At-Home Testing: COVID-19 Trends and Future Potential

Table of Contents

Chapter 1:  Executive Summary

• Background
• Scope and Methodology
  • United States of America
  • Canada
  • Europe
  • United Kingdom
• Definitions
• Point of View
  • Table 1-1 Speculative Projection of Home Testing for Test Categories FY 2021 (COVID-19, UTIs, STDs, HIV, Cholesterol and Other Categories)

Chapter 2: Government Support for COVID-19 Home Tests

• Background
• S. EUA Tests and Home Test Services
• Canada’s COVID-19 Test Initiative
  • Table 2-1 Number of Canada Authorized COVID-19 Testing Devices (Rapid Point-Of-Care, Antigen Testing Devices, Nucleic Acid Testing Devices [PCR], and Serological Testing Devices)

Resources

• COVID-19 Test Initiatives in Europe and the UK
  • Table 2-2 Selected CE Marked Rapid, POC COVID-19 Tests (Abbott Laboratories, Cellex, Coris Bioconcept, Cue Health, HiberGene Diagnostics, Laipac Technology, LumiraDX, Mast Group, Mologic, MP Biomedicals, PerkinElmer, Roche Diagnostics, SD Biosensors, and Siemens Healthineers)

Chapter 3: COVID-19 Home Test Sample Types

• Background
  • Table 3-1 Major Sample Types Used in Rapid Diagnostic Tests For COVID-19 (Nasopharyngeal Swab, Anterior Nasal Swab, Saliva, and Breath)
• Sample Self Collection Kits
  • Table 3-2 Selected COVID-19 Authorized Sample Collection Kits (Amazon, BioReference Laboratories, GenMark/Roche Diagnostics, Gravity Diagnostics, Laboratory Corp. America [LabCorp], LetsGetChecked, Quest Diagnostics, RapidRona, Walgreens, Color, DxTerity Diagnostics, Fluidigm, hims & hers, OraSure Technologies, Phosphorus Diagnostics, Thermo Fisher Scientific, Vitagene, and MicroGenDx)
• Nasal Swabs Maintain Market Dominance
  • Table 3-3 Selected COVID-19 Self-Tests Using A Nasal Swab (Abbott Labs, Becton Dickinson & Co [BD], Cue Health, Ellume, Eurofins Clinical Enterprise, Fulgent Genetics, Iowa State University, Laipac Technology, Lucira Health, Quidel Corp., Siemens Healthineers)
• Saliva Sampling Gains Popularity
  • Table 3-4 Selected Saliva-Based Self-Tests for COVID-19 (Clinical Reference Laboratory, Fluidigm, Hoth Therapeutics, Medusa 19, Nuclein, OraSure Technologies, Vault Health, and Vitagene)
• Alternative Sampling Innovations
  • Table 3-5 Selected COVID-19 Tests Using Alternate Samples (Breathonix, Canary Health Technologies, Gadjah Mada University, GreyScan, Next-Gen, Northumbria University, Ohio State University, Scentech Medical, and PerkinElmer)

Chapter 4: COVID-19 Home Test Modalities

• Background
  • Table 4-1 Major Test Technologies Used in Rapid Diagnostic Tests for COVID-19 (PCR, EIA, LF EIA, CRISPR, Biosensor, LAMP)
• Traditional Molecular – PCR, LAMP
  • Table 4-2Selected Home and POC Molecular COVID-19 Tests (Abbott Labs, BioFire Diagnostics/biomérieux,Cepheid, Clinical Reference Laboratory, Cue Health, Fluidigm, Fulgent Genetics, GenMark/Roche Diagnostics, HiberGene Diagnostics, Lucira Health, Mesa Biotech, OralDNA Labs, Vault Health, and Vitagene)
• CRISPR & Biosensors
  • Table 4-3 Selected CRISPR and Biosensor–Based Devices for COVID-19 Testing (Arizona State University, Bilkent University, Blink Science, GLC Medical, Hoth Therapeutics, Identify Sensors Biologics, Iowa State University, Pennsylvania State University, Broad Institute of MIT, CSIR-Institute of Genomics, Gladstone Institutes, Mammoth Biosciences, and Sherlock Biosciences)
• COVID-19 Antigen Testing By Immunoassay
  • Table 4-4 Selected FDA EUA and CE Marked COVID-19 Antigen Immunoassays (Abbott Labs, AccessBio, Becton Dickinson & Co [BD] Ellume, Laipac Technology, Mast Group, Medusa 19, Mologic, PerkinElmer, Quidel Corp., Roche Diagnostics, SD Biosensor, and Siemens Healthineers)
• COVID-19 Antibody Tests by Immunoassay
  • Table 4-5 Selected FDA EUA and CE Marked COVID-19 Antibody Immunoassays (Assure Tech, bioLytical Laboratories, bio Mérieux, Cellex, Eurofins Technologies, Healgen Scientific, NovaBay Pharmaceuticals, NOWDiagnostics, PerkinElmer, Quest Diagnostics, SD Biosensor, Vatic, and Verify Diagnostics)

Chapter 5: Rapid COVID-19 Tests Migrate to OTC and DTC Venues

• Background
• OTC and DTC Initiatives
  • Table 5-1 Selected OTC and DTC COVID-19 Test Initiatives (Abbott Labs, Becton Dickinson & Co [BD], Clinical Reference Laboratory, Cue Health, Ellume, Laboratory Corp. America [LabCorp], Laipac Technology, Lucira Health, Quest Diagnostics, and Quidel Corp.)
• And Now For Something A Little Bit Different
  • Table 5-2 Selected Novel COVID-19 Test Initiatives (3M, Fitbit, Identify Sensors Biologics, Johns Hopkins University, NeuTigers, Northwestern University, and Pennsylvania State University)

Chapter 6: COVID-19 Self and Home Testing in the Post Pandemic Era

• Background
• What Is The Status Quo
• The Future For Home Covid-19 Tests

Chapter 7: Company Summaries

• Background
• Abbott Laboratories
• Becton Dickinson & Company (BD)
• Biomérieux / Biofire Diagnostics
• Cepheid, a Danaher Company
• Fluidigm Corporation
• Genmark Diagnostics, Inc.
• LetsGetChecked/PrivaPath Diagnostics Limited
• Lucira Health
• Mesa Biotech
• Orasure Technologies, Inc.
• QIAGEN N.V.
• Quidel Corporation
• Roche Diagnostics
• Sherlock Biosciences