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

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Next Generation Sequencing (NGS) Tests Pipeline Market Report Overview

Next-generation sequencing (NGS) refers to high-throughput methods for DNA sequencing that are not Sanger-based. This technology has largely superseded Sanger sequencing in academic or genome research and is increasingly being applied in clinical practice. The Next Generation Sequencing (NGS) Tests pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Territories ·        The US

·        China

·        Europe

·        South Korea

·        Japan

Key Regulatory Paths ·        NMPA

·        510(k)

·        PMA

·        CE-IVD

·        MDITAC

Leading Companies ·        4bases SA

·        AccuraGen Inc

·        ACT Genomics Co LTD

·        Adaptive Biotechnologies Corp

·        Almac Diagnostic Services Ltd

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Next Generation Sequencing (NGS) Tests Pipeline Market Segmentation by Territories

A few of the key territories for Next Generation Sequencing (NGS) tests pipeline products are the US, China, Europe, South Korea, and Japan. As of December 2023, the US accounted for the highest number of pipeline products.

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Territories, 2023 (%)

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Territories, 2023 (%)

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Next Generation Sequencing (NGS) Tests Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths followed by the Next Generation Sequencing (NGS) tests pipeline market are NMPA, 510(k), PMA, CE-IVD, and MDITAC. As of December 2023, NMPA was the most followed pathway for pipeline products in the market.

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Next Generation Sequencing (NGS) Tests Pipeline Market – Competitive Landscape

A few of the key companies associated with the Next Generation Sequencing (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: AccuraGen is headquartered in the US and has a presence in China as well.  It develops blood tests that sequence cell-free DNA (cfDNA) to provide sensitive and accurate cancer diagnostics facilitating more personalized cancer treatment. It provides molecular and bioinformatics technologies.

ACT Genomics Co Ltd: ACT Genomics is headquartered in Taipei, Taiwan. The company has an operational presence in Hong Kong, Singapore, and Japan as well. It develops solutions that provide treatment instructions for solid tumors, drug resistance, cancer monitoring, risk assessment, and immunotherapy evaluation. ACT Genomics offers biomarker discovery, patient stratification, consultation, and companion diagnostic (CDx) development services.

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Companies, 2023

Next Generation Sequencing (NGS) Tests Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Next Generation Sequencing (NGS) Tests Pipeline Market Territories Outlook

  • The US
  • China
  • Europe
  • South Korea
  • Japan

Next Generation Sequencing (NGS) Tests Pipeline Market Regulatory Paths Outlook

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

Scope

This report provides:

  • Extensive coverage of the Next Generation Sequencing (NGS) Tests under development.
  • 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 Next Generation Sequencing (NGS) tests 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

The report will enable 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 a 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.
  • Carry out 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
Cerba HealthCare SAS
DCGen Co Ltd
Eiken Chemical Co Ltd
Epic Sciences Inc
Epigenomics AG
First Genetics JCS
Flomics Biotech
Foundation Medicine Inc
Freenome 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 Technologies Inc
IvyGene Diagnostics
Laboratory Corp of America Holdings
Leto Laboratories Co Ltd
Lucence Diagnostics Pte Ltd
MedySapiens Inc
Mega Genomics Ltd
MolecularMD Corp
NGeneBio Co Ltd
Novigenix SA
Novomics Co Ltd
NuGEN Technologies Inc
NuProbe Inc
Oncodiag
OncoDNA SA
OncoSpire Genomics
OncXerna Therapeutics Inc
OrigiMed Inc
Otsuka Medical Devices Co Ltd
Pasteur Institute
Personal Genome Diagnostics Inc
Pillar Biosciences Inc
Predicine Inc
Predictive Biosciences Inc (Inactive)
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
Spectrum Solutions LLC
Sysmex Corp
Sysmex Inostics GmbH
Tempus Health 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
Vyant Bio Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 9

|1.2 List of Figures 18

2 Introduction 19

2.1 Next Generation Sequencing (NGS) Tests Overview 19

3 Products under Development 20

3.1 Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 20

3.2 Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 21

3.3 Next Generation Sequencing (NGS) Tests – Pipeline Products by Regulatory Path 22

3.4 Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 23

3.5 Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 24

4 Next Generation Sequencing (NGS) Tests – Pipeline Products under Development by Companies 25

4.1 Next Generation Sequencing (NGS) Tests Companies – Pipeline Products by Stage of Development 25

4.2 Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 29

5 Next Generation Sequencing (NGS) Tests Companies and Product Overview 34

5.1 4bases SA Company Overview 34

5.1.1 4bases SA Pipeline Products & Ongoing Clinical Trials Overview 34

5.2 AccuraGen Inc Company Overview 36

5.2.1 AccuraGen Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.3 ACT Genomics Co LTD Company Overview 37

5.3.1 ACT Genomics Co LTD Pipeline Products & Ongoing Clinical Trials Overview 37

5.4 Adaptive Biotechnologies Corp Company Overview 38

5.4.1 Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 38

5.5 Almac Diagnostic Services Ltd Company Overview 40

5.5.1 Almac Diagnostic Services Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.6 Amoy Diagnostics Co Ltd Company Overview 42

5.6.1 Amoy Diagnostics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

5.7 AnchorDx Medical Co Ltd Company Overview 43

5.7.1 AnchorDx Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

5.8 ArcherDx Inc Company Overview 46

5.8.1 ArcherDx Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Berry Oncology Corp Company Overview 50

5.9.1 Berry Oncology Corp Pipeline Products & Ongoing Clinical Trials Overview 50

5.10 BGI Genomics Co Ltd Company Overview 51

5.10.1 BGI Genomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.11 Biocartis Group NV Company Overview 52

5.11.1 Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 52

5.12 Biodesix Inc Company Overview 54

5.12.1 Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.13 BioLink Company Overview 56

5.13.1 BioLink Pipeline Products & Ongoing Clinical Trials Overview 56

5.14 bioTheranostics Inc Company Overview 57

5.14.1 bioTheranostics Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.15 Boston University Company Overview 58

5.15.1 Boston University Pipeline Products & Ongoing Clinical Trials Overview 58

5.16 Buhlmann Laboratories AG Company Overview 59

5.16.1 Buhlmann Laboratories AG Pipeline Products & Ongoing Clinical Trials Overview 59

5.17 Burning Rock Biotech Ltd Company Overview 61

5.17.1 Burning Rock Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

5.18 Cardiff Oncology Inc Company Overview 67

5.18.1 Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 67

5.19 Cerba HealthCare SAS Company Overview 68

5.19.1 Cerba HealthCare SAS Pipeline Products & Ongoing Clinical Trials Overview 68

5.20 DCGen Co Ltd Company Overview 69

5.20.1 DCGen Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.21 Eiken Chemical Co Ltd Company Overview 71

5.21.1 Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

5.22 Epic Sciences Inc Company Overview 72

5.22.1 Epic Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 72

5.23 Epigenomics AG Company Overview 73

5.23.1 Epigenomics AG Pipeline Products & Ongoing Clinical Trials Overview 73

5.24 First Genetics JCS Company Overview 78

5.24.1 First Genetics JCS Pipeline Products & Ongoing Clinical Trials Overview 78

5.25 Flomics Biotech Company Overview 79

5.25.1 Flomics Biotech Pipeline Products & Ongoing Clinical Trials Overview 79

5.26 Foundation Medicine Inc Company Overview 81

5.26.1 Foundation Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.27 Freenome Inc Company Overview 83

5.27.1 Freenome Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.28 Gencurix Inc Company Overview 86

5.28.1 Gencurix Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.29 GeneCast Biotechnology Co Ltd Company Overview 87

5.29.1 GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

5.30 Geneseeq Technology Inc Company Overview 94

5.30.1 Geneseeq Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.31 Genetron Health (Beijing) Co Ltd Company Overview 95

5.31.1 Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

5.32 Genomic Health Inc Company Overview 96

5.32.1 Genomic Health Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.33 GigaGen Inc Company Overview 98

5.33.1 GigaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 98

5.34 HaploX Biotechnology Co Ltd Company Overview 99

5.34.1 HaploX Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.35 Haystack Oncology Inc Company Overview 105

5.35.1 Haystack Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.36 HTG Molecular Diagnostics Inc Company Overview 108

5.36.1 HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.37 Illumina Inc Company Overview 110

5.37.1 Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.38 Immunovia AB Company Overview 118

5.38.1 Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 118

5.39 Inivata Ltd Company Overview 119

5.39.1 Inivata Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

5.40 Insight Genetics Inc Company Overview 126

5.40.1 Insight Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 126

5.41 InVivoScribe Technologies Inc Company Overview 127

5.41.1 InVivoScribe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 127

5.42 IvyGene Diagnostics Company Overview 131

5.42.1 IvyGene Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 131

5.43 Laboratory Corp of America Holdings Company Overview 136

5.43.1 Laboratory Corp of America Holdings Pipeline Products & Ongoing Clinical Trials Overview 136

5.44 Leto Laboratories Co Ltd Company Overview 138

5.44.1 Leto Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

5.45 Lucence Diagnostics Pte Ltd Company Overview 140

5.45.1 Lucence Diagnostics Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

5.46 MedySapiens Inc Company Overview 141

5.46.1 MedySapiens Inc Pipeline Products & Ongoing Clinical Trials Overview 141

5.47 Mega Genomics Ltd Company Overview 142

5.47.1 Mega Genomics Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

5.48 MolecularMD Corp Company Overview 146

5.48.1 MolecularMD Corp Pipeline Products & Ongoing Clinical Trials Overview 146

5.49 NGeneBio Co Ltd Company Overview 148

5.49.1 NGeneBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

5.50 Novigenix SA Company Overview 152

5.50.1 Novigenix SA Pipeline Products & Ongoing Clinical Trials Overview 152

5.51 Novomics Co Ltd Company Overview 155

5.51.1 Novomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 155

5.52 NuGEN Technologies Inc Company Overview 156

5.52.1 NuGEN Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.53 NuProbe Inc Company Overview 157

5.53.1 NuProbe Inc Pipeline Products & Ongoing Clinical Trials Overview 157

5.54 Oncodiag Company Overview 158

5.54.1 Oncodiag Pipeline Products & Ongoing Clinical Trials Overview 158

5.55 OncoDNA SA Company Overview 159

5.55.1 OncoDNA SA Pipeline Products & Ongoing Clinical Trials Overview 159

5.56 OncoSpire Genomics Company Overview 160

5.56.1 OncoSpire Genomics Pipeline Products & Ongoing Clinical Trials Overview 160

5.57 OncXerna Therapeutics Inc Company Overview 161

5.57.1 OncXerna Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 161

5.58 OrigiMed Inc Company Overview 162

5.58.1 OrigiMed Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.59 Otsuka Medical Devices Co Ltd Company Overview 163

5.59.1 Otsuka Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 163

5.60 Pasteur Institute Company Overview 165

5.60.1 Pasteur Institute Pipeline Products & Ongoing Clinical Trials Overview 165

5.61 Personal Genome Diagnostics Inc Company Overview 166

5.61.1 Personal Genome Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 166

5.62 Pillar Biosciences Inc Company Overview 168

5.62.1 Pillar Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 168

5.63 Predicine Inc Company Overview 171

5.63.1 Predicine Inc Pipeline Products & Ongoing Clinical Trials Overview 171

5.64 Predictive Biosciences Inc (Inactive) Company Overview 172

5.64.1 Predictive Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 172

5.65 Qiagen NV Company Overview 173

5.65.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 173

5.66 Quantgene Inc Company Overview 179

5.66.1 Quantgene Inc Pipeline Products & Ongoing Clinical Trials Overview 179

5.67 Queen’s University Company Overview 183

5.67.1 Queen’s University Pipeline Products & Ongoing Clinical Trials Overview 183

5.68 RealSeq Biosciences Inc Company Overview 184

5.68.1 RealSeq Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 184

5.69 Rhodx Inc Company Overview 185

5.69.1 Rhodx Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.70 Roche Diagnostics International Ltd Company Overview 186

5.70.1 Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

5.71 SeqOne SAS Company Overview 188

5.71.1 SeqOne SAS Pipeline Products & Ongoing Clinical Trials Overview 188

5.72 Silicon Biosystems S.p.A. Company Overview 189

5.72.1 Silicon Biosystems S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 189

5.73 Sophia Genetics SA Company Overview 190

5.73.1 Sophia Genetics SA Pipeline Products & Ongoing Clinical Trials Overview 190

5.74 Spectrum Solutions LLC Company Overview 192

5.74.1 Spectrum Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 192

5.75 Sysmex Corp Company Overview 193

5.75.1 Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 193

5.76 Sysmex Inostics GmbH Company Overview 194

5.76.1 Sysmex Inostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 194

5.77 Tempus Health Inc Company Overview 195

5.77.1 Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview 195

5.78 Thermo Fisher Scientific Inc Company Overview 198

5.78.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 198

5.79 Trivitron Healthcare Pvt Ltd Company Overview 206

5.79.1 Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

5.80 TwinStrand Biosciences Inc Company Overview 209

5.80.1 TwinStrand Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 209

5.81 University of Chicago Company Overview 210

5.81.1 University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 210

5.82 University of Michigan Rogel Cancer Center Company Overview 211

5.82.1 University of Michigan Rogel Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 211

5.83 University of Texas Health Science Center at Houston Company Overview 212

5.83.1 University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 212

5.84 Vyant Bio Inc Company Overview 213

5.84.1 Vyant Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 213

6 Next Generation Sequencing (NGS) Tests- Recent Developments 214

6.1 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 214

6.2 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 215

6.3 Dec 05, 2023: NeoGenomics to Present New Data at San Antonio Breast Cancer Symposium Highlighting Utility of RaDaR for Therapy Response 216

6.4 Dec 01, 2023: Strata Oncology Announces Presentations on Proprietary Multivariate Biomarkers at North America Conference on Lung Cancer and San Antonio Breast Cancer Symposium 217

6.5 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 218

6.6 Nov 20, 2023: Roswell Park Launches Advanced, High-Speed Blood Cancer Test 219

6.7 Nov 15, 2023: Tempus Announces Medicare Coverage for Tempus|xT Across Solid Tumor and Hematologic Malignancies 220

6.8 Nov 14, 2023: Castle Biosciences Announces Multiple Data Presentations at the 2023 American Society for Dermatologic Surgery Annual Meeting 220

6.9 Nov 06, 2023: Invitae Launches Enhanced Chemistry of MRD Test to Better Serve Biopharmaceutical Clinical and Research Partnerships 222

6.10 Oct 26, 2023: Foundation Medicine Announces Participation in National Cancer Institute’s ComboMATCH Initiative to Connect Patients with New Anti-Cancer Drug Combinations 223

6.11 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 224

6.12 Oct 19, 2023: Foundation Medicine Announces Acceptance of 11 Abstracts at the 2023 European Society for Medical Oncology (ESMO) Annual Meeting 225

6.13 Oct 18, 2023: New Data Highlights Clinical Utility and Performance of Castle Biosciences’ Dermatologic Test Portfolio at the 2023 Fall Clinical Dermatology Conference 226

6.14 Oct 17, 2023: Predicine Announces Six Studies Showcasing Mrd and Liquid Biopsy Innovations at ESMO 2023 228

6.15 Oct 15, 2023: Burning Rock Received Breakthrough Device Designation from China’s NMPA for its Multi-Cancer Early Detection Test 228

6.16 Oct 13, 2023: Geneseeq Receives Chinese NMPA Approval for Lung Cancer Tumor Mutational Burden NGS Test Kit 229

6.17 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 229

6.18 Oct 10, 2023: Karius Test Improves the Diagnosis and Management of Pneumonia in Patients Undergoing Treatment for Blood Cancer 230

6.19 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 231

6.20 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 232

6.21 Sep 28, 2023: New Neoadjuvant Trial Confirms the Predictive Utility of Mammaprint + Blueprint 233

6.22 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 234

6.23 Sep 19, 2023: Pillar Biosciences Launches oncoReveal Core LBx, an NGS Kit to Enable Localized Liquid Biopsy Testing 234

6.24 Sep 19, 2023: Myriad Genetics and Illumina Achieve Milestones in Strategic Partnership to Support Biopharma Clinical Trials 235

6.25 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 235

6.26 Aug 22, 2023: New Study Shows UroAmp Can Detect Bladder Cancer Not Found by Cystoscopy or Urine Cytology 236

6.27 Aug 22, 2023: Myriad Genetics And Onsite Women’s Health Partner To Help More Women Understand Breast Cancer Risk 237

6.28 Aug 22, 2023: Geneseeq Gains CE Marks For NGS-based Test Kits For Solid Tumors And Hematological Cancer 238

6.29 Aug 21, 2023: Scale Biosciences And Basepair To Democratize Single Cell Sequencing Data Analysis 238

6.30 Aug 16, 2023: 4BASES Announces the Readiness of a CFTR Mutations Detection Solution 239

6.31 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 239

6.32 Aug 02, 2023: Karius Test, a Liquid Biopsy for Infectious Diseases, Incorporated into Diagnostics Recommendation in the 2023 Duke-ISCVID Criteria for Infective Endocarditis 240

6.33 Jul 27, 2023: NeoGenomics Announces Medicare Coverage for RaDaR Assay for Minimal Residual Disease and Recurrence in Breast Cancer 241

6.34 Jul 24, 2023: Myriad Genetics Announces Inclusion of Breast Density to MyRisk with RiskScore Breast Cancer Risk Assessment 242

6.35 Jul 12, 2023: Tempus Announces the GEMINI Non-Small Cell Lung Cancer Study 242

6.36 Jul 04, 2023: China’s NMPA approves LAMH’s liver cancer detection test 243

6.37 Jun 30, 2023: Novigenix Reports Interim European Validation Data on Its New NGS-Based Whole Blood RNA Signature for Detection of Advanced Colorectal Adenomas 243

6.38 Jun 15, 2023: Neogenomics’ RaDaR Assay for Minimal Residual Disease Receives First Commercial Coverage 244

6.39 Jun 12, 2023: FDA approves FoundationOne Liquid CDx as companion diagnostic for Braftovi 245

6.40 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 245

6.41 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 246

6.42 Jun 08, 2023: Imbdx Expands Targeted Therapies Agreement Following Successful Evaluation of Blood-Based Genomic Profiling Assay in Prostate Cancer 246

6.43 Jun 08, 2023: Published in the New England Journal of Medicine 247

6.44 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 247

6.45 Jun 05, 2023: NeoGenomics and German Breast Group Announce New Data Demonstrating Clinical Potential of the RaDaR MRD Assay in HR+/HER2- Breast Cancer 248

6.46 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 249

6.47 Jun 01, 2023: Labcorp introduces new liquid biopsy test 250

6.48 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 251

6.49 May 30, 2023: NeoGenomics to showcase the transformational impact of RaDaR assay for molecular residual disease and recurrence monitoring at ASCO 252

6.50 May 26, 2023: Foundation Medicine and its collaborators announce acceptance of 21 Abstracts at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting 253

6.51 May 25, 2023: Digi7 launches Geneyx AI-based solution to analyse next-generation sequencing data at Mediclinic 260

6.52 May 23, 2023: Tempus Labs receives CLIA approval for xT CDx Test 260

6.53 May 11, 2023: Tempus Labs obtains Pre-Market Approval (PMA) for xT CDx Test 261

6.54 May 02, 2023: Tempus receives FDA approval for NGS-based test xT CDx 261

6.55 Apr 28, 2023: Predicine to introduce PredicineALERT MRD Assay and present two ctDNA studies in genitourinary cancers at AUA 2023 Annual Meeting 262

6.56 Apr 25, 2023: Strata Oncology announces launch and medicare coverage for Strata Select, a first-of-its-kind immunotherapy test 262

6.57 Apr 25, 2023: New Studies on Convergent Genomics’ Urine Test for Bladder Cancer to be Presented at 2023 American Urological Association (AUA) Annual Meeting 263

6.58 Apr 19, 2023: Epic Sciences announces medicare coverage for breast-cancer focused ctDNA Gene Panel 264

6.59 Apr 18, 2023: Myriad Genetics and Intermountain Precision Genomics now offer solid tumor testing in all 50 States with latest NY State Certification 264

6.60 Apr 17, 2023: Thermo Fisher Scientific Announces Oncomine Clinical Research Grant Awardees and Opens Spring 2023 Submissions 265

6.61 Apr 13, 2023: Myriad Genetics and SimonMed team up for genetic cancer risk programme 266

6.62 Apr 06, 2023: NeoGenomics to share nine abstracts at the American Association of Cancer Research (AACR) Annual Meeting 2023 266

6.63 Apr 03, 2023: Tempus announces second sequencing collaboration with Lilly to expand patient access to genomic testing 268

6.64 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 268

6.65 Mar 16, 2023: NeoGenomics announces commercial availability of the RaDaR Molecular Residual Disease Test 269

6.66 Mar 14, 2023: The Future Of Cancer Care: Next-Generation Sequencing Available at Cooperman Barnabas Medical Center 270

6.67 Mar 10, 2023: Castle Biosciences to highlight clinical value of its skin cancer tests at the 2023 American Academy of Dermatology (AAD) Annual Meeting 271

6.68 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 272

6.69 Mar 02, 2023: Point32Health and Foundation Medicine expand access to comprehensive genomic profiling for members with advanced cancer 273

6.70 Mar 02, 2023: Illumina and Myriad Genetics expand partnership to broaden access to HRD testing in the United States 274

6.71 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 275

6.72 Feb 21, 2023: iGene Laboratory announces launch of whole exome sequencing service 276

6.73 Feb 09, 2023: UnitedHealthcare provides commercial coverage for FoundationOne CDx and FoundationOne Liquid CDx in multiple companion diagnostic indications 276

6.74 Feb 07, 2023: Exact Sciences launches OncoExTra cancer therapy selection test in the U.S. 277

6.75 Feb 06, 2023: RaDaR(R) assay demonstrates clinical potential for helping Oncologists determine whether or not muscle-invasive bladder cancer patients undergo radical surgery 278

6.76 Jan 24, 2023: ACT Genomics receives CLIA approval for ACTOnco IVD Test 279

6.77 Jan 24, 2023: ACT Genomics receives CLIA approval for ACTOnco Test 279

6.78 Jan 10, 2023: Prenetics owned ACT Genomics receives FDA clearance for ACTOnco, the first Asia-based company to receive clearance for a comprehensive genomic profiling test for all solid tumors 279

6.79 Jan 03, 2023: ACT Genomics receives 510(k) clearance for ACTOnco IVD Test 280

6.80 Jan 03, 2023: ACT Genomics receives 510(k) clearance for ACTOnco Test 280

6.81 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 280

7 Appendix 282

7.1 Methodology 282

7.2 About GlobalData 285

7.3 Contact Us 285

7.4 Disclaimer 285

Table

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 20

Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 21

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

Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 23

Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 24

Next Generation Sequencing (NGS) Tests Companies – Pipeline Products by Stage of Development 25

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 29

4bases SA Pipeline Products & Ongoing Clinical Trials Overview 34

BRaVO Screen – Product Status 34

BRaVO Screen – Product Description 35

AccuraGen Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Firefly – Product Status 36

Firefly – Product Description 36

ACT Genomics Co LTD Pipeline Products & Ongoing Clinical Trials Overview 37

ACTSpot NTRK Test – Product Status 37

ACTSpot NTRK Test – Product Description 37

Adaptive Biotechnologies Corp Pipeline Products & Ongoing Clinical Trials Overview 38

ClonoSEQ Assay – Non-Hodgkin’s Lymphoma – Product Status 38

ClonoSEQ Assay – Non-Hodgkin’s Lymphoma – Product Description 39

Almac Diagnostic Services Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

Next-Generation Sequencing Based Companion Diagnostic Assay – Product Status 40

Next-Generation Sequencing Based Companion Diagnostic Assay – Product Description 40

Pan-Cancer Companion Diagnostic Assay – Product Status 41

Pan-Cancer Companion Diagnostic Assay – Product Description 41

Amoy Diagnostics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 42

AmoyDx LC10-Essential NGS Panel – Product Status 42

AmoyDx LC10-Essential NGS Panel – Product Description 42

AnchorDx Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

NGS-Based Multi-Cancer Screening Test – Product Status 43

NGS-Based Multi-Cancer Screening Test – Product Description 43

NGS-Based Pan-Cancer Panel – Product Status 44

NGS-Based Pan-Cancer Panel – Product Description 44

NGS-Based Single-Cancer Screening Test – Product Status 44

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

PulmoSeek Plus – Product Status 45

PulmoSeek Plus – Product Description 45

ArcherDx Inc Pipeline Products & Ongoing Clinical Trials Overview 46

AMP-Based Assay – Cancer – Product Status 46

AMP-Based Assay – Cancer – Product Description 46

NextSeq 550Dx System – Blood Cancer CDx Assay – Product Status 47

NextSeq 550Dx System – Blood Cancer CDx Assay – Product Description 47

NextSeq 550Dx System – Minimal Residual Disease Assay – Product Status 47

NextSeq 550Dx System – Minimal Residual Disease Assay – Product Description 48

NextSeq 550Dx System – Solid Tumor CDx Assay – Product Status 48

NextSeq 550Dx System – Solid Tumor CDx Assay – Product Description 48

NGS-Based Companion Diagnostic Assay – Cancer – Product Status 49

NGS-Based Companion Diagnostic Assay – Cancer – Product Description 49

Berry Oncology Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Lai Si Ning – Product Status 50

Lai Si Ning – Product Description 50

BGI Genomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

SENTIS Colorectal Cancer Panel – Liquid Biopsy Version – Product Status 51

SENTIS Colorectal Cancer Panel – Liquid Biopsy Version – Product Description 51

Biocartis Group NV Pipeline Products & Ongoing Clinical Trials Overview 52

Idylla NGS Prep Panel – Lung – Product Status 52

Idylla NGS Prep Panel – Lung – Product Description 52

Idylla Retrieve – NGS Hotspot Panel Assay – Product Status 53

Idylla Retrieve – NGS Hotspot Panel Assay – Product Description 53

Biodesix Inc Pipeline Products & Ongoing Clinical Trials Overview 54

52-Gene Panel Based Companion Diagnostic – Product Status 54

52-Gene Panel Based Companion Diagnostic – Product Description 54

TAm-Seq NGS Lung Cancer Test – Product Status 55

TAm-Seq NGS Lung Cancer Test – Product Description 55

BioLink Pipeline Products & Ongoing Clinical Trials Overview 56

Diagnostic Test – Breast Cancer – Product Status 56

Diagnostic Test – Breast Cancer – Product Description 56

bioTheranostics Inc Pipeline Products & Ongoing Clinical Trials Overview 57

CancerTREATMENT ID – Product Status 57

CancerTREATMENT ID – Product Description 57

Boston University Pipeline Products & Ongoing Clinical Trials Overview 58

Diagnostic Test – Esophageal Adenocarcinoma – Product Status 58

Diagnostic Test – Esophageal Adenocarcinoma – Product Description 58

Buhlmann Laboratories AG Pipeline Products & Ongoing Clinical Trials Overview 59

NGS Targeted Hotspot Panel 16 Kit – Product Status 59

NGS Targeted Hotspot Panel 16 Kit – Product Description 60

Burning Rock Biotech Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

OncoCompass Target CDx Test – Tepotinib – Product Status 61

OncoCompass Target CDx Test – Tepotinib – Product Description 62

OverC Multi-Cancer Detection Blood Test Kit – Product Status 62

OverC Multi-Cancer Detection Blood Test Kit – Product Description 62

Burning Rock Biotech Ltd – Ongoing Clinical Trials Overview 63

OverC Multi-Cancer Detection Blood Test Kit – A Prospective Multi-cancer Early-detection and Interventional Study in Asymptomatic Individuals: PREVENT 64

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) 64

OverC Multi-Cancer Detection Blood Test Kit – Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study 64

OverC Multi-Cancer Detection Blood Test Kit – Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study 65

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 65

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) 65

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 66

OverC Multi-Cancer Detection Blood Test Kit – Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: A Multi-center, Prospective Observational Study 66

Cardiff Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 67

Mutation Enrichment Kit – Product Status 67

Mutation Enrichment Kit – Product Description 67

Cerba HealthCare SAS Pipeline Products & Ongoing Clinical Trials Overview 68

Diagnostic Test – Cancer – Product Status 68

Diagnostic Test – Cancer – Product Description 68

DCGen Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

HOPE – Product Status 69

HOPE – Product Description 69

OncoFREE – Product Status 70

OncoFREE – Product Description 70

Eiken Chemical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 71

Companion Diagnostic Kit – Non-Small Cell Lung Cancer – Product Status 71

Companion Diagnostic Kit – Non-Small Cell Lung Cancer – Product Description 71

Epic Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 72

DefineMBC – Product Status 72

DefineMBC – Product Description 72

Epigenomics AG Pipeline Products & Ongoing Clinical Trials Overview 73

NGS Panel – Bladder Cancer – Product Status 73

NGS Panel – Bladder Cancer – Product Description 73

NGS Panel – Breast Cancer – Product Status 74

NGS Panel – Breast Cancer – Product Description 74

NGS Panel – Colon Cancer – Product Status 74

NGS Panel – Colon Cancer – Product Description 75

NGS Panel – Lung Cancer – Product Status 75

NGS Panel – Lung Cancer – Product Description 75

NGS Panel – Ovarian Cancer – Product Status 76

NGS Panel – Ovarian Cancer – Product Description 76

NGS Panel – Prostate Cancer – Product Status 76

NGS Panel – Prostate Cancer – Product Description 77

First Genetics JCS Pipeline Products & Ongoing Clinical Trials Overview 78

F-Genetics NGS System – Oncology – Product Status 78

F-Genetics NGS System – Oncology – Product Description 78

Flomics Biotech Pipeline Products & Ongoing Clinical Trials Overview 79

Colon Cancer Diagnostic Test – Product Status 79

Colon Cancer Diagnostic Test – Product Description 79

Lung Cancer Diagnostic Test – Product Status 80

Lung Cancer Diagnostic Test – Product Description 80

Foundation Medicine Inc Pipeline Products & Ongoing Clinical Trials Overview 81

FoundationOne CDx – BI 907828 – Product Status 81

FoundationOne CDx – BI 907828 – Product Description 82

FoundationOne CDx – Vitrakvi – Product Status 82

FoundationOne CDx – Vitrakvi – Product Description 82

Freenome Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Artificial Intelligence Based Companion Diagnostics – Colorectal Cancer – Product Status 83

Artificial Intelligence Based Companion Diagnostics – Colorectal Cancer – Product Description 83

Freenome Inc – Ongoing Clinical Trials Overview 84

Artificial Intelligence Based Companion Diagnostics – Colorectal Cancer – Prevention of Colorectal Cancer Through Multiomics Blood Testing 85

Artificial Intelligence Based Companion Diagnostics – Colorectal Cancer – The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening 85

Gencurix Inc Pipeline Products & Ongoing Clinical Trials Overview 86

NGS (Next Generation Sequencing) Cancer Test – Product Status 86

NGS (Next Generation Sequencing) Cancer Test – Product Description 86

GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

Genecast IVD – Comprehensive – Product Status 87

Genecast IVD – Comprehensive – Product Description 88

Genecast IVD – ctDNA Focus – Product Status 88

Genecast IVD – ctDNA Focus – Product Description 89

Genecast IVD – Early Detection Multi-Cancer – Product Status 89

Genecast IVD – Early Detection Multi-Cancer – Product Description 90

Genecast IVD – KNBP – Melanoma – Product Status 90

Genecast IVD – KNBP – Melanoma – Product Description 90

Genecast IVD – MammaPrint – Product Status 91

Genecast IVD – MammaPrint – Product Description 91

Genecast IVD – MRD Solid Tumors – Product Status 91

Genecast IVD – MRD Solid Tumors – Product Description 92

Genecast IVD – RNA Fusion Focus – Product Status 92

Genecast IVD – RNA Fusion Focus – Product Description 93

Geneseeq Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Comprehensive Cancer NGS Diagnostic Kit – Product Status 94

Comprehensive Cancer NGS Diagnostic Kit – Product Description 94

Genetron Health (Beijing) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 95

Blood-Based Lung EGFR NGS IVD Assay – Product Status 95

Blood-Based Lung EGFR NGS IVD Assay – Product Description 95

Genomic Health Inc Pipeline Products & Ongoing Clinical Trials Overview 96

Liquid Biopsy-Based Bladder Cancer Test – Product Status 96

Liquid Biopsy-Based Bladder Cancer Test – Product Description 96

Next Generation Sequencing Oncotype DX – Prostate Cancer Assay – Product Status 97

Next Generation Sequencing Oncotype DX – Prostate Cancer Assay – Product Description 97

GigaGen Inc Pipeline Products & Ongoing Clinical Trials Overview 98

GigaMune HemeOnc – Product Status 98

GigaMune HemeOnc – Product Description 98

HaploX Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

HaploX AiScreening Pan-cancer Early Screening Testing Kit – IVD – Product Status 99

HaploX AiScreening Pan-cancer Early Screening Testing Kit – IVD – Product Description 100

HaploX AiScreening Pan-cancer Early Screening Testing Kit – LDT – Product Status 100

HaploX AiScreening Pan-cancer Early Screening Testing Kit – LDT – Product Description 100

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – IVD – Product Status 101

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – IVD – Product Description 101

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – LDT – Product Status 101

HaploX PulmoScope Pulmonary Nodule Diagnosis Testing Kit – LDT – Product Description 102

HaploX UrineScope Urological Tumor Screening Testing Kit – IVD – Product Status 102

HaploX UrineScope Urological Tumor Screening Testing Kit – IVD – Product Description 102

HaploX UrineScope Urological Tumor Screening Testing Kit – LDT – Product Status 103

HaploX UrineScope Urological Tumor Screening Testing Kit – LDT – Product Description 103

HapOnco PharmCDx NGS Testing Kit – Product Status 103

HapOnco PharmCDx NGS Testing Kit – Product Description 104

HapOnco WESPlus NGS Testing Kit – Pan Cancer – Product Status 104

HapOnco WESPlus NGS Testing Kit – Pan Cancer – Product Description 104

Haystack Oncology Inc Pipeline Products & Ongoing Clinical Trials Overview 105

MRD Test – Breast Cancer – Product Status 105

MRD Test – Breast Cancer – Product Description 105

MRD Test – Colorectal Cancer – Product Status 106

MRD Test – Colorectal Cancer – Product Description 106

MRD Test – Lung Cancer – Product Status 106

MRD Test – Lung Cancer – Product Description 107

HTG Molecular Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

CNV Navigator – Product Status 108

CNV Navigator – Product Description 109

Ion PGM Dx System – Cancer Assay – Product Status 109

Ion PGM Dx System – Cancer Assay – Product Description 109

Illumina Inc Pipeline Products & Ongoing Clinical Trials Overview 110

Companion Diagnostic Test – Oncology – Product Status 110

Companion Diagnostic Test – Oncology – Product Description 111

TruSight Oncology 500 – TP53 CDx Assay – Product Status 111

TruSight Oncology 500 – TP53 CDx Assay – Product Description 111

TruSight Oncology 500 HRD – Product Status 112

TruSight Oncology 500 HRD – Product Description 112

TruSight Oncology Comprehensive – Product Status 112

TruSight Oncology Comprehensive – Product Description 113

TruSight Tumor 170 CDx – LOXO-101 – Product Status 113

TruSight Tumor 170 CDx – LOXO-101 – Product Description 113

TruSight Tumor 170 CDx – LOXO-292 – Product Status 114

TruSight Tumor 170 CDx – LOXO-292 – Product Description 114

Illumina Inc – Ongoing Clinical Trials Overview 115

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) 116

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 117

Immunovia AB Pipeline Products & Ongoing Clinical Trials Overview 118

ProMIS Assay – Product Status 118

ProMIS Assay – Product Description 118

Inivata Ltd Pipeline Products & Ongoing Clinical Trials Overview 119

InVision ctDNA Assay – EGFR-Mutant NSCLC – Product Status 119

InVision ctDNA Assay – EGFR-Mutant NSCLC – Product Description 120

InVision ctDNA Assay – Metastatic Breast Cancer – Product Status 120

InVision ctDNA Assay – Metastatic Breast Cancer – Product Description 120

InVision ctDNA Assay – NSCLC – Product Status 121

InVision ctDNA Assay – NSCLC – Product Description 121

InVision ctDNA Assay – Pancreatic Cancer – Product Status 121

InVision ctDNA Assay – Pancreatic Cancer – Product Description 122

InVision ctDNA Assay – Stage III/IV NSCLC – Product Status 122

InVision ctDNA Assay – Stage III/IV NSCLC – Product Description 122

RaDaR Assay – Product Status 123

RaDaR Assay – Product Description 123

Inivata Ltd – Ongoing Clinical Trials Overview 124

RaDaR Assay – Liquid Biopsy for Minimal Residual Disease Detection in Head and Necksquamous Cell Carcinoma (LIONESS) Study 125

RaDaR Assay – SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) – a Partially Double-blinded, Multi-center, Randomized, Controlled Superiority Study 125

Insight Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 126

NGS Lung Panel Test – Product Status 126

NGS Lung Panel Test – Product Description 126

InVivoScribe Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 127

B-cell Immuno-Oncology Assay Kit – Product Status 127

B-cell Immuno-Oncology Assay Kit – Product Description 128

LymphoTrack Dx TRB Assay – PGM – Product Status 128

LymphoTrack Dx TRB Assay – PGM – Product Description 128

MiSeqDx – Cancer Diagnostic Test – Product Status 129

MiSeqDx – Cancer Diagnostic Test – Product Description 129

NGS Based Hematologic Malignancy Test – Product Status 129

NGS Based Hematologic Malignancy Test – Product Description 130

T-cell Immuno-Oncology Assay Kit – Product Status 130

T-cell Immuno-Oncology Assay Kit – Product Description 130

IvyGene Diagnostics Pipeline Products & Ongoing Clinical Trials Overview 131

IvyGene Test – Brain Cancer – Product Status 131

IvyGene Test – Brain Cancer – Product Description 131

IvyGene Test – Breast Cancer – Product Status 132

IvyGene Test – Breast Cancer – Product Description 132

IvyGene Test – Colorectal Cancer – Product Status 132

IvyGene Test – Colorectal Cancer – Product Description 133

IvyGene Test – Lung Cancer – Product Status 133

IvyGene Test – Lung Cancer – Product Description 133

IvyGene Test – Nasopharyngeal Carcinoma – Product Status 134

IvyGene Test – Nasopharyngeal Carcinoma – Product Description 134

IvyGene Test – Ovarian Cancer – Product Status 134

IvyGene Test – Ovarian Cancer – Product Description 135

IvyGene Test – Pancreatic Cancer – Product Status 135

IvyGene Test – Pancreatic Cancer – Product Description 135

Laboratory Corp of America Holdings Pipeline Products & Ongoing Clinical Trials Overview 136

IntelliGEN Myeloid Test – Product Status 136

IntelliGEN Myeloid Test – Product Description 137

Leto Laboratories Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

Companion Diagnostic Test – Solid Tumors – Product Status 138

Companion Diagnostic Test – Solid Tumors – Product Description 138

Prognostic Test – Solid Tumor Immunotherapy – Product Status 139

Prognostic Test – Solid Tumor Immunotherapy – Product Description 139

Lucence Diagnostics Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

Lymphoma Subtype Test – Product Status 140

Lymphoma Subtype Test – Product Description 140

MedySapiens Inc Pipeline Products & Ongoing Clinical Trials Overview 141

NEOseq_Cancer – Product Status 141

NEOseq_Cancer – Product Description 141

Mega Genomics Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

BRCA1/BRCA2 Gene Mutation Diagnostic Kit – Product Status 142

BRCA1/BRCA2 Gene Mutation Diagnostic Kit – Product Description 142

Cervical Cancer Screening Kit – Product Status 143

Cervical Cancer Screening Kit – Product Description 143

Colorectal Cancer Screening Kit – Product Status 143

Colorectal Cancer Screening Kit – Product Description 144

Gastric Cancer Screening Kit – Product Status 144

Gastric Cancer Screening Kit – Product Description 144

Lung Nodule Auxiliary Diagnostic Kit – Product Status 145

Lung Nodule Auxiliary Diagnostic Kit – Product Description 145

MolecularMD Corp Pipeline Products & Ongoing Clinical Trials Overview 146

NGS Assay – Lung Cancer – Product Status 146

NGS Assay – Lung Cancer – Product Description 146

Notch1 NGS Test – Chronic Lymphocytic Leukemia – Product Status 147

Notch1 NGS Test – Chronic Lymphocytic Leukemia – Product Description 147

NGeneBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

BRCA NGS Panel For PARP Inhibitor CDx Test – Product Status 148

BRCA NGS Panel For PARP Inhibitor CDx Test – Product Description 149

LUNGaccuTest – Product Status 149

LUNGaccuTest – Product Description 149

ONCOaccu Panel – Product Status 150

ONCOaccu Panel – Product Description 150

SOLIDaccuCDx SOMATIC – Product Status 150

SOLIDaccuCDx SOMATIC – Product Description 151

SOLIDaccuTest – Product Status 151

SOLIDaccuTest – Product Description 151

Novigenix SA Pipeline Products & Ongoing Clinical Trials Overview 152

LITOSeekColon – Product Status 152

LITOSeekColon – Product Description 152

LITOseekColonMon – Product Status 153

LITOseekColonMon – Product Description 153

LITOSeekProstate – Product Status 153

LITOSeekProstate – Product Description 154

Precision Diagnostic Test – Neuroendocrine Tumor – Product Status 154

Precision Diagnostic Test – Neuroendocrine Tumor – Product Description 154

Novomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 155

Companion Diagnostic Test – Lung Cancer – Product Status 155

Companion Diagnostic Test – Lung Cancer – Product Description 155

NuGEN Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 156

Epigenetic Test – Cancer – Product Status 156

Epigenetic Test – Cancer – Product Description 156

NuProbe Inc Pipeline Products & Ongoing Clinical Trials Overview 157

Liquid Biopsy NGS Panel – Non-Small Cell Lung Cancer – Product Status 157

Liquid Biopsy NGS Panel – Non-Small Cell Lung Cancer – Product Description 157

Oncodiag Pipeline Products & Ongoing Clinical Trials Overview 158

Prostadiag – Product Status 158

Prostadiag – Product Description 158

OncoDNA SA Pipeline Products & Ongoing Clinical Trials Overview 159

Companion Diagnostic Assay – Tipifarnib – Product Status 159

Companion Diagnostic Assay – Tipifarnib – Product Description 159

OncoSpire Genomics Pipeline Products & Ongoing Clinical Trials Overview 160

Next-Generation Sequencing Test – Lung Cancer – Product Status 160

Next-Generation Sequencing Test – Lung Cancer – Product Description 160

OncXerna Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 161

Xerna TME Companion Diagnostic Assay – Ovarian Cancer – Product Status 161

Xerna TME Companion Diagnostic Assay – Ovarian Cancer – Product Description 161

OrigiMed Inc Pipeline Products & Ongoing Clinical Trials Overview 162

NGS-Based CDx – Larotrectinib – Product Status 162

NGS-Based CDx – Larotrectinib – Product Description 162

Otsuka Medical Devices Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 163

NextSeq 550Dx System – Acute Lymphoblastic Leukemia Assay – Product Status 163

NextSeq 550Dx System – Acute Lymphoblastic Leukemia Assay – Product Description 163

NextSeq 550Dx System – Acute Myeloid Leukemia Assay – Product Status 164

NextSeq 550Dx System – Acute Myeloid Leukemia Assay – Product Description 164

Pasteur Institute Pipeline Products & Ongoing Clinical Trials Overview 165

HPV RNA-Seq Test – Product Status 165

HPV RNA-Seq Test – Product Description 165

Personal Genome Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 166

PGDx elio Plasma Resolve – Product Status 166

PGDx elio Plasma Resolve – Product Description 166

Precision Diagnostics Tool – Product Status 167

Precision Diagnostics Tool – Product Description 167

Pillar Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 168

IVD Onco/Reveal Dx Assay – Blood Cancer – Product Status 168

IVD Onco/Reveal Dx Assay – Blood Cancer – Product Description 168

IVD Onco/Reveal Dx Assay – Liquid Biopsy – Product Status 169

IVD Onco/Reveal Dx Assay – Liquid Biopsy – Product Description 169

IVD Onco/Reveal Dx Assay – Tumor Tissue Testing – Product Status 169

IVD Onco/Reveal Dx Assay – Tumor Tissue Testing – Product Description 170

Predicine Inc Pipeline Products & Ongoing Clinical Trials Overview 171

PredicineCARE Companion Diagnostic Test – Product Status 171

PredicineCARE Companion Diagnostic Test – Product Description 171

Predictive Biosciences Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 172

CertNDx Bladder Cancer Assay – TP53 – Product Status 172

CertNDx Bladder Cancer Assay – TP53 – Product Description 172

Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 173

Companion Diagnostic Assay – Precancerous Cervical Lesions – Product Status 173

Companion Diagnostic Assay – Precancerous Cervical Lesions – Product Description 174

GeneRead QIAact Lung All-in-One Assay – Product Status 174

GeneRead QIAact Lung All-in-One Assay – Product Description 174

GeneReader NGS System – BRCA Liquid Biopsy Assay – Product Status 175

GeneReader NGS System – BRCA Liquid Biopsy Assay – Product Description 175

GeneReader NGS System – Leukemia – Product Status 175

GeneReader NGS System – Leukemia – Product Description 176

GeneReader NGS System – MPN – Product Status 176

GeneReader NGS System – MPN – Product Description 176

QIAact Breast Panel (Expanded) – Product Status 177

QIAact Breast Panel (Expanded) – Product Description 177

QIAact Lung Panel (CNV And Fusion) – Product Status 177

QIAact Lung Panel (CNV And Fusion) – Product Description 178

QIAact Onco-Heme Panel – Myeloid – Product Status 178

QIAact Onco-Heme Panel – Myeloid – Product Description 178

Quantgene Inc Pipeline Products & Ongoing Clinical Trials Overview 179

DEEPGEN Panel – Product Status 179

DEEPGEN Panel – Product Description 180

Liquid Biopsy Assay – Cancer Recurrence Monitoring – Product Status 181

Liquid Biopsy Assay – Cancer Recurrence Monitoring – Product Description 181

Liquid Biopsy Assay – Minimum Residual Disease – Product Status 181

Liquid Biopsy Assay – Minimum Residual Disease – Product Description 182

Liquid Biopsy Companion Diagnostic Assay – Product Status 182

Liquid Biopsy Companion Diagnostic Assay – Product Description 182

Queen’s University Pipeline Products & Ongoing Clinical Trials Overview 183

Prognostic Tool – ER+ Breast Cancer – Product Status 183

Prognostic Tool – ER+ Breast Cancer – Product Description 183

RealSeq Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 184

RealSeq-SC – Product Status 184

RealSeq-SC – Product Description 184

Rhodx Inc Pipeline Products & Ongoing Clinical Trials Overview 185

Liquid Biopsy Test – Cancer – Product Status 185

Liquid Biopsy Test – Cancer – Product Description 185

Roche Diagnostics International Ltd Pipeline Products & Ongoing Clinical Trials Overview 186

AVENIO Blood Test – Product Status 186

AVENIO Blood Test – Product Description 186

AVENIO Tissue Test – Product Status 187

AVENIO Tissue Test – Product Description 187

SeqOne SAS Pipeline Products & Ongoing Clinical Trials Overview 188

SeqOne HRD Test – Product Status 188

SeqOne HRD Test – Product Description 188

Silicon Biosystems S.p.A. Pipeline Products & Ongoing Clinical Trials Overview 189

Genomic Cancer Assay – Product Status 189

Genomic Cancer Assay – Product Description 189

Sophia Genetics SA Pipeline Products & Ongoing Clinical Trials Overview 190

Myeloid Solution – Product Status 190

Myeloid Solution – Product Description 190

SOPHiA DDM Dx RNAtarget Oncology Solution – Product Status 191

SOPHiA DDM Dx RNAtarget Oncology Solution – Product Description 191

Spectrum Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 192

Liquid Biopsy Test – Lung Cancer – Product Status 192

Liquid Biopsy Test – Lung Cancer – Product Description 192

Sysmex Corp Pipeline Products & Ongoing Clinical Trials Overview 193

Next Generation Sequencing Based Companion Diagnostic Assay – Product Status 193

Next Generation Sequencing Based Companion Diagnostic Assay – Product Description 193

Sysmex Inostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 194

OncoBEAM – Hepatocellular Carcinoma – Product Status 194

OncoBEAM – Hepatocellular Carcinoma – Product Description 194

Tempus Health Inc Pipeline Products & Ongoing Clinical Trials Overview 195

xT-Onco Assay – Product Status 195

xT-Onco Assay – Product Description 195

Tempus Health Inc – Ongoing Clinical Trials Overview 196

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 197

Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 198

Companion Next-Generation Sequencing Oncology Test – Product Status 198

Companion Next-Generation Sequencing Oncology Test – Product Description 199

Next Generation Sequencing Assay – Breast Cancer – Product Status 199

Next Generation Sequencing Assay – Breast Cancer – Product Description 199

Next Generation Sequencing Assay – Pancreatic Cancer – Product Status 200

Next Generation Sequencing Assay – Pancreatic Cancer – Product Description 200

Next Generation Sequencing Assay – Prostate Cancer – Product Status 200

Next Generation Sequencing Assay – Prostate Cancer – Product Description 201

NGS Panel – Pediatric Cancer – Product Status 201

NGS Panel – Pediatric Cancer – Product Description 201

Oncomine Dx Target Test – BLU-667 – Product Status 202

Oncomine Dx Target Test – BLU-667 – Product Description 202

Oncomine Precision Assay – Non-Small Cell Lung Cancer – Product Status 202

Oncomine Precision Assay – Non-Small Cell Lung Cancer – Product Description 203

Oncomine Precision Assay – Solid Tissue Tumor – Product Status 203

Oncomine Precision Assay – Solid Tissue Tumor – Product Description 203

Thermo Fisher Scientific Inc – Ongoing Clinical Trials Overview 204

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 205

Trivitron Healthcare Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 206

NGS Based Test – Cancer – Product Status 206

NGS Based Test – Cancer – Product Description 206

NGS Based Test – Infectious Diseases – Product Status 207

NGS Based Test – Infectious Diseases – Product Description 207

NGS Based Test – Prenatal Diseases – Product Status 207

NGS Based Test – Prenatal Diseases – Product Description 208

TwinStrand Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 209

TwinStrand DuplexSeq – Product Status 209

TwinStrand DuplexSeq – Product Description 209

University of Chicago Pipeline Products & Ongoing Clinical Trials Overview 210

Oral Cancer Saliva Test – Product Status 210

Oral Cancer Saliva Test – Product Description 210

University of Michigan Rogel Cancer Center Pipeline Products & Ongoing Clinical Trials Overview 211

UPSeq Test – Product Status 211

UPSeq Test – Product Description 211

University of Texas Health Science Center at Houston Pipeline Products & Ongoing Clinical Trials Overview 212

Genomic DNA Mutation Assay – Product Status 212

Genomic DNA Mutation Assay – Product Description 212

Vyant Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 213

Cell Free DNA Assay – Kidney Cancer – Product Status 213

Cell Free DNA Assay – Kidney Cancer – Product Description 213

Glossary 284

Figures

Next Generation Sequencing (NGS) Tests – Pipeline Products by Stage of Development 20

Next Generation Sequencing (NGS) Tests – Pipeline Products by Territory 21

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

Next Generation Sequencing (NGS) Tests – Pipeline Products by Estimated Approval Date 23

Next Generation Sequencing (NGS) Tests – Ongoing Clinical Trials 24

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