Next Generation Sequencing (NGS) Tests Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Next Generation Sequencing (NGS) Tests Pipeline Market Overview

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 NGS technology has largely superseded Sanger sequencing in academic or genome research and is increasingly being applied in clinical practice.

Key Territories ·        The US

·        China

·        Global

·        Europe

·        South Korea

Key Regulatory Paths ·        510(k)

·        NMPA

·        PMA

·        CE-IVD

·        CLIA

Leading Companies ·        4bases SA

·        AccuraGen Inc

·        ACT Genomics Co LTD

·        Adaptive Biotechnologies Corp

·        Almac Diagnostic Services Ltd

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NGS Tests Pipeline Market Segmentation by Territories

A few of the key territories with the NGS tests pipeline market are the US, China, Global, Europe, and South Korea. As of May 2024, the US accounts for the highest number of NGS test pipeline products.

NGS Tests Pipeline Market Analysis by Territories, 2024 (%)

NGS Tests Pipeline Market Analysis by Territories, 2024 (%)

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NGS Tests Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the NGS test pipeline products market are 510(k), NMPA, PMA, CE-IVD, CLIA among others. As of May 2024, 510(k) is the most followed pathway for pipeline products in the NGS tests pipeline market.

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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NGS Tests Pipeline Market – Competitive Landscape

A few of the key companies associated with the NGS tests pipeline market are 4bases SA, AccuraGen Inc, ACT Genomics Co LTD, Adaptive Biotechnologies Corp, and Almac Diagnostic Services Ltd among others.

AccuraGen Inc: It is a company that develops blood tests that sequence cell-free DNA (cfDNA) to provide sensitive and accurate cancer diagnostics that facilitate more personalized cancer treatment. It provides molecular and bioinformatics technologies. The Company offers cell-free DNA-based liquid biopsy technology for personalized cancer treatment. Its Firefly is a robust technology that suppresses DNA sequencing errors.

ACT Genomics Co LTD: It is a subsidiary of Prenetics Global Ltd that develops solutions that provide treatment instructions for solid tumors, drug resistance, cancer monitoring, risk assessment, and immunotherapy evaluation. The company offers ACTOnco+, a genomic profiling service to support and overcome the challenges faced during the management of solid tumorsACTDrug+ solution for targeted genome profilingACTFusion to test fusion genesACTHRD and ACTBRCA solutions for DNA (deoxyribonucleic acid) repair gene testing.

NGS Tests Pipeline Market Analysis by Companies, 2024

NGS Tests Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

NGS Tests Pipeline Market Territories Outlook (2024)

  • The US
  • China
  • Global
  • Europe
  • South Korea

NGS Tests Pipeline Market Regulatory Paths Outlook (2024)

  • 510(k)
  • NMPA
  • PMA
  • CE-IVD
  • CLIA

Scope

This report provides:

  • Extensive coverage of the Aortic and Vascular Graft Devices under development.
  • An exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of Aortic and Vascular Graft Devices and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Aortic and Vascular Graft Devices under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

4bases SA
AccuraGen Inc
ACT Genomics Co LTD
Adaptive Biotechnologies Corp
Almac Diagnostic Services Ltd
Amoy Diagnostics Co Ltd
AnchorDx Medical Co Ltd
ArcherDx Inc
Berry Oncology Corp
BGI Genomics Co Ltd
Biocartis Group NV
Biodesix Inc
BioLink
bioTheranostics Inc
Boston University
Buhlmann Laboratories AG
Burning Rock Biotech Ltd
Cardiff Oncology Inc
CCM Biosciences Inc
Cerba HealthCare SAS
Cyclomics BV
DCGen Co Ltd
Eiken Chemical Co Ltd
Epic Sciences Inc
Epigenomics AG
FBB Biomed Inc
Feng Biosciences Inc
First Genetics JCS
Flomics Biotech
Foundation Medicine Inc
Gencurix Inc
GeneCast Biotechnology Co Ltd
Geneseeq Technology Inc
Genetron Health (Beijing) Co Ltd
Genomic Health Inc
GigaGen Inc
HaploX Biotechnology Co Ltd
Haystack Oncology Inc
HTG Molecular Diagnostics Inc
Illumina Inc
Immunovia AB
Inivata Ltd
Insight Genetics Inc
Invivoscribe Inc
IvyGene Diagnostics
Laboratory Corp of America Holdings
Leto Laboratories Co Ltd
Lucence Diagnostics Pte Ltd
MedySapiens Inc
Mega Genomics Ltd
Micronoma
MolecularMD Corp
NGeneBio Co Ltd
Novigenix SA
Novomics Co Ltd
NuGEN Technologies Inc
NuProbe Inc
Oncodiag
OncoDNA SA
OncoSpire Genomics
OrigiMed Inc
Otsuka Medical Devices Co Ltd
Pasteur Institute
Personal Genome Diagnostics Inc
Pillar Biosciences Inc
Predicine Inc
Predictive Biosciences Inc (Inactive)
PT PathGen Diagnostik Teknologi
Qiagen NV
Quantgene Inc
Queen's University
RealSeq Biosciences Inc
Rhodx Inc
Roche Diagnostics International Ltd
SeqOne SAS
Silicon Biosystems S.p.A.
Sophia Genetics SA
Sostos LLC
Spectrum Solutions LLC
Sysmex Corp
Sysmex Inostics GmbH
Tempus Health Inc
Tempus Labs Inc
Thermo Fisher Scientific Inc
Trivitron Healthcare Pvt Ltd
TwinStrand Biosciences Inc
University of Chicago
University of Michigan Rogel Cancer Center
University of Texas Health Science Center at Houston
Veracyte Inc
Vyant Bio Inc (Inactive)

Table of Contents

1 Table of Contents 3

1.1 List of Tables 10

1.2 List of Figures 20

2 Introduction 21

2.1 Next Generation Sequencing (NGS) Tests Overview 21

3 Products under Development 22

3.1 Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 22

3.2 Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 23

3.3 Next Generation Sequencing (NGS) Tests – Pipeline Products by Regulatory Path 24

3.4 Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 25

3.5 Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 26

4 Next Generation Sequencing (NGS) Tests – Pipeline Products under Development by Companies 27

4.1 Next Generation Sequencing (NGS) Tests Companies – Pipeline Products by Stage of Development 27

4.2 Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 31

5 Next Generation Sequencing (NGS) Tests Companies and Product Overview 36

5.1 4bases SA Company Overview 36

5.1.1 4bases SA Pipeline Products & Ongoing Clinical Trials Overview 36

5.2 AccuraGen Inc Company Overview 38

5.2.1 AccuraGen Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.3 ACT Genomics Co LTD Company Overview 39

5.3.1 ACT Genomics Co LTD Pipeline Products & Ongoing Clinical Trials Overview 39

5.4 Adaptive Biotechnologies Corp Company Overview 40

5.4.1 Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 40

5.5 Almac Diagnostic Services Ltd Company Overview 42

5.5.1 Almac Diagnostic Services Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.6 Amoy Diagnostics Co Ltd Company Overview 44

5.6.1 Amoy Diagnostics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 AnchorDx Medical Co Ltd Company Overview 45

5.7.1 AnchorDx Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

5.8 ArcherDx Inc Company Overview 48

5.8.1 ArcherDx Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.9 Berry Oncology Corp Company Overview 52

5.9.1 Berry Oncology Corp Pipeline Products & Ongoing Clinical Trials Overview 52

5.10 BGI Genomics Co Ltd Company Overview 53

5.10.1 BGI Genomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.11 Biocartis Group NV Company Overview 54

5.11.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 54

5.12 Biodesix Inc Company Overview 56

5.12.1 Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.13 BioLink Company Overview 58

5.13.1 BioLink Pipeline Products & Ongoing Clinical Trials Overview 58

5.14 bioTheranostics Inc Company Overview 59

5.14.1 bioTheranostics Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.15 Boston University Company Overview 60

5.15.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 60

5.16 Buhlmann Laboratories AG Company Overview 61

5.16.1 Buhlmann Laboratories AG Pipeline Products & Ongoing Clinical Trials Overview 61

5.17 Burning Rock Biotech Ltd Company Overview 63

5.17.1 Burning Rock Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.18 Cardiff Oncology Inc Company Overview 70

5.18.1 Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 70

5.19 CCM Biosciences Inc Company Overview 71

5.19.1 CCM Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.20 Cerba HealthCare SAS Company Overview 73

5.20.1 Cerba HealthCare SAS Pipeline Products & Ongoing Clinical Trials Overview 73

5.21 Cyclomics BV Company Overview 74

5.21.1 Cyclomics BV Pipeline Products & Ongoing Clinical Trials Overview 74

5.22 DCGen Co Ltd Company Overview 75

5.22.1 DCGen Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

5.23 Eiken Chemical Co Ltd Company Overview 77

5.23.1 Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

5.24 Epic Sciences Inc Company Overview 78

5.24.1 Epic Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.25 Epigenomics AG Company Overview 79

5.25.1 Epigenomics AG Pipeline Products & Ongoing Clinical Trials Overview 79

5.26 FBB Biomed Inc Company Overview 84

5.26.1 FBB Biomed Inc Pipeline Products & Ongoing Clinical Trials Overview 84

5.27 Feng Biosciences Inc Company Overview 85

5.27.1 Feng Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.28 First Genetics JCS Company Overview 86

5.28.1 First Genetics JCS Pipeline Products & Ongoing Clinical Trials Overview 86

5.29 Flomics Biotech Company Overview 87

5.29.1 Flomics Biotech Pipeline Products & Ongoing Clinical Trials Overview 87

5.30 Foundation Medicine Inc Company Overview 89

5.30.1 Foundation Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.31 Gencurix Inc Company Overview 93

5.31.1 Gencurix Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.32 GeneCast Biotechnology Co Ltd Company Overview 94

5.32.1 GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

5.33 Geneseeq Technology Inc Company Overview 101

5.33.1 Geneseeq Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 101

5.34 Genetron Health (Beijing) Co Ltd Company Overview 105

5.34.1 Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 105

5.35 Genomic Health Inc Company Overview 106

5.35.1 Genomic Health Inc Pipeline Products & Ongoing Clinical Trials Overview 106

5.36 GigaGen Inc Company Overview 108

5.36.1 GigaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.37 HaploX Biotechnology Co Ltd Company Overview 109

5.37.1 HaploX Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

5.38 Haystack Oncology Inc Company Overview 115

5.38.1 Haystack Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 115

5.39 HTG Molecular Diagnostics Inc Company Overview 118

5.39.1 HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.40 Illumina Inc Company Overview 120

5.40.1 Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 120

5.41 Immunovia AB Company Overview 126

5.41.1 Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 126

5.42 Inivata Ltd Company Overview 127

5.42.1 Inivata Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

5.43 Insight Genetics Inc Company Overview 134

5.43.1 Insight Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 134

5.44 Invivoscribe Inc Company Overview 135

5.44.1 Invivoscribe Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.45 IvyGene Diagnostics Company Overview 139

5.45.1 IvyGene Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 139

5.46 Laboratory Corp of America Holdings Company Overview 144

5.46.1 Laboratory Corp of America Holdings Pipeline Products & Ongoing Clinical Trials Overview 144

5.47 Leto Laboratories Co Ltd Company Overview 146

5.47.1 Leto Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

5.48 Lucence Diagnostics Pte Ltd Company Overview 148

5.48.1 Lucence Diagnostics Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

5.49 MedySapiens Inc Company Overview 149

5.49.1 MedySapiens Inc Pipeline Products & Ongoing Clinical Trials Overview 149

5.50 Mega Genomics Ltd Company Overview 150

5.50.1 Mega Genomics Ltd Pipeline Products & Ongoing Clinical Trials Overview 150

5.51 Micronoma Company Overview 154

5.51.1 Micronoma Pipeline Products & Ongoing Clinical Trials Overview 154

5.52 MolecularMD Corp Company Overview 160

5.52.1 MolecularMD Corp Pipeline Products & Ongoing Clinical Trials Overview 160

5.53 NGeneBio Co Ltd Company Overview 162

5.53.1 NGeneBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 162

5.54 Novigenix SA Company Overview 168

5.54.1 Novigenix SA Pipeline Products & Ongoing Clinical Trials Overview 168

5.55 Novomics Co Ltd Company Overview 171

5.55.1 Novomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 171

5.56 NuGEN Technologies Inc Company Overview 172

5.56.1 NuGEN Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 172

5.57 NuProbe Inc Company Overview 173

5.57.1 NuProbe Inc Pipeline Products & Ongoing Clinical Trials Overview 173

5.58 Oncodiag Company Overview 174

5.58.1 Oncodiag Pipeline Products & Ongoing Clinical Trials Overview 174

5.59 OncoDNA SA Company Overview 175

5.59.1 OncoDNA SA Pipeline Products & Ongoing Clinical Trials Overview 175

5.60 OncoSpire Genomics Company Overview 176

5.60.1 OncoSpire Genomics Pipeline Products & Ongoing Clinical Trials Overview 176

5.61 OrigiMed Inc Company Overview 177

5.61.1 OrigiMed Inc Pipeline Products & Ongoing Clinical Trials Overview 177

5.62 Otsuka Medical Devices Co Ltd Company Overview 180

5.62.1 Otsuka Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 180

5.63 Pasteur Institute Company Overview 182

5.63.1 Pasteur Institute Pipeline Products & Ongoing Clinical Trials Overview 182

5.64 Personal Genome Diagnostics Inc Company Overview 183

5.64.1 Personal Genome Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 183

5.65 Pillar Biosciences Inc Company Overview 185

5.65.1 Pillar Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.66 Predicine Inc Company Overview 188

5.66.1 Predicine Inc Pipeline Products & Ongoing Clinical Trials Overview 188

5.67 Predictive Biosciences Inc (Inactive) Company Overview 189

5.67.1 Predictive Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 189

5.68 PT PathGen Diagnostik Teknologi Company Overview 190

5.68.1 PT PathGen Diagnostik Teknologi Pipeline Products & Ongoing Clinical Trials Overview 190

5.69 Qiagen NV Company Overview 193

5.69.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 193

5.70 Quantgene Inc Company Overview 199

5.70.1 Quantgene Inc Pipeline Products & Ongoing Clinical Trials Overview 199

5.71 Queen’s University Company Overview 203

5.71.1 Queen’s University Pipeline Products & Ongoing Clinical Trials Overview 203

5.72 RealSeq Biosciences Inc Company Overview 204

5.72.1 RealSeq Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 204

5.73 Rhodx Inc Company Overview 205

5.73.1 Rhodx Inc Pipeline Products & Ongoing Clinical Trials Overview 205

5.74 Roche Diagnostics International Ltd Company Overview 206

5.74.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

5.75 SeqOne SAS Company Overview 208

5.75.1 SeqOne SAS Pipeline Products & Ongoing Clinical Trials Overview 208

5.76 Silicon Biosystems S.p.A. Company Overview 209

5.76.1 Silicon Biosystems S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 209

5.77 Sophia Genetics SA Company Overview 210

5.77.1 Sophia Genetics SA Pipeline Products & Ongoing Clinical Trials Overview 210

5.78 Sostos LLC Company Overview 212

5.78.1 Sostos LLC Pipeline Products & Ongoing Clinical Trials Overview 212

5.79 Spectrum Solutions LLC Company Overview 213

5.79.1 Spectrum Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 213

5.80 Sysmex Corp Company Overview 214

5.80.1 Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 214

5.81 Sysmex Inostics GmbH Company Overview 215

5.81.1 Sysmex Inostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 215

5.82 Tempus Health Inc Company Overview 216

5.82.1 Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview 216

5.83 Tempus Labs Inc Company Overview 219

5.83.1 Tempus Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 219

5.84 Thermo Fisher Scientific Inc Company Overview 221

5.84.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 221

5.85 Trivitron Healthcare Pvt Ltd Company Overview 229

5.85.1 Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 229

5.86 TwinStrand Biosciences Inc Company Overview 230

5.86.1 TwinStrand Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 230

5.87 University of Chicago Company Overview 231

5.87.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 231

5.88 University of Michigan Rogel Cancer Center Company Overview 232

5.88.1 University of Michigan Rogel Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 232

5.89 University of Texas Health Science Center at Houston Company Overview 233

5.89.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 233

5.90 Veracyte Inc Company Overview 234

5.90.1 Veracyte Inc Pipeline Products & Ongoing Clinical Trials Overview 234

5.91 Vyant Bio Inc (Inactive) Company Overview 235

5.91.1 Vyant Bio Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 235

6 Next Generation Sequencing (NGS) Tests- Recent Developments 236

6.1 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 236

6.2 Apr 29, 2024: GenomOncology Introduces Expanded Support for Germline Testing in GO Pathology Workbench 236

6.3 Apr 24, 2024: TwinStrand Biosciences Initiates Regulatory Approval Process for Duplex Sequencing Mutagenesis Assays with OECD 237

6.4 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 237

6.5 Apr 11, 2024: German Gynecological Oncology Group (AGO) Recognizes BluePrint in Breast Cancer Guidelines 238

6.6 Apr 11, 2024: Predicine Introduces Predicinecare NGS Kit for Tumor Profiling 239

6.7 Apr 05, 2024: Predicine Introduces PredicineCARE NGS Kit for Global Clinical Trials, CDx Development and Patient Testing 239

6.8 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 239

6.9 Mar 26, 2024: 10x Genomics Commercially Launches Visium HD Spatial Gene Expression Assay 241

6.10 Mar 21, 2024: Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date 241

6.11 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 242

6.12 Mar 19, 2024: Singular Genomics Systems Reports Results for the Quarter Ended in December – Earnings 244

6.13 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 244

6.14 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 246

6.15 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 247

6.16 Feb 27, 2024: Natera Announces Next Phase of CareDx Patent Infringement Litigation Seeking Royalty For All Ongoing And Future AlloSure Tests 248

6.17 Feb 21, 2024: Tempus Expanding Access to its Next-Generation Sequencing Tests as an In-Network Provider for Cigna 248

6.18 Feb 06, 2024: Volta Labs and Integrated DNA Technologies Partner to Advance Target Enrichment Workflows 248

6.19 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 249

6.20 Jan 18, 2024: Tempus launches MRD assay for colorectal cancer research 250

6.21 Jan 18, 2024: Quantum-Si Introduces World’s First Next-Generation Protein Sequencer in Japan with Addition of New Distributor 251

6.22 Jan 17, 2024: Revolutionizing Drug Development: Novigenix Unveils AI-Powered RNA Analysis for Immune Response Profiling 251

6.23 Jan 16, 2024: Personalis Announces Medicare Coverage for NeXT Dx(R) Comprehensive Genomic Tumor Profiling Assay 252

6.24 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 252

6.25 Jan 09, 2024: Myriad Genetics Applauds New Germline Testing Guideline for Patients with Breast Cancer from ASCO-SSO 254

6.26 Jan 09, 2024: Quest Diagnostics and Ultima Collaborate to Scale Ultima’s Technology in Fast-Growing Minimal Residual Disease and Whole Genome Sequencing 255

6.27 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 256

6.28 Jan 04, 2024: Geneseeq scores FDA breakthrough designation for cancer detection device 256

6.29 Dec 27, 2023: Natera Wins Preliminary Injunction in Patent Infringement Lawsuit Against NeoGenomics’ RaDaR Test 257

6.30 Dec 14, 2023: Haystack Oncology and Rutgers Cancer Institute Collaborate to use Haystack MRD in Clinical Study of Early-Stage Triple-Negative Breast Cancer 257

6.31 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 258

6.32 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 259

6.33 Dec 05, 2023: NeoGenomics to Present New Data at San Antonio Breast Cancer Symposium Highlighting Utility of RaDaR for Therapy Response 260

6.34 Dec 01, 2023: Strata Oncology Announces Presentations on Proprietary Multivariate Biomarkers at North America Conference on Lung Cancer and San Antonio Breast Cancer Symposium 261

6.35 Nov 28, 2023: NGeneBio’s Blood Cancer Diagnostic Panel Gets Permit in Thailand 262

6.36 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 HR-Positive, HER2-Negative Advanced Breast Cancer 263

6.37 Nov 20, 2023: Roswell Park Launches Advanced, High-Speed Blood Cancer Test 264

6.38 Nov 15, 2023: Tempus Announces Medicare Coverage for Tempus|xT Across Solid Tumor and Hematologic Malignancies 264

6.39 Nov 14, 2023: Castle Biosciences Announces Multiple Data Presentations at the 2023 American Society for Dermatologic Surgery Annual Meeting 265

6.40 Nov 06, 2023: Invitae Launches Enhanced Chemistry of MRD Test to Better Serve Biopharmaceutical Clinical and Research Partnerships 267

6.41 Nov 06, 2023: NGeneBio Releases Upgraded NGS-Based Companion Diagnostics for Cancer 268

6.42 Oct 26, 2023: Foundation Medicine Announces Participation in National Cancer Institute’s ComboMATCH Initiative to Connect Patients with New Anti-Cancer Drug Combinations 268

6.43 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 269

6.44 Oct 19, 2023: Foundation Medicine Announces Acceptance of 11 Abstracts at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting 270

6.45 Oct 18, 2023: New Data Highlights Clinical Utility and Performance of Castle Biosciences’ Dermatologic Test Portfolio at the 2023 Fall Clinical Dermatology Conference 272

6.46 Oct 17, 2023: Predicine Announces Six Studies Showcasing Mrd and Liquid Biopsy Innovations at ESMO 2023 273

6.47 Oct 15, 2023: Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test 274

6.48 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 274

6.49 Oct 10, 2023: Karius Test Improves the Diagnosis and Management of Pneumonia in Patients Undergoing Treatment for Blood Cancer 275

6.50 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 276

6.51 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 277

6.52 Sep 28, 2023: New Neoadjuvant Trial Confirms the Predictive Utility of Mammaprint + Blueprint 278

6.53 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 279

6.54 Sep 19, 2023: Pillar Biosciences Launches oncoReveal Core LBx, an NGS Kit to Enable Localized Liquid Biopsy Testing 279

6.55 Sep 19, 2023: Myriad Genetics and Illumina Achieve Milestones in Strategic Partnership to Support Biopharma Clinical Trials 280

6.56 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 280

6.57 Aug 22, 2023: New Study Shows UroAmp Can Detect Bladder Cancer Not Found by Cystoscopy or Urine Cytology 281

6.58 Aug 22, 2023: Myriad Genetics And Onsite Women’s Health Partner To Help More Women Understand Breast Cancer Risk 282

6.59 Aug 22, 2023: Geneseeq Gains CE Marks For NGS-based Test Kits For Solid Tumors And Hematological Cancer 283

6.60 Aug 21, 2023: Scale Biosciences And Basepair To Democratize Single Cell Sequencing Data Analysis 283

6.61 Aug 16, 2023: 4BASES Announces the Readiness of a CFTR Mutations Detection Solution 284

6.62 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 284

6.63 Aug 02, 2023: Karius Test, a Liquid Biopsy for Infectious Diseases, Incorporated into Diagnostics Recommendation in the 2023 Duke-ISCVID Criteria for Infective Endocarditis 285

6.64 Jul 27, 2023: NeoGenomics Announces Medicare Coverage for RaDaR Assay for Minimal Residual Disease and Recurrence in Breast Cancer 286

6.65 Jul 24, 2023: Myriad Genetics Announces Inclusion of Breast Density to MyRisk with RiskScore Breast Cancer Risk Assessment 286

6.66 Jul 12, 2023: Tempus Announces the GEMINI Non-Small Cell Lung Cancer Study 287

6.67 Jun 30, 2023: Novigenix Reports Interim European Validation Data on Its New NGS-Based Whole Blood RNA Signature for Detection of Advanced Colorectal Adenomas 288

6.68 Jun 15, 2023: Neogenomics’ RaDaR Assay for Minimal Residual Disease Receives First Commercial Coverage 288

6.69 Jun 12, 2023: FDA approves FoundationOne Liquid CDx as companion diagnostic for Braftovi 289

6.70 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 290

6.71 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 290

6.72 Jun 08, 2023: Imbdx Expands Targeted Therapies Agreement Following Successful Evaluation of Blood-Based Genomic Profiling Assay in Prostate Cancer 291

6.73 Jun 08, 2023: Published in the New England Journal of Medicine 291

6.74 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 292

6.75 Jun 05, 2023: NeoGenomics and German Breast Group Announce New Data Demonstrating Clinical Potential of the RaDaR MRD Assay in HR+/HER2- Breast Cancer 292

6.76 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 294

6.77 Jun 01, 2023: Labcorp introduces new liquid biopsy test 295

6.78 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 295

6.79 May 30, 2023: NeoGenomics to showcase the transformational impact of RaDaR assay for molecular residual disease and recurrence monitoring at ASCO 296

6.80 May 25, 2023: Digi7 launches Geneyx AI-based solution to analyse next-generation sequencing data at Mediclinic 298

6.81 May 23, 2023: Tempus Labs receives CLIA approval for xT CDx Test 298

7 Appendix 299

7.1 Methodology 299

7.2 About GlobalData 302

7.3 Contact Us 302

7.4 Disclaimer 302

Table

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 21

Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 22

Next Generation Sequencing (NGS) Tests – Pipeline Products by Regulatory Path 24

Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 25

Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 26

Next Generation Sequencing (NGS) Tests Companies – Pipeline Products by Stage of Development 27

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 31

4bases SA Pipeline Products & Ongoing Clinical Trials Overview 36

BRaVO Screen – Product Status 36

BRaVO Screen – Product Description 36

AccuraGen Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Firefly – Product Status 38

Firefly – Product Description 38

ACT Genomics Co LTD Pipeline Products & Ongoing Clinical Trials Overview 39

ACTSpot NTRK Test – Product Status 39

ACTSpot NTRK Test – Product Description 39

Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 40

ClonoSEQ Assay – Non-Hodgkin’s Lymphoma – Product Status 40

ClonoSEQ Assay – Non-Hodgkin’s Lymphoma – Product Description 40

Almac Diagnostic Services Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

Next-Generation Sequencing Based Companion Diagnostic Assay – Product Status 42

Next-Generation Sequencing Based Companion Diagnostic Assay – Product Description 42

Pan-Cancer Companion Diagnostic Assay – Product Status 42

Pan-Cancer Companion Diagnostic Assay – Product Description 43

Amoy Diagnostics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

AmoyDx LC10-Essential NGS Panel – Product Status 44

AmoyDx LC10-Essential NGS Panel – Product Description 44

AnchorDx Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

NGS-Based Multi-Cancer Screening Test – Product Status 45

NGS-Based Multi-Cancer Screening Test – Product Description 45

NGS-Based Pan-Cancer Panel – Product Status 46

NGS-Based Pan-Cancer Panel – Product Description 46

NGS-Based Single-Cancer Screening Test – Product Status 46

NGS-Based Single-Cancer Screening Test – Product Description 46

PulmoSeek Plus – Product Status 47

PulmoSeek Plus – Product Description 47

ArcherDx Inc Pipeline Products & Ongoing Clinical Trials Overview 48

AMP-Based Assay – Cancer – Product Status 48

AMP-Based Assay – Cancer – Product Description 48

NextSeq 550Dx System – Blood Cancer CDx Assay – Product Status 49

NextSeq 550Dx System – Blood Cancer CDx Assay – Product Description 49

NextSeq 550Dx System – Minimal Residual Disease Assay – Product Status 49

NextSeq 550Dx System – Minimal Residual Disease Assay – Product Description 49

NextSeq 550Dx System – Solid Tumor CDx Assay – Product Status 50

NextSeq 550Dx System – Solid Tumor CDx Assay – Product Description 50

NGS-Based Companion Diagnostic Assay – Cancer – Product Status 50

NGS-Based Companion Diagnostic Assay – Cancer – Product Description 51

Berry Oncology Corp Pipeline Products & Ongoing Clinical Trials Overview 52

Lai Si Ning – Product Status 52

Lai Si Ning – Product Description 52

BGI Genomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

SENTIS Colorectal Cancer Panel – Liquid Biopsy Version – Product Status 53

SENTIS Colorectal Cancer Panel – Liquid Biopsy Version – Product Description 53

Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 54

Idylla NGS Prep Panel – Lung – Product Status 54

Idylla NGS Prep Panel – Lung – Product Description 54

Idylla Retrieve – NGS Hotspot Panel Assay – Product Status 55

Idylla Retrieve – NGS Hotspot Panel Assay – Product Description 55

Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 56

52-Gene Panel Based Companion Diagnostic – Product Status 56

52-Gene Panel Based Companion Diagnostic – Product Description 56

TAm-Seq NGS Lung Cancer Test – Product Status 57

TAm-Seq NGS Lung Cancer Test – Product Description 57

BioLink Pipeline Products & Ongoing Clinical Trials Overview 58

Diagnostic Test – Breast Cancer – Product Status 58

Diagnostic Test – Breast Cancer – Product Description 58

bioTheranostics Inc Pipeline Products & Ongoing Clinical Trials Overview 59

CancerTREATMENT ID – Product Status 59

CancerTREATMENT ID – Product Description 59

Boston University Pipeline Products & Ongoing Clinical Trials Overview 60

Diagnostic Test – Esophageal Adenocarcinoma – Product Status 60

Diagnostic Test – Esophageal Adenocarcinoma – Product Description 60

Buhlmann Laboratories AG Pipeline Products & Ongoing Clinical Trials Overview 61

NGS Targeted Hotspot Panel 16 Kit – Product Status 61

NGS Targeted Hotspot Panel 16 Kit – Product Description 61

Burning Rock Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

22-Cancer Test – Product Status 63

22-Cancer Test – Product Description 63

OncoCompass Target CDx Test – Tepotinib – Product Status 64

OncoCompass Target CDx Test – Tepotinib – Product Description 64

OverC Multi-Cancer Detection Blood Test Kit – Product Status 64

OverC Multi-Cancer Detection Blood Test Kit – Product Description 65

Burning Rock Biotech Ltd – Ongoing Clinical Trials Overview 66

OverC Multi-Cancer Detection Blood Test Kit – A Prospective Multi-cancer Early-detection and Interventional Study in Asymptomatic Individuals: PREVENT 67

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) 67

OverC Multi-Cancer Detection Blood Test Kit – Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study 67

OverC Multi-Cancer Detection Blood Test Kit – Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study 67

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 68

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) 68

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 68

OverC Multi-Cancer Detection Blood Test Kit – Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: A Multi-center, Prospective Observational Study 69

Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 70

Mutation Enrichment Kit – Product Status 70

Mutation Enrichment Kit – Product Description 70

CCM Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 71

FLT3 Fusion Bias-free NGS based Companion Diagnostic Assay – Product Status 71

FLT3 Fusion Bias-free NGS based Companion Diagnostic Assay – Product Description 71

ROS1/Trk Fusion Bias-free NGS based Companion Diagnostic Assay – Product Status 71

ROS1/Trk Fusion Bias-free NGS based Companion Diagnostic Assay – Product Description 72

Cerba HealthCare SAS Pipeline Products & Ongoing Clinical Trials Overview 73

Diagnostic Test – Cancer – Product Status 73

Diagnostic Test – Cancer – Product Description 73

Cyclomics BV Pipeline Products & Ongoing Clinical Trials Overview 74

CyclomicsSeq TP53 Diagnostic Kit – Product Status 74

CyclomicsSeq TP53 Diagnostic Kit – Product Description 74

DCGen Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 75

HOPE – Product Status 75

HOPE – Product Description 75

OncoFREE – Product Status 75

OncoFREE – Product Description 76

Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

Companion Diagnostic Kit – Non-Small Cell Lung Cancer – Product Status 77

Companion Diagnostic Kit – Non-Small Cell Lung Cancer – Product Description 77

Epic Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 79

DefineMBC – Product Status 79

DefineMBC – Product Description 79

Epigenomics AG Pipeline Products & Ongoing Clinical Trials Overview 80

NGS Panel – Bladder Cancer – Product Status 80

NGS Panel – Bladder Cancer – Product Description 80

NGS Panel – Breast Cancer – Product Status 81

NGS Panel – Breast Cancer – Product Description 81

NGS Panel – Colon Cancer – Product Status 81

NGS Panel – Colon Cancer – Product Description 81

NGS Panel – Lung Cancer – Product Status 82

NGS Panel – Lung Cancer – Product Description 82

NGS Panel – Ovarian Cancer – Product Status 82

NGS Panel – Ovarian Cancer – Product Description 83

NGS Panel – Prostate Cancer – Product Status 83

NGS Panel – Prostate Cancer – Product Description 83

FBB Biomed Inc Pipeline Products & Ongoing Clinical Trials Overview 84

Liquid Biopsy Test – Brain Cancer – Product Status 84

Liquid Biopsy Test – Brain Cancer – Product Description 84

Feng Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 85

Xerna TME Companion Diagnostic Assay – Ovarian Cancer – Product Status 85

Xerna TME Companion Diagnostic Assay – Ovarian Cancer – Product Description 85

First Genetics JCS Pipeline Products & Ongoing Clinical Trials Overview 86

F-Genetics NGS System – Oncology – Product Status 86

F-Genetics NGS System – Oncology – Product Description 86

Flomics Biotech Pipeline Products & Ongoing Clinical Trials Overview 87

Colon Cancer Diagnostic Test – Product Status 87

Colon Cancer Diagnostic Test – Product Description 87

Lung Cancer Diagnostic Test – Product Status 88

Lung Cancer Diagnostic Test – Product Description 88

Foundation Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 89

FoundationOne CDx – BI 907828 – Product Status 89

FoundationOne CDx – BI 907828 – Product Description 89

FoundationOne CDx – Taletrectinib – Product Status 90

FoundationOne CDx – Taletrectinib – Product Description 90

FoundationOne CDx – Vitrakvi – Product Status 90

FoundationOne CDx – Vitrakvi – Product Description 91

FoundationOne Liquid CDx – Taletrectinib – Product Status 91

FoundationOne Liquid CDx – Taletrectinib – Product Description 91

Gencurix Inc Pipeline Products & Ongoing Clinical Trials Overview 92

NGS (Next Generation Sequencing) Cancer Test – Product Status 92

NGS (Next Generation Sequencing) Cancer Test – Product Description 92

GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 93

Genecast IVD – Comprehensive – Product Status 93

Genecast IVD – Comprehensive – Product Description 93

Genecast IVD – ctDNA Focus – Product Status 94

Genecast IVD – ctDNA Focus – Product Description 94

Genecast IVD – Early Detection Multi-Cancer – Product Status 94

Genecast IVD – Early Detection Multi-Cancer – Product Description 95

Genecast IVD – KNBP – Melanoma – Product Status 95

Genecast IVD – KNBP – Melanoma – Product Description 95

Genecast IVD – MammaPrint – Product Status 96

Genecast IVD – MammaPrint – Product Description 96

Genecast IVD – MRD Solid Tumors – Product Status 96

Genecast IVD – MRD Solid Tumors – Product Description 97

Genecast IVD – RNA Fusion Focus – Product Status 97

Genecast IVD – RNA Fusion Focus – Product Description 97

Geneseeq Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 99

CanScan MCED Kit – Product Status 99

CanScan MCED Kit – Product Description 99

Comprehensive Cancer NGS Diagnostic Kit – Product Status 99

Comprehensive Cancer NGS Diagnostic Kit – Product Description 100

Geneseeq Technology Inc – Ongoing Clinical Trials Overview 101

CanScan MCED Kit – A Prospective, Multicenter Cohort Study of the Multi-omics Liquid Biopsy MCED Test MERCURY in an Average Risk Chinese Population 102

Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 103

Blood-Based Lung EGFR NGS IVD Assay – Product Status 103

Blood-Based Lung EGFR NGS IVD Assay – Product Description 103

Genomic Health Inc Pipeline Products & Ongoing Clinical Trials Overview 104

Liquid Biopsy-Based Bladder Cancer Test – Product Status 104

Liquid Biopsy-Based Bladder Cancer Test – Product Description 104

Next Generation Sequencing Oncotype DX – Prostate Cancer Assay – Product Status 104

Next Generation Sequencing Oncotype DX – Prostate Cancer Assay – Product Description 105

GigaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 106

GigaMune HemeOnc – Product Status 106

GigaMune HemeOnc – Product Description 106

HaploX Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 107

HaploX AiScreening Pan-cancer Early Screening Testing Kit – IVD – Product Status 107

HaploX AiScreening Pan-cancer Early Screening Testing Kit – IVD – Product Description 107

HaploX AiScreening Pan-cancer Early Screening Testing Kit – LDT – Product Status 108

HaploX AiScreening Pan-cancer Early Screening Testing Kit – LDT – Product Description 108

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – IVD – Product Status 108

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – IVD – Product Description 109

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – LDT – Product Status 109

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – LDT – Product Description 109

HaploX UrineScope Urological Tumor Screening Testing Kit – IVD – Product Status 110

HaploX UrineScope Urological Tumor Screening Testing Kit – IVD – Product Description 110

HaploX UrineScope Urological Tumor Screening Testing Kit – LDT – Product Status 110

HaploX UrineScope Urological Tumor Screening Testing Kit – LDT – Product Description 110

HapOnco PharmCDx NGS Testing Kit – Product Status 111

HapOnco PharmCDx NGS Testing Kit – Product Description 111

HapOnco WESPlus NGS Testing Kit – Pan Cancer – Product Status 111

HapOnco WESPlus NGS Testing Kit – Pan Cancer – Product Description 112

Haystack Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 113

MRD Test – Breast Cancer – Product Status 113

MRD Test – Breast Cancer – Product Description 113

MRD Test – Colorectal Cancer – Product Status 114

MRD Test – Colorectal Cancer – Product Description 114

MRD Test – Lung Cancer – Product Status 114

MRD Test – Lung Cancer – Product Description 114

HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 116

CNV Navigator – Product Status 116

CNV Navigator – Product Description 116

Ion PGM Dx System – Cancer Assay – Product Status 117

Ion PGM Dx System – Cancer Assay – Product Description 117

Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 118

Companion Diagnostic Test – Oncology – Product Status 118

Companion Diagnostic Test – Oncology – Product Description 118

TruSight Oncology 500 – TP53 CDx Assay – Product Status 119

TruSight Oncology 500 – TP53 CDx Assay – Product Description 119

TruSight Oncology 500 HRD – Product Status 119

TruSight Oncology 500 HRD – Product Description 119

TruSight Tumor 170 CDx – LOXO-101 – Product Status 120

TruSight Tumor 170 CDx – LOXO-101 – Product Description 120

TruSight Tumor 170 CDx – LOXO-292 – Product Status 120

TruSight Tumor 170 CDx – LOXO-292 – Product Description 121

Illumina Inc – Ongoing Clinical Trials Overview 122

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 123

Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 124

ProMIS Assay – Product Status 124

ProMIS Assay – Product Description 124

Inivata Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

InVision ctDNA Assay – EGFR-Mutant NSCLC – Product Status 125

InVision ctDNA Assay – EGFR-Mutant NSCLC – Product Description 125

InVision ctDNA Assay – Metastatic Breast Cancer – Product Status 126

InVision ctDNA Assay – Metastatic Breast Cancer – Product Description 126

InVision ctDNA Assay – NSCLC – Product Status 126

InVision ctDNA Assay – NSCLC – Product Description 127

InVision ctDNA Assay – Pancreatic Cancer – Product Status 127

InVision ctDNA Assay – Pancreatic Cancer – Product Description 127

InVision ctDNA Assay – Stage III/IV NSCLC – Product Status 128

InVision ctDNA Assay – Stage III/IV NSCLC – Product Description 128

RaDaR Assay – Product Status 128

RaDaR Assay – Product Description 128

Inivata Ltd – Ongoing Clinical Trials Overview 130

RaDaR Assay – Liquid Biopsy for Minimal Residual Disease Detection in Head and Necksquamous Cell Carcinoma (LIONESS) Study 131

RaDaR Assay – SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) – a Partially Double-blinded, Multi-center, Randomized, Controlled Superiority Study 131

Insight Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 132

NGS Lung Panel Test – Product Status 132

NGS Lung Panel Test – Product Description 132

Invivoscribe Inc Pipeline Products & Ongoing Clinical Trials Overview 133

B-cell Immuno-Oncology Assay Kit – Product Status 133

B-cell Immuno-Oncology Assay Kit – Product Description 133

LymphoTrack Dx TRB Assay – PGM – Product Status 134

LymphoTrack Dx TRB Assay – PGM – Product Description 134

MiSeqDx – Cancer Diagnostic Test – Product Status 134

MiSeqDx – Cancer Diagnostic Test – Product Description 134

NGS Based Hematologic Malignancy Test – Product Status 135

NGS Based Hematologic Malignancy Test – Product Description 135

T-cell Immuno-Oncology Assay Kit – Product Status 135

T-cell Immuno-Oncology Assay Kit – Product Description 136

IvyGene Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 137

IvyGene Test – Brain Cancer – Product Status 137

IvyGene Test – Brain Cancer – Product Description 137

IvyGene Test – Breast Cancer – Product Status 138

IvyGene Test – Breast Cancer – Product Description 138

IvyGene Test – Colorectal Cancer – Product Status 138

IvyGene Test – Colorectal Cancer – Product Description 139

IvyGene Test – Lung Cancer – Product Status 139

IvyGene Test – Lung Cancer – Product Description 139

IvyGene Test – Nasopharyngeal Carcinoma – Product Status 140

IvyGene Test – Nasopharyngeal Carcinoma – Product Description 140

IvyGene Test – Ovarian Cancer – Product Status 140

IvyGene Test – Ovarian Cancer – Product Description 140

IvyGene Test – Pancreatic Cancer – Product Status 141

IvyGene Test – Pancreatic Cancer – Product Description 141

Laboratory Corp of America Holdings Pipeline Products & Ongoing Clinical Trials Overview 142

IntelliGEN Myeloid Test – Product Status 142

IntelliGEN Myeloid Test – Product Description 142

Leto Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

Companion Diagnostic Test – Solid Tumors – Product Status 144

Companion Diagnostic Test – Solid Tumors – Product Description 144

Prognostic Test – Solid Tumor Immunotherapy – Product Status 145

Prognostic Test – Solid Tumor Immunotherapy – Product Description 145

Lucence Diagnostics Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

Lymphoma Subtype Test – Product Status 146

Lymphoma Subtype Test – Product Description 146

MedySapiens Inc Pipeline Products & Ongoing Clinical Trials Overview 147

NEOseq_Cancer – Product Status 147

NEOseq_Cancer – Product Description 147

Mega Genomics Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

BRCA1/BRCA2 Gene Mutation Diagnostic Kit – Product Status 148

BRCA1/BRCA2 Gene Mutation Diagnostic Kit – Product Description 148

Cervical Cancer Screening Kit – Product Status 149

Cervical Cancer Screening Kit – Product Description 149

Colorectal Cancer Screening Kit – Product Status 149

Colorectal Cancer Screening Kit – Product Description 149

Gastric Cancer Screening Kit – Product Status 150

Gastric Cancer Screening Kit – Product Description 150

Lung Nodule Auxiliary Diagnostic Kit – Product Status 150

Lung Nodule Auxiliary Diagnostic Kit – Product Description 151

Micronoma Pipeline Products & Ongoing Clinical Trials Overview 152

Oncobiota – Minimal Residual Disease (MRD) Assay – Product Status 152

Oncobiota – Minimal Residual Disease (MRD) Assay – Product Description 152

Oncobiota Companion Diagnostic Test – Product Status 153

Oncobiota Companion Diagnostic Test – Product Description 153

OncobiotaBREAST detect – Product Status 153

OncobiotaBREAST detect – Product Description 154

OncobiotaCOLORECTAL detect – Product Status 154

OncobiotaCOLORECTAL detect – Product Description 154

OncobiotaLIVER detect – Product Status 155

OncobiotaLIVER detect – Product Description 155

OncobiotaOVARIAN detect – Product Status 155

OncobiotaOVARIAN detect – Product Description 156

MolecularMD Corp Pipeline Products & Ongoing Clinical Trials Overview 157

NGS Assay – Lung Cancer – Product Status 157

NGS Assay – Lung Cancer – Product Description 157

Notch1 NGS Test – Chronic Lymphocytic Leukemia – Product Status 158

Notch1 NGS Test – Chronic Lymphocytic Leukemia – Product Description 158

NGeneBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 159

Analytical Performance Test – Solid Cancer – Product Status 159

Analytical Performance Test – Solid Cancer – Product Description 159

BRCA NGS Panel For PARP Inhibitor CDx Test – Product Status 160

BRCA NGS Panel For PARP Inhibitor CDx Test – Product Description 160

Clinical Performance Test – Solid Cancer – Product Status 160

Clinical Performance Test – Solid Cancer – Product Description 161

Laboratory-Developed Test – Hematologic Malignancy – Product Status 161

Laboratory-Developed Test – Hematologic Malignancy – Product Description 161

LUNGaccuTest – Product Status 162

LUNGaccuTest – Product Description 162

SOLIDaccuCDx SOMATIC – Product Status 162

SOLIDaccuCDx SOMATIC – Product Description 163

SOLIDaccuTest – Talazoparib – Product Status 163

SOLIDaccuTest – Talazoparib – Product Description 163

Novigenix SA Pipeline Products & Ongoing Clinical Trials Overview 164

LITOSeekColon – Product Status 164

LITOSeekColon – Product Description 164

LITOseekColonMon – Product Status 165

LITOseekColonMon – Product Description 165

LITOSeekProstate – Product Status 165

LITOSeekProstate – Product Description 165

Precision Diagnostic Test – Neuroendocrine Tumor – Product Status 166

Precision Diagnostic Test – Neuroendocrine Tumor – Product Description 166

Novomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 167

Companion Diagnostic Test – Lung Cancer – Product Status 167

Companion Diagnostic Test – Lung Cancer – Product Description 167

NuGEN Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 168

Epigenetic Test – Cancer – Product Status 168

Epigenetic Test – Cancer – Product Description 168

NuProbe Inc Pipeline Products & Ongoing Clinical Trials Overview 169

Liquid Biopsy NGS Panel – Non-Small Cell Lung Cancer – Product Status 169

Liquid Biopsy NGS Panel – Non-Small Cell Lung Cancer – Product Description 169

Oncodiag Pipeline Products & Ongoing Clinical Trials Overview 170

Prostadiag – Product Status 170

Prostadiag – Product Description 170

OncoDNA SA Pipeline Products & Ongoing Clinical Trials Overview 171

Companion Diagnostic Assay – Tipifarnib – Product Status 171

Companion Diagnostic Assay – Tipifarnib – Product Description 171

OncoSpire Genomics Pipeline Products & Ongoing Clinical Trials Overview 172

Next-Generation Sequencing Test – Lung Cancer – Product Status 172

Next-Generation Sequencing Test – Lung Cancer – Product Description 172

OrigiMed Inc Pipeline Products & Ongoing Clinical Trials Overview 173

NGS-Based CDx – Larotrectinib – Product Status 173

NGS-Based CDx – Larotrectinib – Product Description 173

OrigiMed Inc – Ongoing Clinical Trials Overview 174

NGS-Based CDx – Larotrectinib – A Prospective Study on NGS-based Comprehensive Genomic ctDNA Panel in NSCLC Treated with Immunotherapy 175

Otsuka Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

NextSeq 550Dx System – Acute Lymphoblastic Leukemia Assay – Product Status 176

NextSeq 550Dx System – Acute Lymphoblastic Leukemia Assay – Product Description 176

NextSeq 550Dx System – Acute Myeloid Leukemia Assay – Product Status 177

NextSeq 550Dx System – Acute Myeloid Leukemia Assay – Product Description 177

Pasteur Institute Pipeline Products & Ongoing Clinical Trials Overview 178

HPV RNA-Seq Test – Product Status 178

HPV RNA-Seq Test – Product Description 178

Personal Genome Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 179

PGDx elio Plasma Resolve – Product Status 179

PGDx elio Plasma Resolve – Product Description 179

Precision Diagnostics Tool – Product Status 180

Precision Diagnostics Tool – Product Description 180

Pillar Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 181

IVD Onco/Reveal Dx Assay – Blood Cancer – Product Status 181

IVD Onco/Reveal Dx Assay – Blood Cancer – Product Description 181

IVD Onco/Reveal Dx Assay – Liquid Biopsy – Product Status 182

IVD Onco/Reveal Dx Assay – Liquid Biopsy – Product Description 182

IVD Onco/Reveal Dx Assay – Tumor Tissue Testing – Product Status 182

IVD Onco/Reveal Dx Assay – Tumor Tissue Testing – Product Description 182

Predicine Inc Pipeline Products & Ongoing Clinical Trials Overview 184

PredicineCARE Companion Diagnostic Test – Product Status 184

PredicineCARE Companion Diagnostic Test – Product Description 184

Predictive Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 185

CertNDx Bladder Cancer Assay – TP53 – Product Status 185

CertNDx Bladder Cancer Assay – TP53 – Product Description 185

PT PathGen Diagnostik Teknologi Pipeline Products & Ongoing Clinical Trials Overview 186

Molecular Genetic Test Kit – Cervical Cancer – Product Status 186

Molecular Genetic Test Kit – Cervical Cancer – Product Description 186

Molecular Genetic Test Kit – Lung Cancer – Product Status 186

Molecular Genetic Test Kit – Lung Cancer – Product Description 187

Molecular Genetic Test Kit – Nasopharynx Cancer – Product Status 187

Molecular Genetic Test Kit – Nasopharynx Cancer – Product Description 187

Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 189

Companion Diagnostic Assay – Precancerous Cervical Lesions – Product Status 189

Companion Diagnostic Assay – Precancerous Cervical Lesions – Product Description 189

GeneRead QIAact Lung All-in-One Assay – Product Status 190

GeneRead QIAact Lung All-in-One Assay – Product Description 190

GeneReader NGS System – BRCA Liquid Biopsy Assay – Product Status 190

GeneReader NGS System – BRCA Liquid Biopsy Assay – Product Description 191

GeneReader NGS System – Leukemia – Product Status 191

GeneReader NGS System – Leukemia – Product Description 191

GeneReader NGS System – MPN – Product Status 191

GeneReader NGS System – MPN – Product Description 192

QIAact Breast Panel (Expanded) – Product Status 192

QIAact Breast Panel (Expanded) – Product Description 192

QIAact Lung Panel (CNV And Fusion) – Product Status 193

QIAact Lung Panel (CNV And Fusion) – Product Description 193

QIAact Onco-Heme Panel – Myeloid – Product Status 193

QIAact Onco-Heme Panel – Myeloid – Product Description 193

Quantgene Inc Pipeline Products & Ongoing Clinical Trials Overview 195

DEEPGEN Panel – Product Status 195

DEEPGEN Panel – Product Description 195

Liquid Biopsy Assay – Cancer Recurrence Monitoring – Product Status 196

Liquid Biopsy Assay – Cancer Recurrence Monitoring – Product Description 196

Liquid Biopsy Assay – Minimum Residual Disease – Product Status 197

Liquid Biopsy Assay – Minimum Residual Disease – Product Description 197

Liquid Biopsy Companion Diagnostic Assay – Product Status 198

Liquid Biopsy Companion Diagnostic Assay – Product Description 198

Queen’s University Pipeline Products & Ongoing Clinical Trials Overview 199

Prognostic Tool – ER+ Breast Cancer – Product Status 199

Prognostic Tool – ER+ Breast Cancer – Product Description 199

RealSeq Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 200

RealSeq-SC – Product Status 200

RealSeq-SC – Product Description 200

Rhodx Inc Pipeline Products & Ongoing Clinical Trials Overview 201

Liquid Biopsy Test – Cancer – Product Status 201

Liquid Biopsy Test – Cancer – Product Description 201

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 202

AVENIO Blood Test – Product Status 202

AVENIO Blood Test – Product Description 202

AVENIO Tissue Test – Product Status 202

AVENIO Tissue Test – Product Description 203

SeqOne SAS Pipeline Products & Ongoing Clinical Trials Overview 204

SeqOne HRD Test – Product Status 204

SeqOne HRD Test – Product Description 204

Silicon Biosystems S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 205

Genomic Cancer Assay – Product Status 205

Genomic Cancer Assay – Product Description 205

Sophia Genetics SA Pipeline Products & Ongoing Clinical Trials Overview 206

Myeloid Solution – Product Status 206

Myeloid Solution – Product Description 206

SOPHiA DDM Dx RNAtarget Oncology Solution – Product Status 207

SOPHiA DDM Dx RNAtarget Oncology Solution – Product Description 207

Sostos LLC Pipeline Products & Ongoing Clinical Trials Overview 208

CATOS-LU – Product Status 208

CATOS-LU – Product Description 208

Spectrum Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 209

Liquid Biopsy Test – Lung Cancer – Product Status 209

Liquid Biopsy Test – Lung Cancer – Product Description 209

Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 210

Next Generation Sequencing Based Companion Diagnostic Assay – Product Status 210

Next Generation Sequencing Based Companion Diagnostic Assay – Product Description 210

Sysmex Inostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 211

OncoBEAM – Hepatocellular Carcinoma – Product Status 211

OncoBEAM – Hepatocellular Carcinoma – Product Description 211

Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview 212

xT-Onco Assay – Product Status 212

xT-Onco Assay – Product Description 212

Tempus Health Inc – Ongoing Clinical Trials Overview 213

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 214

Tempus Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 215

xR IVD – Product Status 215

xR IVD – Product Description 215

Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 217

Companion Next-Generation Sequencing Oncology Test – Product Status 217

Companion Next-Generation Sequencing Oncology Test – Product Description 217

Next Generation Sequencing Assay – Breast Cancer – Product Status 218

Next Generation Sequencing Assay – Breast Cancer – Product Description 218

Next Generation Sequencing Assay – Pancreatic Cancer – Product Status 218

Next Generation Sequencing Assay – Pancreatic Cancer – Product Description 219

Next Generation Sequencing Assay – Prostate Cancer – Product Status 219

Next Generation Sequencing Assay – Prostate Cancer – Product Description 219

NGS Panel – Pediatric Cancer – Product Status 220

NGS Panel – Pediatric Cancer – Product Description 220

Oncomine Precision Assay – Non-Small Cell Lung Cancer – Product Status 220

Oncomine Precision Assay – Non-Small Cell Lung Cancer – Product Description 220

Oncomine Precision Assay – Solid Tissue Tumor – Product Status 221

Oncomine Precision Assay – Solid Tissue Tumor – Product Description 221

Thermo Fisher Scientific Inc – Ongoing Clinical Trials Overview 222

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 Non-small Cell Lung Cancer within the Exactis Network 223

Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

NGS Based Test – Cancer – Product Status 224

NGS Based Test – Cancer – Product Description 224

TwinStrand Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 225

TwinStrand DuplexSeq – Product Status 225

TwinStrand DuplexSeq – Product Description 225

University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 226

Oral Cancer Saliva Test – Product Status 226

Oral Cancer Saliva Test – Product Description 226

University of Michigan Rogel Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 227

UPSeq Test – Product Status 227

UPSeq Test – Product Description 227

Figures

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 22

Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 23

Next Generation Sequencing (NGS) Tests – Pipeline Products by Regulatory Path 24

Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 25

Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 26

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