing in all 50 States with latest NY State Certification
Apr 17, 2023: Thermo Fisher Scientific Announces Oncomine Clinical Research Grant Awardees and Opens Spring 2023 Submissions
Apr 13, 2023: Myriad Genetics and SimonMed team up for genetic cancer risk programme
Apr 06, 2023: NeoGenomics to share nine abstracts at the American Association of Cancer Research (AACR) Annual Meeting 2023
Apr 03, 2023: Tempus announces second sequencing collaboration with Lilly to expand patient access to genomic testing
Mar 18, 2023: Late-Breaking data presented at the 2023 AAD Annual Meeting Demonstrates Improved Accuracy of DecisionDx-SCC in predicting metastatic risk over traditional staging systems in independent, multi-center cohort study
Mar 16, 2023: NeoGenomics announces commercial availability of the RaDaR Molecular Residual Disease Test
Mar 14, 2023: The Future Of Cancer Care: Next-Generation Sequencing Available at Cooperman Barnabas Medical Center
Mar 10, 2023: Castle Biosciences to highlight clinical value of its skin cancer tests at the 2023 American Academy of Dermatology (AAD) Annual Meeting
Mar 06, 2023: Freenome presents a subject population analysis of a clinical study using a multiomics blood test for the early detection of colorectal cancer
Mar 02, 2023: Point32Health and Foundation Medicine expand access to comprehensive genomic profiling for members with advanced cancer
Mar 02, 2023: Illumina and Myriad Genetics expand partnership to broaden access to HRD testing in the United States
Feb 22, 2023: SeqOne's new clinically validated HRD test reduces number of inconclusive results to improve the prescription of targeted treatments for ovarian cancer patients
Feb 21, 2023: iGene Laboratory announces launch of whole exome sequencing service
Feb 09, 2023: UnitedHealthcare provides commercial coverage for FoundationOne CDx and FoundationOne Liquid CDx in multiple companion diagnostic indications
Feb 07, 2023: Exact Sciences launches OncoExTra cancer therapy selection test in the U.S.
Feb 06, 2023: RaDaR(R) assay demonstrates clinical potential for helping Oncologists determine whether or not muscle-invasive bladder cancer patients undergo radical surgery
Jan 24, 2023: ACT Genomics receives CLIA approval for ACTOnco IVD Test
Jan 24, 2023: ACT Genomics receives CLIA approval for ACTOnco Test
Jan 10, 2023: Prenetics owned ACT Genomics receives FDA clearance for ACTOnco, the first Asiabased company to receive clearance for a comprehensive genomic profiling test for all solid tumors
Jan 03, 2023: ACT Genomics receives 510(k) clearance for ACTOnco IVD Test
Jan 03, 2023: ACT Genomics receives 510(k) clearance for ACTOnco Test
Dec 21, 2022: Foundation Medicine receives FDA approval for FoundationOneLiquid CDx as a companion diagnostic for a certain group of tyrosine kinase inhibitors for treatment of non-small cell lung cancer patients