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신종 코로나바이러스(COVID-19) 진단, 기술, 참여 기업, 동향

COVID-19 Diagnostics, Technologies, Players and Trends

리서치사 IDTechEx Ltd.
발행일 2020년 05월 상품 코드 932907
페이지 정보 영문 182 Slides
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신종 코로나바이러스(COVID-19) 진단, 기술, 참여 기업, 동향 COVID-19 Diagnostics, Technologies, Players and Trends
발행일 : 2020년 05월 페이지 정보 : 영문 182 Slides

COVID-19는 SARS-CoV-2가 원인인 감염증으로, 중국에서 첫 증례가 보고된 2019년 12월에 발생이 시작되었습니다. WHO는 2020년 3월 11일에 COVID-19의 발생을 팬데믹으로 인정했습니다. 2020년 4월까지 확정 증례 수가 200만 건을 넘으며 많은 국가의 경제에 타격을 주고 있습니다.

세계의 COVID-19 진단 기술에 대해 COVID-19의 최신 동향과 함께 다양한 기술의 100개 이상 기기를 벤치마크하고, 일부 기업을 소개하면서 기술 동향을 상세 검증하여 전해드립니다.

제1장 개요

제2장 서론

  • 감염증이란?
  • 역사적으로 감염증은 주요 사인이었다.
  • 감염증이 팬데믹으로 연결될 가능성
  • COVID-19는 신종 코로나바이러스 SARS-CoV-2에 의한 감염증
  • 감염증 진단의 주요 기술
  • 현미경과 배양 증식 방법은 신속한 바이러스 검출에는 적절하지 않다.
  • COVID-19 진단 기술의 개요
  • 바이오마커 등

제3장 분자진단이 COVID-19 진단의 골드 스탠다드

  • 분자진단이 COVID-19 진단의 중심
  • 기술 : 정량적 역전사 중합효소 연쇄반응(qRT-PCR)
  • 기술 : 등온 증폭
  • 기술 : DNA 시퀀싱

제4장 POC(Point-of-Care)에서의 신규 분자진단

  • 소형화에 의해 가능해지는 POC 분자진단
  • POC(Point-of-Care) 분자진단이 COVID-19 진단의 시료 채취로부터 판정까지의 시간을 가속
  • POC(Point-of-Care) 분자진단 검사의 구조
  • 진단 시장에 미치는 영향 등

제5장 측방유동 어세이 신속 검사

  • 감염증 검출을 위한 상업화된 주요 방법 중 하나
  • 다양한 용도에 폭넓게 사용된다.
  • 바이오마커와 바이오리셉터
  • 면역분석법
  • 측방유동 면역분석법의 메커니즘
  • ELISA
  • 측방유동 어세이 스트립의 재료와 제조 등

제6장 하이브리드 진단

  • 하이브리드 진단 어세이 : 성능, 스피드, 가격의 트레이드 오프
  • Luminex
  • Mesa Biotech
  • CRISPR-Cas
  • Octant
  • BillionToOne

제7장 기타 기술 혁신

  • 냄새에 의한 진단
  • 호기에 의한 진단
  • 생물학적 패턴에 의한 진단과 모니터링
  • 진단을 위한 AI
  • 주요 참여 기업
  • Infervision
  • 기타 기업
  • COVID-19 검출 AI : 알고리즘 비교
KSA 20.04.29

"Demand for testing is over 600 million including 100m genetic tests and over 500m rapid tests."

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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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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