COVID 19 Nucleic Acid Amplification Tests (NAATs) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2021

Pages: 234 Published: November 30, 2021 Report Code: GDME1271EPD

The nucleic acid amplification test (NAAT) involves the amplification of specific nucleic acid sequences of the SARS-CoV-2 virus by targeting specific nucleic acid sequences. NAAT exhibits better sensitivity in comparison to antigen identification methods. Multiple targets are used in PCR to detect the different types of SARS-CoV-2. One unit refers to one NAAT test. The COVID-19 nucleic acid amplification tests pipeline product market report provides comprehensive information about the pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

What is the territory outlook of the COVID-19 nucleic acid amplification tests pipeline products market?

The US accounts for the highest number of COVID-19 NAAT pipeline products in the market followed by Canada and Europe. The other top territories include India, China, Brazil, Indonesia, Israel, Japan, Kuwait, Malaysia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Argentina, Ecuador, Mexico, Peru, Russia, Uruguay, and Vietnam.

COVID-19 NAAT pipeline product market, by territory

COVID-19 NAAT pipeline product market, by territory

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What are the different stages in the COVID-19 nucleic acid amplification tests pipeline products market?

The maximum number of pipeline products in the market is in the approval process. Both early development and clinical stages have nearly 40 products each and one of the products is in the inactive stage. EUA is the most popular regulatory path taken for the approval of COVID-19 NAAT pipeline products. One of the pipeline products will have approval in the first quarter of 2022.

COVID-19 NAAT pipeline product market, by stage of development

COVID-19 NAAT pipeline product market, by stage of development

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Which are the major companies in the COVID-19 nucleic acid amplification tests pipeline products market?

The key companies in the COVID-19 NAAT pipeline product market are 1drop Inc, 3D Medicines Inc, 4basebio AG, 8 Billion Inc, Aanika Biosciences Inc, Access Medical Labs, Acumen Research Laboratories Pte Ltd., Advanced MedTech Holdings Pte Ltd, Aegea Biotechnologies Inc, Agappe Diagnostics Ltd, Agena Bioscience Inc, Aldatu Biosciences Inc, Altona Diagnostic GmbH, American Biosources Inc, and Applied Biological Materials Inc.

1drop Inc: 1drop Inc (1drop) is a company that provides a healthcare solution that can help manage the patient’s health with just a single drop of blood. The company is headquartered in Seongnam-si, Gyeonggi, South Korea.

3D Medicines Inc: 3D Medicines Inc (3D Medicines) is a precision medicine company that provides cancer precision medical treatment. The company provides ANDiS SARS-CoV-2 detection kit and the ANDiS SARS-CoV-2 and influenza A/B detection kit. They also offer cancer diagnosis and treatment through the integration of biological characteristics, clinical diagnosis and treatment, and drug research and development data mining applications. It offers precision cancer prevention, precision cancer diagnosis, and precision drug development. 3D Medicines offers services for different people, which cover tumor tissue and blood samples. The company also operates in the field of drug development that covers immunotherapy and other biomarker-Driven targeting therapy.

4basebio AG: This company was formerly known as Expedeon AG. They are a developer of novel products and tools in the field of molecular biology. The company undertakes the development, manufacture, and marketing of gene therapies and DNA vaccines for DNA amplification and sequencing. Its offers products such development of highly efficient and scalable manufacturing processes of hp DNA for use in gene therapies and DNA vaccines, expansion of technologies and production capabilities for raw materials, expansion of technologies and systems to efficiently deliver DNA to target cells in patients. Its polymerases provide a wide range of applications for DNA amplification, repair, sequencing, detection, and modification of genetic targets of clinical value.

Acumen Research Laboratories Pte Ltd.: Acumen Research Laboratories Pte Ltd. (ARL) is a research organization that provides customized, contract R&D services in drug target discovery and pre-clinical drug development to support the pharmaceutical industry and related biomedical sciences research communities.

Aegea Biotechnologies Inc: Aegea Biotechnologies Inc (Aegea) is a biotechnology company that discovers and develops reagents, research kits, and in-vitro diagnostic (IVD) products for molecular analysis. Aegea is headquartered in San Diego, California, the US.

COVID-19 NAAT pipeline product market, by companyCOVID-19 NAAT pipeline product market, by company

To know more about key companies, download a free report sampl

Market report scope

Key territory The US, Canada, Europe, India, China, Brazil, Indonesia, Israel, Japan, Kuwait, Malaysia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Argentina, Ecuador, Mexico, Peru, Russia, Uruguay, and Vietnam
Key stage of development Early Development, Clinical, In-approval, and Inactive
Key regulatory path EUA, CE-IVD, 510(k), MDL, and NMPA
Key companies 1drop Inc, 3D Medicines Inc, 4basebio AG, 8 Billion Inc, Aanika Biosciences Inc, Access Medical Labs, Acumen Research Laboratories Pte Ltd., Advanced MedTech Holdings Pte Ltd, Aegea Biotechnologies Inc, Agappe Diagnostics Ltd, Agena Bioscience Inc, Aldatu Biosciences Inc, Altona Diagnostic GmbH, American Biosources Inc, and Applied Biological Materials Inc

This report provides an in-depth analysis of the following:

  • Extensive coverage of the COVID-19 nucleic acid amplification tests under development.
  • The report reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities.
  • Major players involved in the development of COVID-19 NAAT and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing 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 COVID-19 nucleic acid amplification tests under development.
  • Develop market entry and market expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Key Players

1drop Inc
3D Medicines Inc
4basebio AG
8 Billion Inc
Aanika Biosciences Inc
Access Medical Labs
Acumen Research Laboratories Pte Ltd.
Advanced MedTech Holdings Pte Ltd
Aegea Biotechnologies Inc
Agappe Diagnostics Ltd
Agena Bioscience Inc
Aldatu Biosciences Inc
Altona Diagnostic GmbH
American Biosources Inc
Applied Biological Materials Inc
Applied DNA Sciences Inc
Ares Genetics GmbH
Assurance Scientific Laboratories
Aura Biotechnologies Pvt Ltd
Avalon GloboCare Corp
Baebies Inc
Beijing Beier Bioengineering Co Ltd
Beijing Ditan Hospital
Biocore Co Ltd
Bioeksen R&D Technologies Ltd
bioMerieux SA
Bioneer Corp
BIOTECON Diagnostics GmbH
Biyani Biosolutions Pvt Ltd
BTS Consultores SAC
Caspr Biotech
Certest Biotec SL
Changzhou Biowin Pharmaceutical Co Ltd
Co-Diagnostics Inc
Columbia University Fertility Center
Cosmax Co Ltd
CrossLife Technologies Inc
CTK Biotech Inc
Daan Gene Co Ltd
DiaCarta Inc
DiaSorin Molecular LLC
DNA Xperts Pvt Ltd
Enzo Biochem Inc
Enzo Clinical Labs Inc
Escher Biomedical Diagnostics LLC
Esenso Biotech Inc
Eurobio Scientific SA
Eurofins NTD LLC
Eurofins Scientific SE
FemtoDx Inc
Fluidigm Corp
Fulgent Genetics Inc
Gencurix Co., Ltd.
GeneCast Biotechnology Co Ltd
GeneMatrix Inc
GeneMe Sp Zoo
GeneOne Diagnostics Corp
General Biologicals Corp
Genetic Signatures Ltd
GenMark Diagnostics Inc
GenomicTree Co Ltd
Genomix Biotech Inc
Genscript Biotech Corp
gerbion GmbH & Co KG
Global WholeHealth Partners Corp
Guangdong Huayin Medicine Science Co Ltd
Guangzhou Deaou Biotechnology Co Ltd
Guangzhou Weiyuan Gene Technology Co Ltd
Hangzhou Bigfish Bio-tech Co Ltd
Hangzhou Dan Wei Biotechnology Co Ltd
Healgen Scientific LLC
Higene
iCubate Inc
Illucidx Inc
Indian Institute of Science
Indian Institute of Technology Chennai
Inflammatix Inc
InGenuity Diagnostics Inc
iNtRON Biotechnology Inc
I-One Bio Co Ltd
Jn Medsys Pte Ltd
Joonghun Pharmaceutical Co Ltd
Julix (Hong Kong) Co Ltd
LabGenomics Co Ltd
Landcent Europe BV
Livzon Pharmaceutical Group Co Ltd
Long Island Biotech Inc
Luminultra Technologies Ltd
Maccura Biotech Co Ltd
Macrogen Inc
MagGenome Technologies Pvt Ltd
MAVIDx Inc
McMaster University
MedStar Medical Co Ltd
MGI Tech Co Ltd
MiCo BioMed Co Ltd
MiRXES Pte Ltd
Molecular Epidemiology Inc
MultiplexDX Sro
Mylab Discovery Solutions Pvt Ltd
NDFOS Co Ltd
NeuMoDx Molecular Inc
Ningbo Health Gene Technologies Co Ltd
Norgen Biotek Corp
Novacyt SA
Nucleome Therapeutics Ltd
Nusantics
Ohio State University
Optolane Technologies Inc
OSANG Healthcare Co Ltd
Oxford Biodynamics Plc
PathogenDx, Inc.
PaxGenBio Co Ltd
Pepex Biomedical, Inc.
PerkinElmer Inc
PharmaCyte Biotech Inc
PrimerDesign Ltd
Qiagen NV
QuantuMDx Group Ltd
RayBiotech Inc
Reagent Genie Ireland Ltd
Reliance Life Sciences Pvt Ltd
RTA Laboratories
RTA Laboratories Biological Products Pharmaceutical and Machinery Industry
Sacace Biotechnologies Srl
SD Biosensor Inc
Seegene Inc
Selfdiagnostics OU
Sentebiolab Biotechnology
Shandong Shtars Biological Industry Co Ltd
Shanghai Fosun Long March Medical Science Co Ltd
Shenzhen Second People's Hospital
Simon Fraser University
Sinsoma GmbH
Summit Biolabs Inc
TBG Diagnostics Ltd
TCM Biosciences Inc
TCM Ltd
Thermo Fisher Scientific Inc
ThermoGenesis Holdings Inc
Todos Medical
Trivitron Healthcare Pvt Ltd
University College London
University of East Anglia
University of Hong Kong
University of Rhode Island
University of Vermont
University of Washington School of Medicine
Vazyme Biotech Co Ltd
Veredus Laboratories Pte Ltd
VIC Foundry Inc
Virginia Polytechnic Institute and State University
Vivera Pharmaceuticals Inc
Wareton And Company Technology Co Ltd
West Virginia University School of Medicine
Wuhan EasyDiagnosis Biomedicine Co Ltd
Yaathum Biotech Pvt Ltd
YD Diagnostics Corporation
Zymo Research Corp

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 COVID 19 Nucleic Acid Amplification Tests (NAATs) Overview 21

3 Products under Development 22

3.1 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Stage of Development 22

3.2 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Territory 23

3.3 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Regulatory Path 25

3.4 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Estimated Approval Date 26

3.5 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Ongoing Clinical Trials 27

4 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products under Development by Companies 28

4.1 COVID 19 Nucleic Acid Amplification Tests (NAATs) Companies – Pipeline Products by Stage of Development 28

4.2 COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Stage of Development 34

5 COVID 19 Nucleic Acid Amplification Tests (NAATs) Companies and Product Overview 39

5.1 1drop Inc Company Overview 39

5.1.1 1drop Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.2 3D Medicines Inc Company Overview 40

5.2.1 3D Medicines Inc Pipeline Products & Ongoing Clinical Trials Overview 40

5.3 4basebio AG Company Overview 41

5.3.1 4basebio AG Pipeline Products & Ongoing Clinical Trials Overview 41

5.4 8 Billion Inc Company Overview 42

5.4.1 8 Billion Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.5 Aanika Biosciences Inc Company Overview 43

5.5.1 Aanika Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.6 Access Medical Labs Company Overview 44

5.6.1 Access Medical Labs Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 Acumen Research Laboratories Pte Ltd. Company Overview 45

5.7.1 Acumen Research Laboratories Pte Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45

5.8 Advanced MedTech Holdings Pte Ltd Company Overview 46

5.8.1 Advanced MedTech Holdings Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Aegea Biotechnologies Inc Company Overview 47

5.9.1 Aegea Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.10 Agappe Diagnostics Ltd Company Overview 48

5.10.1 Agappe Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.11 Agena Bioscience Inc Company Overview 49

5.11.1 Agena Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.12 Aldatu Biosciences Inc Company Overview 51

5.12.1 Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.13 Altona Diagnostic GmbH Company Overview 52

5.13.1 Altona Diagnostic GmbH Pipeline Products & Ongoing Clinical Trials Overview 52

5.14 American Biosources Inc Company Overview 53

5.14.1 American Biosources Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.15 Applied Biological Materials Inc Company Overview 54

5.15.1 Applied Biological Materials Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.16 Applied DNA Sciences Inc Company Overview 55

5.16.1 Applied DNA Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.17 Ares Genetics GmbH Company Overview 56

5.17.1 Ares Genetics GmbH Pipeline Products & Ongoing Clinical Trials Overview 56

5.18 Assurance Scientific Laboratories Company Overview 58

5.18.1 Assurance Scientific Laboratories Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 Aura Biotechnologies Pvt Ltd Company Overview 59

5.19.1 Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Avalon GloboCare Corp Company Overview 61

5.20.1 Avalon GloboCare Corp Pipeline Products & Ongoing Clinical Trials Overview 61

5.21 Baebies Inc Company Overview 62

5.21.1 Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.22 Beijing Beier Bioengineering Co Ltd Company Overview 63

5.22.1 Beijing Beier Bioengineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

5.23 Beijing Ditan Hospital Company Overview 64

5.23.1 Beijing Ditan Hospital Pipeline Products & Ongoing Clinical Trials Overview 64

5.24 Biocore Co Ltd Company Overview 67

5.24.1 Biocore Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

5.25 Bioeksen R&D Technologies Ltd Company Overview 68

5.25.1 Bioeksen R&D Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

5.26 bioMerieux SA Company Overview 69

5.26.1 bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 69

5.27 Bioneer Corp Company Overview 70

5.27.1 Bioneer Corp Pipeline Products & Ongoing Clinical Trials Overview 70

5.28 BIOTECON Diagnostics GmbH Company Overview 72

5.28.1 BIOTECON Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 72

5.29 Biyani Biosolutions Pvt Ltd Company Overview 74

5.29.1 Biyani Biosolutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

5.30 BTS Consultores SAC Company Overview 75

5.30.1 BTS Consultores SAC Pipeline Products & Ongoing Clinical Trials Overview 75

5.31 Caspr Biotech Company Overview 76

5.31.1 Caspr Biotech Pipeline Products & Ongoing Clinical Trials Overview 76

5.32 Certest Biotec SL Company Overview 77

5.32.1 Certest Biotec SL Pipeline Products & Ongoing Clinical Trials Overview 77

5.33 Changzhou Biowin Pharmaceutical Co Ltd Company Overview 78

5.33.1 Changzhou Biowin Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

5.34 Co-Diagnostics Inc Company Overview 80

5.34.1 Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.35 Columbia University Fertility Center Company Overview 84

5.35.1 Columbia University Fertility Center Pipeline Products & Ongoing Clinical Trials Overview 84

5.36 Cosmax Co Ltd Company Overview 85

5.36.1 Cosmax Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

5.37 CrossLife Technologies Inc Company Overview 86

5.37.1 CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.38 CTK Biotech Inc Company Overview 87

5.38.1 CTK Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.39 Daan Gene Co Ltd Company Overview 88

5.39.1 Daan Gene Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

5.40 DiaCarta Inc Company Overview 89

5.40.1 DiaCarta Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.41 DiaSorin Molecular LLC Company Overview 91

5.41.1 DiaSorin Molecular LLC Pipeline Products & Ongoing Clinical Trials Overview 91

5.42 DNA Xperts Pvt Ltd Company Overview 94

5.42.1 DNA Xperts Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

5.43 Enzo Biochem Inc Company Overview 96

5.43.1 Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.44 Enzo Clinical Labs Inc Company Overview 97

5.44.1 Enzo Clinical Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.45 Escher Biomedical Diagnostics LLC Company Overview 98

5.45.1 Escher Biomedical Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 98

5.46 Esenso Biotech Inc Company Overview 99

5.46.1 Esenso Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.47 Eurobio Scientific SA Company Overview 100

5.47.1 Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 100

5.48 Eurofins NTD LLC Company Overview 101

5.48.1 Eurofins NTD LLC Pipeline Products & Ongoing Clinical Trials Overview 101

5.49 Eurofins Scientific SE Company Overview 103

5.49.1 Eurofins Scientific SE Pipeline Products & Ongoing Clinical Trials Overview 103

5.50 FemtoDx Inc Company Overview 105

5.50.1 FemtoDx Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.51 Fluidigm Corp Company Overview 106

5.51.1 Fluidigm Corp Pipeline Products & Ongoing Clinical Trials Overview 106

5.52 Fulgent Genetics Inc Company Overview 108

5.52.1 Fulgent Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

5.53 Gencurix Co., Ltd. Company Overview 109

5.53.1 Gencurix Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 109

5.54 GeneCast Biotechnology Co Ltd Company Overview 110

5.54.1 GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

5.55 GeneMatrix Inc Company Overview 111

5.55.1 GeneMatrix Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.56 GeneMe Sp Zoo Company Overview 112

5.56.1 GeneMe Sp Zoo Pipeline Products & Ongoing Clinical Trials Overview 112

5.57 GeneOne Diagnostics Corp Company Overview 113

5.57.1 GeneOne Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 113

5.58 General Biologicals Corp Company Overview 114

5.58.1 General Biologicals Corp Pipeline Products & Ongoing Clinical Trials Overview 114

5.59 Genetic Signatures Ltd Company Overview 115

5.59.1 Genetic Signatures Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

5.60 GenMark Diagnostics Inc Company Overview 116

5.60.1 GenMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 116

5.61 GenomicTree Co Ltd Company Overview 117

5.61.1 GenomicTree Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.62 Genomix Biotech Inc Company Overview 118

5.62.1 Genomix Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 118

5.63 Genscript Biotech Corp Company Overview 119

5.63.1 Genscript Biotech Corp Pipeline Products & Ongoing Clinical Trials Overview 119

5.64 gerbion GmbH & Co KG Company Overview 120

5.64.1 gerbion GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 120

5.65 Global WholeHealth Partners Corp Company Overview 121

5.65.1 Global WholeHealth Partners Corp Pipeline Products & Ongoing Clinical Trials Overview 121

5.66 Guangdong Huayin Medicine Science Co Ltd Company Overview 122

5.66.1 Guangdong Huayin Medicine Science Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

5.67 Guangzhou Deaou Biotechnology Co Ltd Company Overview 123

5.67.1 Guangzhou Deaou Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

5.68 Guangzhou Weiyuan Gene Technology Co Ltd Company Overview 124

5.68.1 Guangzhou Weiyuan Gene Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

5.69 Hangzhou Bigfish Bio-tech Co Ltd Company Overview 125

5.69.1 Hangzhou Bigfish Bio-tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

5.70 Hangzhou Dan Wei Biotechnology Co Ltd Company Overview 127

5.70.1 Hangzhou Dan Wei Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

5.71 Healgen Scientific LLC Company Overview 128

5.71.1 Healgen Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 128

5.72 Higene Company Overview 129

5.72.1 Higene Pipeline Products & Ongoing Clinical Trials Overview 129

5.73 iCubate Inc Company Overview 130

5.73.1 iCubate Inc Pipeline Products & Ongoing Clinical Trials Overview 130

5.74 Illucidx Inc Company Overview 131

5.74.1 Illucidx Inc Pipeline Products & Ongoing Clinical Trials Overview 131

5.75 Indian Institute of Science Company Overview 132

5.75.1 Indian Institute of Science Pipeline Products & Ongoing Clinical Trials Overview 132

5.76 Indian Institute of Technology Chennai Company Overview 133

5.76.1 Indian Institute of Technology Chennai Pipeline Products & Ongoing Clinical Trials Overview 133

5.77 Inflammatix Inc Company Overview 134

5.77.1 Inflammatix Inc Pipeline Products & Ongoing Clinical Trials Overview 134

5.78 InGenuity Diagnostics Inc Company Overview 135

5.78.1 InGenuity Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.79 iNtRON Biotechnology Inc Company Overview 136

5.79.1 iNtRON Biotechnology Inc Pipeline Products & Ongoing Clinical Trials Overview 136

5.80 I-One Bio Co Ltd Company Overview 137

5.80.1 I-One Bio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

5.81 Jn Medsys Pte Ltd Company Overview 138

5.81.1 Jn Medsys Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

5.82 Joonghun Pharmaceutical Co Ltd Company Overview 139

5.82.1 Joonghun Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 139

5.83 Julix (Hong Kong) Co Ltd Company Overview 140

5.83.1 Julix (Hong Kong) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

5.84 LabGenomics Co Ltd Company Overview 141

5.84.1 LabGenomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

5.85 Landcent Europe BV Company Overview 142

5.85.1 Landcent Europe BV Pipeline Products & Ongoing Clinical Trials Overview 142

5.86 Livzon Pharmaceutical Group Co Ltd Company Overview 143

5.86.1 Livzon Pharmaceutical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

5.87 Long Island Biotech Inc Company Overview 144

5.87.1 Long Island Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 144

5.88 Luminultra Technologies Ltd Company Overview 145

5.88.1 Luminultra Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 145

5.89 Maccura Biotech Co Ltd Company Overview 146

5.89.1 Maccura Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

5.90 Macrogen Inc Company Overview 147

5.90.1 Macrogen Inc Pipeline Products & Ongoing Clinical Trials Overview 147

5.91 MagGenome Technologies Pvt Ltd Company Overview 148

5.91.1 MagGenome Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

5.92 MAVIDx Inc Company Overview 149

5.92.1 MAVIDx Inc Pipeline Products & Ongoing Clinical Trials Overview 149

5.93 McMaster University Company Overview 150

5.93.1 McMaster University Pipeline Products & Ongoing Clinical Trials Overview 150

5.94 MedStar Medical Co Ltd Company Overview 151

5.94.1 MedStar Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

5.95 MGI Tech Co Ltd Company Overview 152

5.95.1 MGI Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 152

5.96 MiCo BioMed Co Ltd Company Overview 153

5.96.1 MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

5.97 MiRXES Pte Ltd Company Overview 154

5.97.1 MiRXES Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

5.98 Molecular Epidemiology Inc Company Overview 155

5.98.1 Molecular Epidemiology Inc Pipeline Products & Ongoing Clinical Trials Overview 155

5.99 MultiplexDX Sro Company Overview 156

5.99.1 MultiplexDX Sro Pipeline Products & Ongoing Clinical Trials Overview 156

5.100 Mylab Discovery Solutions Pvt Ltd Company Overview 157

5.100.1 Mylab Discovery Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

5.101 NDFOS Co Ltd Company Overview 158

5.101.1 NDFOS Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

5.102 NeuMoDx Molecular Inc Company Overview 159

5.102.1 NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 159

5.103 Ningbo Health Gene Technologies Co Ltd Company Overview 160

5.103.1 Ningbo Health Gene Technologies Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

5.104 Norgen Biotek Corp Company Overview 161

5.104.1 Norgen Biotek Corp Pipeline Products & Ongoing Clinical Trials Overview 161

5.105 Novacyt SA Company Overview 162

5.105.1 Novacyt SA Pipeline Products & Ongoing Clinical Trials Overview 162

5.106 Nucleome Therapeutics Ltd Company Overview 164

5.106.1 Nucleome Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 164

5.107 Nusantics Company Overview 165

5.107.1 Nusantics Pipeline Products & Ongoing Clinical Trials Overview 165

5.108 Ohio State University Company Overview 166

5.108.1 Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 166

5.109 Optolane Technologies Inc Company Overview 167

5.109.1 Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 167

5.110 OSANG Healthcare Co Ltd Company Overview 168

5.110.1 OSANG Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

5.111 Oxford Biodynamics Plc Company Overview 169

5.111.1 Oxford Biodynamics Plc Pipeline Products & Ongoing Clinical Trials Overview 169

5.112 PathogenDx, Inc. Company Overview 170

5.112.1 PathogenDx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

5.113 PaxGenBio Co Ltd Company Overview 172

5.113.1 PaxGenBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

5.114 Pepex Biomedical, Inc. Company Overview 173

5.114.1 Pepex Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173

5.115 PerkinElmer Inc Company Overview 174

5.115.1 PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 174

5.116 PharmaCyte Biotech Inc Company Overview 175

5.116.1 PharmaCyte Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 175

5.117 PrimerDesign Ltd Company Overview 176

5.117.1 PrimerDesign Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

5.118 Qiagen NV Company Overview 177

5.118.1 Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 177

5.119 QuantuMDx Group Ltd Company Overview 179

5.119.1 QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 179

5.120 RayBiotech Inc Company Overview 181

5.120.1 RayBiotech Inc Pipeline Products & Ongoing Clinical Trials Overview 181

5.121 Reagent Genie Ireland Ltd Company Overview 182

5.121.1 Reagent Genie Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 182

5.122 Reliance Life Sciences Pvt Ltd Company Overview 183

5.122.1 Reliance Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 183

5.123 RTA Laboratories Company Overview 184

5.123.1 RTA Laboratories Pipeline Products & Ongoing Clinical Trials Overview 184

5.124 RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Company Overview 185

5.124.1 RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Pipeline Products & Ongoing Clinical Trials Overview 185

5.125 Sacace Biotechnologies Srl Company Overview 186

5.125.1 Sacace Biotechnologies Srl Pipeline Products & Ongoing Clinical Trials Overview 186

5.126 SD Biosensor Inc Company Overview 187

5.126.1 SD Biosensor Inc Pipeline Products & Ongoing Clinical Trials Overview 187

5.127 Seegene Inc Company Overview 188

5.127.1 Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 188

5.128 Selfdiagnostics OU Company Overview 189

5.128.1 Selfdiagnostics OU Pipeline Products & Ongoing Clinical Trials Overview 189

5.129 Sentebiolab Biotechnology Company Overview 190

5.129.1 Sentebiolab Biotechnology Pipeline Products & Ongoing Clinical Trials Overview 190

5.130 Shandong Shtars Biological Industry Co Ltd Company Overview 191

5.130.1 Shandong Shtars Biological Industry Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

5.131 Shanghai Fosun Long March Medical Science Co Ltd Company Overview 192

5.131.1 Shanghai Fosun Long March Medical Science Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 192

5.132 Shenzhen Second People’s Hospital Company Overview 193

5.132.1 Shenzhen Second People’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 193

5.133 Simon Fraser University Company Overview 196

5.133.1 Simon Fraser University Pipeline Products & Ongoing Clinical Trials Overview 196

5.134 Sinsoma GmbH Company Overview 197

5.134.1 Sinsoma GmbH Pipeline Products & Ongoing Clinical Trials Overview 197

5.135 Summit Biolabs Inc Company Overview 198

5.135.1 Summit Biolabs Inc Pipeline Products & Ongoing Clinical Trials Overview 198

5.136 TBG Diagnostics Ltd Company Overview 199

5.136.1 TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 199

5.137 TCM Biosciences Inc Company Overview 200

5.137.1 TCM Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 200

5.138 TCM Ltd Company Overview 201

5.138.1 TCM Ltd Pipeline Products & Ongoing Clinical Trials Overview 201

5.139 Thermo Fisher Scientific Inc Company Overview 202

5.139.1 Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 202

5.140 ThermoGenesis Holdings Inc Company Overview 204

5.140.1 ThermoGenesis Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 204

5.141 Todos Medical Company Overview 205

5.141.1 Todos Medical Pipeline Products & Ongoing Clinical Trials Overview 205

5.142 Trivitron Healthcare Pvt Ltd Company Overview 206

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

5.143 University College London Company Overview 207

5.143.1 University College London Pipeline Products & Ongoing Clinical Trials Overview 207

5.144 University of East Anglia Company Overview 210

5.144.1 University of East Anglia Pipeline Products & Ongoing Clinical Trials Overview 210

5.145 University of Hong Kong Company Overview 211

5.145.1 University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 211

5.146 University of Rhode Island Company Overview 212

5.146.1 University of Rhode Island Pipeline Products & Ongoing Clinical Trials Overview 212

5.147 University of Vermont Company Overview 213

5.147.1 University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 213

5.148 University of Washington School of Medicine Company Overview 214

5.148.1 University of Washington School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 214

5.149 Vazyme Biotech Co Ltd Company Overview 215

5.149.1 Vazyme Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

5.150 Veredus Laboratories Pte Ltd Company Overview 216

5.150.1 Veredus Laboratories Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

5.151 VIC Foundry Inc Company Overview 217

5.151.1 VIC Foundry Inc Pipeline Products & Ongoing Clinical Trials Overview 217

5.152 Virginia Polytechnic Institute and State University Company Overview 218

5.152.1 Virginia Polytechnic Institute and State University Pipeline Products & Ongoing Clinical Trials Overview 218

5.153 Vivera Pharmaceuticals Inc Company Overview 219

5.153.1 Vivera Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 219

5.154 Wareton And Company Technology Co Ltd Company Overview 222

5.154.1 Wareton And Company Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 222

5.155 West Virginia University School of Medicine Company Overview 223

5.155.1 West Virginia University School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 223

5.156 Wuhan EasyDiagnosis Biomedicine Co Ltd Company Overview 224

5.156.1 Wuhan EasyDiagnosis Biomedicine Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

5.157 Yaathum Biotech Pvt Ltd Company Overview 225

5.157.1 Yaathum Biotech Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 225

5.158 YD Diagnostics Corporation Company Overview 226

5.158.1 YD Diagnostics Corporation Pipeline Products & Ongoing Clinical Trials Overview 226

5.159 Zymo Research Corp Company Overview 227

5.159.1 Zymo Research Corp Pipeline Products & Ongoing Clinical Trials Overview 227

6 COVID 19 Nucleic Acid Amplification Tests (NAATs)- Recent Developments 228

6.1 Nov 15, 2021: Applied DNA subsidiary LineaRx receives repeat orders for LinearDNA, adds federally funded cancer research laboratory as CRO customer 228

6.2 Nov 09, 2021: Research publication demonstrates utility of Applied DNA’s LinearDNA in non-viral CAR T manufacturing systems 228

6.3 May 19, 2021: FDA grants EUA to Roche’s Covid-19 test for asymptomatic people 229

7 Appendix 231

7.1 Methodology 231

7.2 About GlobalData 234

7.3 Contact Us 234

List of Tables

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Stage of Development 22

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Territory 23

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Regulatory Path 25

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Estimated Approval Date 26

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Ongoing Clinical Trials 27

COVID 19 Nucleic Acid Amplification Tests (NAATs) Companies – Pipeline Products by Stage of Development 28

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Stage of Development 34

1drop Inc Pipeline Products & Ongoing Clinical Trials Overview 39

1Copy COVID-19 QPCR 4Plex Kit – Product Status 39

1Copy COVID-19 QPCR 4Plex Kit – Product Description 39

3D Medicines Inc Pipeline Products & Ongoing Clinical Trials Overview 40

ANDiS SARS-CoV-2 RT-qPCR Detection Kit – Product Status 40

ANDiS SARS-CoV-2 RT-qPCR Detection Kit – Product Description 40

4basebio AG Pipeline Products & Ongoing Clinical Trials Overview 41

SARS-CoV-2 Detection System – Product Status 41

SARS-CoV-2 Detection System – Product Description 41

8 Billion Inc Pipeline Products & Ongoing Clinical Trials Overview 42

U-top COVID-19 Detection Kit – Product Status 42

U-top COVID-19 Detection Kit – Product Description 42

Aanika Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 43

LAMP Diagnostic Test – SARS-CoV-2 – Product Status 43

LAMP Diagnostic Test – SARS-CoV-2 – Product Description 43

Access Medical Labs Pipeline Products & Ongoing Clinical Trials Overview 44

RT-PCR Test – COVID-19 – Product Status 44

RT-PCR Test – COVID-19 – Product Description 44

Acumen Research Laboratories Pte Ltd. Pipeline Products & Ongoing Clinical Trials Overview 45

Acu-Corona 2.0 – Product Status 45

Acu-Corona 2.0 – Product Description 45

Advanced MedTech Holdings Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Resolute 2.0 Assay – Product Status 46

Resolute 2.0 Assay – Product Description 46

Aegea Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 47

COVID-19 PCR Assay – Product Status 47

COVID-19 PCR Assay – Product Description 47

Agappe Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

Chitra GeneLAMP-N – Product Status 48

Chitra GeneLAMP-N – Product Description 48

Agena Bioscience Inc Pipeline Products & Ongoing Clinical Trials Overview 49

iPLEX Pro SARS-CoV-2 Panel – Product Status 49

iPLEX Pro SARS-CoV-2 Panel – Product Description 49

MassARRAY SARS-CoV-2 Panel – Product Status 50

MassARRAY SARS-CoV-2 Panel – Product Description 50

Aldatu Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 51

PANDAA qDx SARS-CoV-2 Kit – Product Status 51

PANDAA qDx SARS-CoV-2 Kit – Product Description 51

Altona Diagnostic GmbH Pipeline Products & Ongoing Clinical Trials Overview 52

Lollipop PCR Test – SARS-CoV-2 – Product Status 52

Lollipop PCR Test – SARS-CoV-2 – Product Description 52

American Biosources Inc Pipeline Products & Ongoing Clinical Trials Overview 53

GDx GrandPerformance SARS-CoV-2 Detection Kit – Product Status 53

GDx GrandPerformance SARS-CoV-2 Detection Kit – Product Description 53

Applied Biological Materials Inc Pipeline Products & Ongoing Clinical Trials Overview 54

GenomeCoV19 Detection Kit – Product Status 54

GenomeCoV19 Detection Kit – Product Description 54

Applied DNA Sciences Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Linea SARS-CoV-2 Mutation Panel – Product Status 55

Linea SARS-CoV-2 Mutation Panel – Product Description 55

Ares Genetics GmbH Pipeline Products & Ongoing Clinical Trials Overview 56

NGS Test – 2019-nCoV – Product Status 56

NGS Test – 2019-nCoV – Product Description 56

RT PCR Test – 2019-nCoV – Product Status 57

RT PCR Test – 2019-nCoV – Product Description 57

Assurance Scientific Laboratories Pipeline Products & Ongoing Clinical Trials Overview 58

PCR Test – COVID-19 UK Variant – Product Status 58

PCR Test – COVID-19 UK Variant – Product Description 58

Aura Biotechnologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

Quick COVID-19 Colorimetric LAMP PCR – Product Status 59

Quick COVID-19 Colorimetric LAMP PCR – Product Description 59

Quick COVID-19 Realtime Multiplex PCR – Product Status 60

Quick COVID-19 Realtime Multiplex PCR – Product Description 60

Avalon GloboCare Corp Pipeline Products & Ongoing Clinical Trials Overview 61

PCR-Based SARS-CoV-2 Detection System – Product Status 61

PCR-Based SARS-CoV-2 Detection System – Product Description 61

Baebies Inc Pipeline Products & Ongoing Clinical Trials Overview 62

FINDER SARS-CoV-2 Test – Product Status 62

FINDER SARS-CoV-2 Test – Product Description 62

Beijing Beier Bioengineering Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 63

Multiple Real-Time PCR Kit – SARS-CoV-2 – Product Status 63

Multiple Real-Time PCR Kit – SARS-CoV-2 – Product Description 63

Beijing Ditan Hospital Pipeline Products & Ongoing Clinical Trials Overview 64

RT-RAA Diagnostic Assay – 2019-nCoV – Product Status 64

RT-RAA Diagnostic Assay – 2019-nCoV – Product Description 64

Beijing Ditan Hospital – Ongoing Clinical Trials Overview 65

RT-RAA Diagnostic Assay – 2019-nCoV – Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV 66

Biocore Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 67

BioCore 2019-nCoV Real Time PCR Kit – Product Status 67

BioCore 2019-nCoV Real Time PCR Kit – Product Description 67

Bioeksen R&D Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

Bio-Speedy Direct RT-qPCR SARS-CoV-2 – Product Status 68

Bio-Speedy Direct RT-qPCR SARS-CoV-2 – Product Description 68

bioMerieux SA Pipeline Products & Ongoing Clinical Trials Overview 69

Argene Sars-Cov-2 R-Gene Test – Product Status 69

Argene Sars-Cov-2 R-Gene Test – Product Description 69

Bioneer Corp Pipeline Products & Ongoing Clinical Trials Overview 70

AccuPower COVID-19 Real-Time RT-PCR Kit – Product Status 70

AccuPower COVID-19 Real-Time RT-PCR Kit – Product Description 70

Diagnostic Test – COVID-19 – Product Status 71

Diagnostic Test – COVID-19 – Product Description 71

BIOTECON Diagnostics GmbH Pipeline Products & Ongoing Clinical Trials Overview 72

microproof SARS-CoV-2 Identification Kit – Product Status 72

microproof SARS-CoV-2 Identification Kit – Product Description 72

microproof SARS-CoV-2 Screening Kit – Product Status 73

microproof SARS-CoV-2 Screening Kit – Product Description 73

Biyani Biosolutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

Self-Swab RNA Test – COVID-19 – Product Status 74

Self-Swab RNA Test – COVID-19 – Product Description 74

BTS Consultores SAC Pipeline Products & Ongoing Clinical Trials Overview 75

CavBio RT-PCR COVID-19 Kit V1.0 – Product Status 75

CavBio RT-PCR COVID-19 Kit V1.0 – Product Description 75

Caspr Biotech Pipeline Products & Ongoing Clinical Trials Overview 76

Direct Caspr Lyo-CRISPR SARS-CoV-2 – Product Status 76

Direct Caspr Lyo-CRISPR SARS-CoV-2 – Product Description 76

Certest Biotec SL Pipeline Products & Ongoing Clinical Trials Overview 77

VIASURE SARS-CoV-2 Real Time PCR Detection Kit – Product Status 77

VIASURE SARS-CoV-2 Real Time PCR Detection Kit – Product Description 77

Changzhou Biowin Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (fluorescence RT-PCR) – Product Status 78

Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (fluorescence RT-PCR) – Product Description 78

Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (RT-LAMP) – Product Status 79

Novel Coronavirus (COVID-19) Nucleic Acid Test Kit (RT-LAMP) – Product Description 79

Co-Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 80

EIKON PCR – Product Status 80

EIKON PCR – Product Description 81

Logix Smart COVID-19 Test – Product Status 81

Logix Smart COVID-19 Test – Product Description 81

Logix Smart SARS-CoV-2 (genes RdRp/E) Test Kit – Product Status 82

Logix Smart SARS-CoV-2 (genes RdRp/E) Test Kit – Product Description 82

Logix Smart SARS-CoV-2 DS Test Kit – Product Status 82

Logix Smart SARS-CoV-2 DS Test Kit – Product Description 83

Columbia University Fertility Center Pipeline Products & Ongoing Clinical Trials Overview 84

COVID-19 Saliva Test – Product Status 84

COVID-19 Saliva Test – Product Description 84

Cosmax Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 85

iDetect SARS-CoV-2 Detection Kit – Product Status 85

iDetect SARS-CoV-2 Detection Kit – Product Description 85

CrossLife Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 86

CLT SARS-CoV-2 qRT-PCR Assay – Product Status 86

CLT SARS-CoV-2 qRT-PCR Assay – Product Description 86

CTK Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Aridia COVID-19 Real Time PCR Test – Product Status 87

Aridia COVID-19 Real Time PCR Test – Product Description 87

Daan Gene Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 88

Detection Kit (2019-nCoV) RNA (PCR-Fluorescence Probing) – Product Status 88

Detection Kit (2019-nCoV) RNA (PCR-Fluorescence Probing) – Product Description 88

DiaCarta Inc Pipeline Products & Ongoing Clinical Trials Overview 89

QuantiVirus SARS-CoV-2 Multiplex Test Kit – Product Status 89

QuantiVirus SARS-CoV-2 Multiplex Test Kit – Product Description 89

Rapid SARS-Cov-2 Variant Detection Test – Product Status 90

Rapid SARS-Cov-2 Variant Detection Test – Product Description 90

DiaSorin Molecular LLC Pipeline Products & Ongoing Clinical Trials Overview 91

Simplexa COVID-19 Direct Assay – Product Status 91

Simplexa COVID-19 Direct Assay – Product Description 91

DiaSorin Molecular LLC – Ongoing Clinical Trials Overview 92

Simplexa COVID-19 Direct Assay – Diagnostic Performance of the ID Now COVID-19 Screening Test Versus Simplexa COVID-19 Direct Assay in Off-site Biology in Emergency Rooms for COVID-19 Screening 93

DNA Xperts Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 94

COVID-19 RT-PCR Kit – V1 – Product Status 94

COVID-19 RT-PCR Kit – V1 – Product Description 94

COVID-19 RT-PCR Kit – V2 – Product Status 94

COVID-19 RT-PCR Kit – V2 – Product Description 95

Enzo Biochem Inc Pipeline Products & Ongoing Clinical Trials Overview 96

Molecular Ampiprobe SARS-CoV-2 Test – Product Status 96

Molecular Ampiprobe SARS-CoV-2 Test – Product Description 96

Enzo Clinical Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 97

Next Generation – COVID-19 Test – Product Status 97

Next Generation – COVID-19 Test – Product Description 97

Escher Biomedical Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 98

BT-MED COV19 Test – Product Status 98

BT-MED COV19 Test – Product Description 98

Esenso Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 99

COVID-19 Nucleic Acid Detection Kit – Product Status 99

COVID-19 Nucleic Acid Detection Kit – Product Description 99

Eurobio Scientific SA Pipeline Products & Ongoing Clinical Trials Overview 100

EBX-044 – Product Status 100

EBX-044 – Product Description 100

Eurofins NTD LLC Pipeline Products & Ongoing Clinical Trials Overview 101

GSD NovaPrime RNA Extraction AE1 Kit – Product Status 101

GSD NovaPrime RNA Extraction AE1 Kit – Product Description 101

GSD NovaPrime RNA Extraction AE2 Kit – Product Status 102

GSD NovaPrime RNA Extraction AE2 Kit – Product Description 102

Eurofins Scientific SE Pipeline Products & Ongoing Clinical Trials Overview 103

GSD NovaPrime SARS-CoV-2 (COVID-19) RT-PCR Kit – Product Status 103

GSD NovaPrime SARS-CoV-2 (COVID-19) RT-PCR Kit – Product Description 103

GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) Kit – Product Status 104

GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) Kit – Product Description 104

FemtoDx Inc Pipeline Products & Ongoing Clinical Trials Overview 105

COVID-19 Rapid Home Nucleic Acid Test – Product Status 105

COVID-19 Rapid Home Nucleic Acid Test – Product Description 105

Fluidigm Corp Pipeline Products & Ongoing Clinical Trials Overview 106

Advanta Dx SARS-CoV-2 RT-PCR Test – Product Status 106

Advanta Dx SARS-CoV-2 RT-PCR Test – Product Description 107

Fulgent Genetics Inc Pipeline Products & Ongoing Clinical Trials Overview 108

Kiloplex PCR Plus NGS – COVID-19 – Product Status 108

Kiloplex PCR Plus NGS – COVID-19 – Product Description 108

Gencurix Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 109

GenePro COVID19 Detection Test – Product Status 109

GenePro COVID19 Detection Test – Product Description 109

GeneCast Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 110

GCare SARS-coV-2 – Product Status 110

GCare SARS-coV-2 – Product Description 110

GeneMatrix Inc Pipeline Products & Ongoing Clinical Trials Overview 111

NeoPlex COVID-19 Detection Kit – Product Status 111

NeoPlex COVID-19 Detection Kit – Product Description 111

GeneMe Sp Zoo Pipeline Products & Ongoing Clinical Trials Overview 112

FRANKD Test – Product Status 112

FRANKD Test – Product Description 112

GeneOne Diagnostics Corp Pipeline Products & Ongoing Clinical Trials Overview 113

COVID-19 Nucleic Acid Diagnostic Kit – Product Status 113

COVID-19 Nucleic Acid Diagnostic Kit – Product Description 113

General Biologicals Corp Pipeline Products & Ongoing Clinical Trials Overview 114

GB SARS-CoV-2 Real Time RT-PCR – Product Status 114

GB SARS-CoV-2 Real Time RT-PCR – Product Description 114

Genetic Signatures Ltd Pipeline Products & Ongoing Clinical Trials Overview 115

EasyScreen SARS-CoV-2 Detection Kit – Product Status 115

EasyScreen SARS-CoV-2 Detection Kit – Product Description 115

GenMark Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 116

eSensor SARS-CoV-2 Test – Product Status 116

eSensor SARS-CoV-2 Test – Product Description 116

GenomicTree Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

AccuraDTect SARS-CoV-2 RT-qPCR Kit – Product Status 117

AccuraDTect SARS-CoV-2 RT-qPCR Kit – Product Description 117

Genomix Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 118

RT-PCR Kit – COVID-19 – Product Status 118

RT-PCR Kit – COVID-19 – Product Description 118

Genscript Biotech Corp Pipeline Products & Ongoing Clinical Trials Overview 119

qRT-PCR Detection Assay – Wuhan Novel Coronavirus (2019-nCoV) – Product Status 119

qRT-PCR Detection Assay – Wuhan Novel Coronavirus (2019-nCoV) – Product Description 119

gerbion GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 120

virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 – Product Status 120

virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 – Product Description 120

Global WholeHealth Partners Corp Pipeline Products & Ongoing Clinical Trials Overview 121

RT-qPCR Test – COVID-19 – Product Status 121

RT-qPCR Test – COVID-19 – Product Description 121

Guangdong Huayin Medicine Science Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

Detection Kit – 2019-nCoV RNA – Product Status 122

Detection Kit – 2019-nCoV RNA – Product Description 122

Guangzhou Deaou Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 123

COVID-2019 Virus Nucleic Acid Detection Kit (Dual-RT-PCR) – Product Status 123

COVID-2019 Virus Nucleic Acid Detection Kit (Dual-RT-PCR) – Product Description 123

Guangzhou Weiyuan Gene Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 124

Coronavirus Nucleic Acid Detection Kit – Product Status 124

Coronavirus Nucleic Acid Detection Kit – Product Description 124

Hangzhou Bigfish Bio-tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 125

LAMP Kit – SARS-CoV-2 – Product Status 125

LAMP Kit – SARS-CoV-2 – Product Description 125

Nucleic Acid Detection Test – SARS-COV-2 – Product Status 125

Nucleic Acid Detection Test – SARS-COV-2 – Product Description 126

Hangzhou Dan Wei Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 127

2019-nCoV Direct RT-qPCR Kit – Product Status 127

2019-nCoV Direct RT-qPCR Kit – Product Description 127

Healgen Scientific LLC Pipeline Products & Ongoing Clinical Trials Overview 128

2019-NCOV Direct QPCR Kit – Product Status 128

2019-NCOV Direct QPCR Kit – Product Description 128

Higene Pipeline Products & Ongoing Clinical Trials Overview 129

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit – Product Status 129

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit – Product Description 129

iCubate Inc Pipeline Products & Ongoing Clinical Trials Overview 130

iC-COVID19 Assay – Product Status 130

iC-COVID19 Assay – Product Description 130

Illucidx Inc Pipeline Products & Ongoing Clinical Trials Overview 131

Illucidx COVID-19 Dx RT-LAMP – Product Status 131

Illucidx COVID-19 Dx RT-LAMP – Product Description 131

Indian Institute of Science Pipeline Products & Ongoing Clinical Trials Overview 132

Diagnostic Test Kit – COVID-19 – Product Status 132

Diagnostic Test Kit – COVID-19 – Product Description 132

Indian Institute of Technology Chennai Pipeline Products & Ongoing Clinical Trials Overview 133

RT-PCR Diagnostic Kit – COVID-19 – Product Status 133

RT-PCR Diagnostic Kit – COVID-19 – Product Description 133

Inflammatix Inc Pipeline Products & Ongoing Clinical Trials Overview 134

CoVerity COVID-19 Severity Test – Product Status 134

CoVerity COVID-19 Severity Test – Product Description 134

InGenuity Diagnostics Inc Pipeline Products & Ongoing Clinical Trials Overview 135

RT-PCR Direct With VTM – Product Status 135

RT-PCR Direct With VTM – Product Description 135

iNtRON Biotechnology Inc Pipeline Products & Ongoing Clinical Trials Overview 136

LiliF COVID-19 Real-time RT-PCR Kit – Product Status 136

LiliF COVID-19 Real-time RT-PCR Kit – Product Description 136

I-One Bio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 137

Ilamp Novel-Cov19 Detection Kit – Product Status 137

Ilamp Novel-Cov19 Detection Kit – Product Description 137

Jn Medsys Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 138

ProTect COVID-19 RT-qPCR Kit – Product Status 138

ProTect COVID-19 RT-qPCR Kit – Product Description 138

Joonghun Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 139

JD COVID-19 qRT-PCR Kit – Product Status 139

JD COVID-19 qRT-PCR Kit – Product Description 139

Julix (Hong Kong) Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 140

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit – Product Status 140

Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit – Product Description 140

LabGenomics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 141

LabGun COVID-19 RT-PCR Kit – Product Status 141

LabGun COVID-19 RT-PCR Kit – Product Description 141

Landcent Europe BV Pipeline Products & Ongoing Clinical Trials Overview 142

Real Time RT-PCR Kit – SARS-CoV-2 – Product Status 142

Real Time RT-PCR Kit – SARS-CoV-2 – Product Description 142

Livzon Pharmaceutical Group Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 143

Nucleic Acid Diagnostic Kit – COVID-19 – Product Status 143

Nucleic Acid Diagnostic Kit – COVID-19 – Product Description 143

Long Island Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 144

Novel Coronavirus (2019-nCoV) Real-Time PCR Kit – Product Status 144

Novel Coronavirus (2019-nCoV) Real-Time PCR Kit – Product Description 144

Luminultra Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 145

GeneCount COVID-19 RT-qPCR Assay Kit – Product Status 145

GeneCount COVID-19 RT-qPCR Assay Kit – Product Description 145

Maccura Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 146

SARS-CoV-2 Fluorescent PCR Kit – Product Status 146

SARS-CoV-2 Fluorescent PCR Kit – Product Description 146

Macrogen Inc Pipeline Products & Ongoing Clinical Trials Overview 147

Axen COVID-19 RT – Product Status 147

Axen COVID-19 RT – Product Description 147

MagGenome Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 148

Diagnostic Test – COVID-19 – Product Status 148

Diagnostic Test – COVID-19 – Product Description 148

MAVIDx Inc Pipeline Products & Ongoing Clinical Trials Overview 149

Genomic Test – SARS-CoV-2 – Product Status 149

Genomic Test – SARS-CoV-2 – Product Description 149

McMaster University Pipeline Products & Ongoing Clinical Trials Overview 150

Self-Diagnosis Kit – COVID-19 – Product Status 150

Self-Diagnosis Kit – COVID-19 – Product Description 150

MedStar Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 151

One-Step Direct Real Time PCR Test Kit – COVID-19 – Product Status 151

One-Step Direct Real Time PCR Test Kit – COVID-19 – Product Description 151

MGI Tech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 152

Fast SARS-CoV-2 NAT – Product Status 152

Fast SARS-CoV-2 NAT – Product Description 152

MiCo BioMed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 153

Veri-Q COVID-19 Multiplex Detection Kit – Product Status 153

Veri-Q COVID-19 Multiplex Detection Kit – Product Description 153

MiRXES Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 154

Fortitude Kit 3.0 COVID-19 RT-PCR Test – Product Status 154

Fortitude Kit 3.0 COVID-19 RT-PCR Test – Product Description 154

Molecular Epidemiology Inc Pipeline Products & Ongoing Clinical Trials Overview 155

IEH SARS-CoV-2 RT-PCR Test – Product Status 155

IEH SARS-CoV-2 RT-PCR Test – Product Description 155

MultiplexDX Sro Pipeline Products & Ongoing Clinical Trials Overview 156

rTEST COVID-19 qPCR MULTIPLEX – Product Status 156

rTEST COVID-19 qPCR MULTIPLEX – Product Description 156

Mylab Discovery Solutions Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

Mylab PathoDetect COVID-19 Qualitative PCR kit – Product Status 157

Mylab PathoDetect COVID-19 Qualitative PCR kit – Product Description 157

NDFOS Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

ND COVID-19 Detection Kit – Product Status 158

ND COVID-19 Detection Kit – Product Description 158

NeuMoDx Molecular Inc Pipeline Products & Ongoing Clinical Trials Overview 159

NeuMoDx SARS-CoV-2 Assay – Product Status 159

NeuMoDx SARS-CoV-2 Assay – Product Description 159

Ningbo Health Gene Technologies Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 160

SARS-CoV-2 Virus Detection Diagnostic Kit – Product Status 160

SARS-CoV-2 Virus Detection Diagnostic Kit – Product Description 160

Norgen Biotek Corp Pipeline Products & Ongoing Clinical Trials Overview 161

COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx – Product Status 161

COVID-19 TaqMan RT-PCR Kit (E/RdRP genes) Dx – Product Description 161

Novacyt SA Pipeline Products & Ongoing Clinical Trials Overview 162

LAMP COVID-19 Test – Product Status 162

LAMP COVID-19 Test – Product Description 162

PROmate SARS-CoV-2 E484K Test – Product Status 163

PROmate SARS-CoV-2 E484K Test – Product Description 163

Nucleome Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 164

DNA Sequencing-Based Assay – Product Status 164

DNA Sequencing-Based Assay – Product Description 164

Nusantics Pipeline Products & Ongoing Clinical Trials Overview 165

Test Kit – COVID-19 – Product Status 165

Test Kit – COVID-19 – Product Description 165

Ohio State University Pipeline Products & Ongoing Clinical Trials Overview 166

SARS-CoV-2 Diagnostic Assay – Product Status 166

SARS-CoV-2 Diagnostic Assay – Product Description 166

Optolane Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 167

Kaira 2019-nCoV Detection Kit – Product Status 167

Kaira 2019-nCoV Detection Kit – Product Description 167

OSANG Healthcare Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 168

Genefinder COVID-19 Fast Realamp Kit – Product Status 168

Genefinder COVID-19 Fast Realamp Kit – Product Description 168

Oxford Biodynamics Plc Pipeline Products & Ongoing Clinical Trials Overview 169

EpiSwitch COVID-19 Disease Severity Test – Product Status 169

EpiSwitch COVID-19 Disease Severity Test – Product Description 169

PathogenDx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

DetectX-Rv – Product Status 170

DetectX-Rv – Product Description 170

DetectX-Rv-v2 – Product Status 171

DetectX-Rv-v2 – Product Description 171

PaxGenBio Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 172

PaxView COVID-19 real-time RT-PCR Kit – Product Status 172

PaxView COVID-19 real-time RT-PCR Kit – Product Description 172

Pepex Biomedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 173

COVID-19 Antigen Detection Test – Product Status 173

COVID-19 Antigen Detection Test – Product Description 173

PerkinElmer Inc Pipeline Products & Ongoing Clinical Trials Overview 174

PerkinElmer New Coronavirus Nucleic Acid Detection Kit – Saliva – Product Status 174

PerkinElmer New Coronavirus Nucleic Acid Detection Kit – Saliva – Product Description 174

PharmaCyte Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 175

ERT-PCR SARS-CoV-2 Test – Product Status 175

ERT-PCR SARS-CoV-2 Test – Product Description 175

PrimerDesign Ltd Pipeline Products & Ongoing Clinical Trials Overview 176

COVID-19 Genesig Real-Time PCR Assay – Product Status 176

COVID-19 Genesig Real-Time PCR Assay – Product Description 176

Qiagen NV Pipeline Products & Ongoing Clinical Trials Overview 177

artus SARS-CoV-2 Prep&Amp UM Kit – Product Status 177

artus SARS-CoV-2 Prep&Amp UM Kit – Product Description 177

QIAprep&amp Viral RNA UM Kit – Product Status 178

QIAprep&amp Viral RNA UM Kit – Product Description 178

QuantuMDx Group Ltd Pipeline Products & Ongoing Clinical Trials Overview 179

QuantuMDx SARS-CoV-2 RT-PCR Detection Assay – Product Status 179

QuantuMDx SARS-CoV-2 RT-PCR Detection Assay – Product Description 179

SARS-CoV-2 Saliva Test – Product Status 180

SARS-CoV-2 Saliva Test – Product Description 180

RayBiotech Inc Pipeline Products & Ongoing Clinical Trials Overview 181

1-Step COVID-19 PCR Collection Buffer – Product Status 181

1-Step COVID-19 PCR Collection Buffer – Product Description 181

Reagent Genie Ireland Ltd Pipeline Products & Ongoing Clinical Trials Overview 182

COVID-19 (SARS-CoV-2) Triplex RT-qPCR Detection Kit – Product Status 182

COVID-19 (SARS-CoV-2) Triplex RT-qPCR Detection Kit – Product Description 182

Reliance Life Sciences Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 183

R-Green Kit – Product Status 183

R-Green Kit – Product Description 183

RTA Laboratories Pipeline Products & Ongoing Clinical Trials Overview 184

Diagnovital SARS-CoV-2 Real-Time PCR Kit – Product Status 184

Diagnovital SARS-CoV-2 Real-Time PCR Kit – Product Description 184

RTA Laboratories Biological Products Pharmaceutical and Machinery Industry Pipeline Products & Ongoing Clinical Trials Overview 185

Diagnovital SARS-CoV-2 Multiplex – Product Status 185

Diagnovital SARS-CoV-2 Multiplex – Product Description 185

Sacace Biotechnologies Srl Pipeline Products & Ongoing Clinical Trials Overview 186

COVID-19 SARS-Cov-2 Real-TM – Product Status 186

COVID-19 SARS-Cov-2 Real-TM – Product Description 186

SD Biosensor Inc Pipeline Products & Ongoing Clinical Trials Overview 187

STANDARD M nCoV Real-Time Detection kit – Product Status 187

STANDARD M nCoV Real-Time Detection kit – Product Description 187

Seegene Inc Pipeline Products & Ongoing Clinical Trials Overview 188

Allplex SARS-Cov-2 Assay – Product Status 188

Allplex SARS-Cov-2 Assay – Product Description 188

Selfdiagnostics OU Pipeline Products & Ongoing Clinical Trials Overview 189

SDx SARS-CoV-2 RNA Test – Product Status 189

SDx SARS-CoV-2 RNA Test – Product Description 189

Sentebiolab Biotechnology Pipeline Products & Ongoing Clinical Trials Overview 190

Senteligo Covid-19 qRT PCR Detection Kit – Product Status 190

Senteligo Covid-19 qRT PCR Detection Kit – Product Description 190

Shandong Shtars Biological Industry Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 191

Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit – Product Status 191

Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit – Product Description 191

Shanghai Fosun Long March Medical Science Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 192

Fosun COVID-19 RT-PCR Detection Kit – Product Status 192

Fosun COVID-19 RT-PCR Detection Kit – Product Description 192

Shenzhen Second People’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 193

Nucleic Acid Assay – COVID-19 – Product Status 193

Nucleic Acid Assay – COVID-19 – Product Description 193

Shenzhen Second People’s Hospital – Ongoing Clinical Trials Overview 194

Nucleic Acid Assay – COVID-19 – Development and Application of a Novel High Sensitivity Nucleic Acid Assay for Novel Coronavirus Pneumonia (COVID-19) Based on CRISPR-cas Protein 195

Simon Fraser University Pipeline Products & Ongoing Clinical Trials Overview 196

Mango NASBA Test – COVID-19 – Product Status 196

Mango NASBA Test – COVID-19 – Product Description 196

Sinsoma GmbH Pipeline Products & Ongoing Clinical Trials Overview 197

Novel SARS-CoV-2 Test – Product Status 197

Novel SARS-CoV-2 Test – Product Description 197

Summit Biolabs Inc Pipeline Products & Ongoing Clinical Trials Overview 198

Saliva Based Liquid Biopsy Test – COVID-19 – Product Status 198

Saliva Based Liquid Biopsy Test – COVID-19 – Product Description 198

TBG Diagnostics Ltd Pipeline Products & Ongoing Clinical Trials Overview 199

ExProbe SARS-CoV-2 Testing Kit – Product Status 199

ExProbe SARS-CoV-2 Testing Kit – Product Description 199

TCM Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 200

TCM-Q Corona III Diagnostic Kit – Product Status 200

TCM-Q Corona III Diagnostic Kit – Product Description 200

TCM Ltd Pipeline Products & Ongoing Clinical Trials Overview 201

Diagnostic Primer Test – SARS-CoV-2 – Product Status 201

Diagnostic Primer Test – SARS-CoV-2 – Product Description 201

Thermo Fisher Scientific Inc Pipeline Products & Ongoing Clinical Trials Overview 202

TaqCheck SARS-CoV-2 Fast PCR Assay – Product Status 202

TaqCheck SARS-CoV-2 Fast PCR Assay – Product Description 202

TaqPath COVID-19 Combo Kit – Pooled Specimens – Product Status 203

TaqPath COVID-19 Combo Kit – Pooled Specimens – Product Description 203

ThermoGenesis Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 204

RT-PCR COVID-19 Test – Product Status 204

RT-PCR COVID-19 Test – Product Description 204

Todos Medical Pipeline Products & Ongoing Clinical Trials Overview 205

Todos 2019-nCoV RT-qPCR Detection Kit – Product Status 205

Todos 2019-nCoV RT-qPCR Detection Kit – Product Description 205

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

NATSure COVID-19 SinglePlex Real-time PCR Kit – Product Status 206

NATSure COVID-19 SinglePlex Real-time PCR Kit – Product Description 206

University College London Pipeline Products & Ongoing Clinical Trials Overview 207

COPAN Swabbing And Blood Sample Collection Test – Product Status 207

COPAN Swabbing And Blood Sample Collection Test – Product Description 207

University College London – Ongoing Clinical Trials Overview 208

COPAN Swabbing And Blood Sample Collection Test – COVID-19: Healthcare Worker Bioresource: Immune Protection and Pathogenesis in SARS-CoV-2 209

University of East Anglia Pipeline Products & Ongoing Clinical Trials Overview 210

Portable Test Kit – COVID-19 – Product Status 210

Portable Test Kit – COVID-19 – Product Description 210

University of Hong Kong Pipeline Products & Ongoing Clinical Trials Overview 211

RT-PCR Assay – ORF1b – Product Status 211

RT-PCR Assay – ORF1b – Product Description 211

University of Rhode Island Pipeline Products & Ongoing Clinical Trials Overview 212

Saliva Based COVID-19 Test – Product Status 212

Saliva Based COVID-19 Test – Product Description 212

University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 213

Two-Step COVID-19 Test – Product Status 213

Two-Step COVID-19 Test – Product Description 213

University of Washington School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 214

SARS-CoV-2 PCR Test – Product Status 214

SARS-CoV-2 PCR Test – Product Description 214

Vazyme Biotech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 215

2019-Novel Coronavirus Triplex RT-qPCR Detection Kit – Product Status 215

2019-Novel Coronavirus Triplex RT-qPCR Detection Kit – Product Description 215

Veredus Laboratories Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 216

VereRTCoV 3.0 ZeroStep Real-Time RT-PCR – Product Status 216

VereRTCoV 3.0 ZeroStep Real-Time RT-PCR – Product Description 216

VIC Foundry Inc Pipeline Products & Ongoing Clinical Trials Overview 217

Molecular Diagnostic Test – COVID-19 – Product Status 217

Molecular Diagnostic Test – COVID-19 – Product Description 217

Virgi

List of Figures

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Stage of Development 22

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Territory 23

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Regulatory Path 25

COVID 19 Nucleic Acid Amplification Tests (NAATs) – Pipeline Products by Estimated Approval Date 26

Frequently Asked Questions

The key countries in the COVID-19 NAAT pipeline product market are the US, Canada, Europe, India, China, Brazil, Indonesia, Israel, Japan, Kuwait, Malaysia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Argentina, Ecuador, Mexico, Peru, Russia, Uruguay, and Vietnam.

The key stages of development in the COVID-19 NAAT pipeline product market are early development, clinical, in-approval, and inactive.

The key companies in the COVID-19 NAAT pipeline product market are 1drop Inc, 3D Medicines Inc, 4basebio AG, 8 Billion Inc, Aanika Biosciences Inc, Access Medical Labs, Acumen Research Laboratories Pte Ltd., Advanced MedTech Holdings Pte Ltd, Aegea Biotechnologies Inc, Agappe Diagnostics Ltd, Agena Bioscience Inc, Aldatu Biosciences Inc, Altona Diagnostic GmbH, American Biosources Inc, and Applied Biological Materials Inc.

 

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