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COVID-19 診断: IDTechEx

Demand for testing in billions with 250m genetic tests and over 500m rapid tests at the moment

COVID-19 診断

技術、有力企業およびトレンド


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COVID-19 検査の需要は、1億2,000万回の遺伝子検査ならびに5億回を超える迅速検査を含め検査回数は6億回を超える規模となっています。このレポートにおいて弊社は様々な技術にまたがる100種以上の商用装置を評価し、COVID-19 への世界の対応を巡る技術トレンドやバイオ分野のイノベーションに関する確かな知見を提供しています。
COVID-19 is an infectious disease caused by SARS-CoV-2. The outbreak of COVID-19 started in Dec. 2019 with the first case reported in China. The World Health Organization (WHO) recognised the outbreak of COVID-19 as a pandemic on 11 March 2020. By April 2020, there are over 2 million confirmed cases and have brought the economies of many countries to a halt.
 
Diagnostic testing is possibly the only efficient way to know the spread of the SARS-CoV-2 in time and space, enabling policymakers and healthcare workers to track and mitigate the outbreak of COVID-19. The WHO has appealed for global mass testing. The demand for COVID-19 testing is estimated to be over 600 million tests including 120 million genetic tests and over 500 million rapid tests.
 
The need for universal and massive testing across the population has led to a race for technology innovations for COVID-19 diagnostics. This report surveys the technology landscape, with an in-depth analysis of the technology innovations that are enabling a quick access to COVID-19 diagnosis in response to the global pandemic.
 
Molecules derived from the virus—nucleic acids like RNA or DNA, or proteins—form the basis of diagnostics as well as being essential for developing new therapies and vaccines. Depending on the target biomarkers, the diagnostic methods can be separated into two categories: genetic testing (detecting the viral genome) and serological & antigenic testing (detecting antibodies and viral antigens, respectively). From the technological perspective, molecular diagnostics (MDx) and lateral flow assays (LAFs) dominate COVID-19 diagnostics. The gold standard used across clinical laboratories is quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR, MDx), which requires a central lab setting. Such qRT-PCR testing lasts for more than 2 hour and the sample shipment cost up to several days. With the demand for quicker tests at community settings, the market is moving into point-of-care (POC) devices, including POC MDx and POC LFAs.
 
All molecular diagnostics tests detecting viral genomes share three common steps: sample collection from Nasopharyngeal swab and extraction of viral RNA, amplification of the analyte and read-out. The amplification step is performed reliably by RT-PCR, however alternatives that do not require expensive and bulky equipment exist, i.e. isothermal amplification. This approach, although less sensitive than PCR, allows for a quicker amplification step at a constant temperature.
 
The read-out of the amplified signal is normally achieved through fluorescence probes in the sample and detectors in qRT-PCR devices. Many companies have resorted to lateral flow assays and alternative read-out methods that require proprietary detection equipment. These "hybrid systems" benefit from the high specificity and sensitivity of MDx and the speed and low cost of LFAs.
 
This report identifies key innovations and technology trends currently being developed in the diagnostics ecosystem that will enable quick and sensitive diagnosis of COVID-19 at point-of-care settings:
 
Apart from genetic testing, antigenic tests and serological tests, so-called ¨rapid tests¨, are also becoming central tools in the fight against the pandemic. Both types of immunoassays rely on antibody-antigen recognition. Antigen tests are able to detect the presence of viral proteins in the blood All molecular diagnostics tests detecting viral genomes share three common steps: sample collection from Nasopharyngeal swab and extraction of viral RNA, amplification of the analyte and read-out. The amplification step is performed reliably by RT-PCR, however alternatives that do not require expensive and bulky equipment exist, i.e. isothermal amplification. This approach, although less sensitive than PCR, allows for a quicker amplification step at a constant temperature.
 
The read-out of the amplified signal is normally achieved through fluorescence probes in the sample and detectors in qRT-PCR devices. Many companies have resorted to lateral flow assays and alternative read-out methods that require proprietary detection equipment. These "hybrid systems" benefit from the high specificity and sensitivity of MDx and the speed and low cost of LFAs.
 
This report identifies key innovations and technology trends currently being developed in the diagnostics ecosystem that will enable quick and sensitive diagnosis of COVID-19 at point-of-care settings:
 
Apart from the effort from biotech, multiple software companies have developed algorithms to identify signs of COVID-19-related pneumonia in patient scans. CT imaging is an effective way of detecting abnormalities indicative of COVID-19, and image recognition AI algorithms have the potential to detect these abnormalities faster and more efficiently than radiologists.
 
In this report, we benchmarked more than 100 commercial devices across various technologies, providing a deep insight into the technology trends and biotech innovations surrounding the COVID-19 global response. Some of the companies mentioned in the report:
 
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アイディーテックエックス株式会社 (IDTechEx日本法人)
担当: 村越美和子 m.murakoshi@idtechex.com
Table of Contents
1.EXECUTIVE SUMMARY
1.1.COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2
1.2.Overview of the technologies for COVID-19 diagnostics
1.3.Performance comparison of different technologies for COVID-19 diagnostics
1.4.Molecular diagnostics sits at the heart of COVID-19 diagnostics
1.5.US companies lead the COVID-19 molecular diagnostics test
1.6.Real-Time PCR/ Quantitative PCR (qPCR)
1.7.Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
1.8.Genetic testing for COVID-19
1.9.Amplification: isothermal amplification as alternative
1.10.Digital PCR (dPCR) for COVID-19 diagnostics are being developed
1.11.Antibody and antigen test
1.12.Lateral flow assays enable rapid tests of COVID-19
1.13.Antibody and antigen test: enzyme-linked immunosorbent assay (ELISA)
1.14.Highly sensitive and specific immunoassays: big equipment and longer testing time
1.15.Countries are struggling to find good quality rapid test kits
1.16.Chinese companies dominate the LFAs market for COVID-19 test
1.17.Key trends in COVID-19 diagnostics innovations
1.18.Point-of-Care Molecular Diagnostics accelerate the sample-to-answer time for COVID-19 diagnostics
1.19.Isothermal amplification will replace PCR?
1.20.Hybrid diagnostics assays: trade-off between performance, speed and price
1.21.Omit RNA extraction?
1.22.CRISPR-Cas based diagnostics
1.23.The role of DNA sequencing in COVID-19 detection
1.24.Combine of PCR and DNA sequencing for high through-put COVID-19 diagnostics
1.25.Market landscape for post COVID-19
2.INTRODUCTION
2.1.What are infectious diseases?
2.2.Historically infectious diseases have been the leading cause of death
2.3.Infectious diseases may lead to a pandemic
2.4.COVID-19 is an infectious disease caused by the novel coronavirus SARS-CoV-2
2.5.COVID-19 as a pandemic
2.6.Epidemiology of Covid-19
2.7.Main techniques to diagnose infectious diseases
2.8.Microscopy and culture growth methods are not suitable for fast virus detection
2.9.Overview of the technologies for COVID-19 diagnostics
2.10.Biomarkers for COVID-19
2.11.RNA genome as biomarker
2.12.Mass testing for COVID-19
2.13.Sample-to-answer time for different diagnostic technologies
2.14.Sensitivity and specificity
2.15.Sensitivity and specificity for different diagnostic technologies
2.16.Performance comparison of different technologies for COVID-19 diagnostics
2.17.Key trends in COVID-19 diagnostics innovations
3.MOLECULAR DIAGNOSTICS IS THE GOLD STANDARD FOR COVID-19 DIAGNOSTICS
3.1.1.Molecular diagnostics sits at the heart of COVID-19 diagnostics
3.1.2.US companies lead the COVID-19 molecular diagnostics test
3.1.3.Working flow of MDx devices
3.1.4.Detection methods are being used commercially
3.1.5.Fluorescence detection is the top option
3.1.6.Electrochemical detection: label free
3.2.Technology: Quantitative reverse transcription-polymerase chain reaction (qRT-PCR)
3.2.1.Polymerase chain reaction (PCR): Introduction
3.2.2.Polymerase chain reaction (PCR): Process
3.2.3.Real-time reverse transcription-polymerase chain reaction is the most popular choice
3.2.4.Real-Time PCR/ Quantitative PCR (qPCR)
3.2.5.Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
3.2.6.qRT-PCR is the gold standard to diagnose COVID-19
3.2.7.RNA extraction is a bottleneck for many laboratories
3.2.8.Droplet Digital PCR (ddPCR, Bio-Rad)
3.2.9.Digital PCR (dPCR) for COVID-19 diagnostics are being developed
3.2.10.Key players for PCR devices
3.2.11.Key players for PCR reagents/consumables
3.2.12.Market share for PCR equipment For COVID-19 diagnostics
3.3.Technology: Isothermal amplification
3.3.1.Isothermal amplification of nucleic acids
3.3.2.Overview of Isothermal Amplification Technologies I
3.3.3.Overview of Isothermal Amplification Technologies II
3.3.4.Which is the future: isothermal amplification or PCR?
3.3.5.Isothermal amplification based COVID-19 diagnostics
3.4.Technology: DNA sequencing
3.4.1.The role of DNA sequencing in COVID-19 detection
3.4.2.DNA sequencing
3.4.3.DNA sequencing technology: first generation
3.4.4.Capillary Electrophoresis DNA sequencers
3.4.5.Next generation sequencing (NGS)
3.4.6.Second generation sequencing workflows (Illumina)
3.4.7.Key players for second generation sequencing
3.4.8.3rd generation sequencing
3.4.9.Key players for third generation sequencing
3.4.10.Cost of DNA sequencing is dropping
3.4.11.Future trends and opportunities
3.4.12.Lists of qRT-PCR test kits with approval for COVID-19 diagnostics (excl. POC MDx) (1)
3.4.13.Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (2)
3.4.14.Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (3)
3.4.15.Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (4)
3.4.16.Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (5)
3.4.17.Lists of qRT-PCT test kits with approval for COVID-19 diagnostics (excl. POC MDx) (6)
3.4.18.Roche molecular systems: Cobas SARS-CoV-2
3.4.19.BGI Genomics: Real-Time SARS-CoV-2 Test
3.4.20.PerkinElmer: New Coronavirus Nucleic Acid Detection Kit
3.4.21.Quest Diagnostic: SARS-CoV-2 RNA, qRT-PCR
3.4.22.Quidel: Lyra SARS-CoV-2 Assay
3.4.23.Primerdesign COVID-19 genesig Real-Time PCR assay
3.4.24.Gnomegen: COVID-19 RT-Digital PCR Detection Kit
3.4.25.Vision Medicals: SARS-CoV-2 Clinical Sequencing assay
4.EMERGING MOLECULAR DIAGNOSTICS AT POINT-OF-CARE
4.1.Miniaturised devices enable molecular diagnostics at point-of-care
4.2.Molecular diagnostics is moving to point-of-care
4.3.The Rise of Point-of-Care Molecular Diagnostics
4.4.Point-of-Care Molecular Diagnostics accelerate the sample-to-answer time for COVID-19 diagnostics
4.5.What constitutes a Point-of-Care MDx test?
4.6.What it takes to win in point-of-care molecular diagnostics
4.7.The value of point-of-care testing
4.8.The importance of POC biosensors and comparison to centralised testing
4.9.Examples of POC MDx devices
4.10.Costing of test kits for POC MDx devices
4.11.POC MDx: Atlas io system
4.12.POC MDx: Cobas Liat
4.13.POC MDx: Alere i
4.14.POC MDx: Alere q Analyzer
4.15.POC MDx: Spartan Cube
4.16.POC MDx: FilmArray 2.0
4.17.POC MDx: PanNAT system
4.18.POC MDx: GeneXpert Omni
4.19.POC MDx: Spartan Cube
4.20.POC MDx: Q-POC
4.21.Additional POC MDx: systems
4.22.Lists of POC MDx kits with approval for COVID-19 diagnostics
4.23.Cepheid: Xpert® Xpress SARS-CoV-2
4.24.Abbott: ID NOW™ COVID-19 rapid test
4.25.Technology for ID NOW™ COVID-19 rapid test
4.26.bioMérieux: BioFire COVID-19 Test
4.27.DiaSorin Molecular: Simplexa COVID-19 Direct assay
5.IMMUNOASSAYS
5.1.Immunoassays
5.2.Antibody and antigen test
5.3.Lateral flow assays (LFAs) is one of the main commercialised methods to detect infectious disease
5.4.Lateral flow assays is widely used for various applications
5.5.Biomarker and bioreceptor: antigens and antibodies
5.6.Mechanisms of lateral flow immunoassays
5.7.Materials and manufacturing of lateral flow assay strips
5.8.Point-of-care molecular diagnostic (POC MDx) is taking over the infectious disease market from lateral flow assays
5.9.MDx or LFAs
5.10.Lateral flow assays enable rapid tests of COVID-19
5.11.Enzyme-linked immunosorbent assay (ELISA)
5.12.Antigenic tests
5.13.Serological test
5.14.Chinese companies dominate the LFAs market for COVID-19 test
5.15.Countries are struggling to find good quality rapid test kits
5.16.Rapid tests purchased by Spain
5.17.Rapid tests purchased by the UK
5.18.List of LAFs test kits with approval for COVID-19 diagnostics (1)
5.19.List of LAFs test kits with approval for COVID-19 diagnostics (2)
5.20.List of LAFs test kits with approval for COVID-19 diagnostics (3)
5.21.Cellex: qSARS-CoV-2 IgG/IgM Rapid Test
5.22.Roche: Elecsys Anti-SARS-CoV-2 serology test
5.23.Abbott: serology test
5.24.Bio-Rad: Platelia SARS-CoV-2 Total Ab assay
5.25.Quidel: Sofia 2 SARS Antigen FIA Test
6.HYBRID DIAGNOSTICS SYSTEMS
6.1.Hybrid diagnostics assays: trade-off between performance, speed and price
6.2.Lateral flow assays to detect DNA biomarkers
6.3.MDx with electrochemical detection without label
6.4.Luminex Molecular Diagnostics: NxTAG CoV Extended Panel Assay
6.5.Luminex: xMAP Technology
6.6.Mesa Biotech: Accula SARS-Cov-2 Test
6.7.CRISPR-Cas based diagnostics
6.8.CRISPR-Cas based diagnostics work flow
6.9.Competition of CRISPR-Cas based diagnostics
6.10.Other player in CRISPR technology for COVID-19 testing
6.11.Combine of PCR and DNA sequencing for high through-put COVID-19 diagnostics
6.12.Octant: next generation sequencing for mass COVID-19
6.13.BillionToOne: sanger sequencing for large scale COVID-19 testing
7.OTHER TECHNOLOGY INNOVATIONS
7.1.COVID-19 diagnostics via smell
7.2.COVID-19 diagnostics via breath
7.3.COVID-19 diagnostics and monitoring via biological patterns
7.4.AI for COVID-19 diagnostics
7.5.AI for COVID-19: Key players
7.6.AI for COVID-19: Infervision
7.7.AI for COVID-19: Other companies
7.8.COVID-19 detection AI: Algorithm comparison
 

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