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

Published: | Kalorama Information | 92 Pages | Delivery time: 1-2 business days


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At-Home Testing: COVID-19 Trends and Future Potential
Published: April 15, 2021
Kalorama Information
Content info: 92 Pages
Delivery time: 1-2 business days
  • ALL
  • Description
  • Table of Contents

This first edition report “ At-Home Testing: COVID-19 Trends and Future Potential ” provides an overview of trends and developments in the home testing industry for the pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This report covers trends that have occurred since the pandemic was declared in 2020 to the recent present - March 31, 2021.

For the purpose of this report, Kalorama Information concludes that the accepted definition of a home or self-test is one whereby the individual takes the sample, performs the test and then interprets the test result either alone or with the aid of an online consultation service. As of the time of publication in Spring 2021, the major market for COVID-19 self-tests is the United States, therefore the discussion presented in the report focuses on that geography.

Many non-instrumented point-of-care (POC) COVID-19 tests use immunoassays and molecular technologies. They have not been officially designated as home tests but do have the potential to migrate to home-based tests as is deemed necessary by public health agencies. These COVID-19 point-of-care molecular tests are therefore included in this Kalorama Information report.

The report discusses COVID-19 tests and technologies that are currently available and those that are expected to take their place. The report covers trends and issues concerning:

  • government support for COVID-19 home tests
  • COVID-19 home test sample types
  • COVID-19 home test modalities
  • OTC and DTC trends in COVID-19 testing

In addition to the various aforementioned trends, tests, and technologies covered in the report, “ At-Home Testing: COVID-19 Trends and Future Potential ” profiles several companies active in this market, including:

  • Abbott Laboratories
  • Becton Dickinson & Company (BD)
  • bioMérieux / BioFire Diagnostics
  • Cepheid, A Danaher Company
  • Fluidigm Corporation
  • GenMark Diagnostics, Inc., A Roche Diagnostics Company
  • LetsGetChecked/PrivaPath Diagnostics Limited
  • Lucira Health
  • LumiraDx
  • Mesa Biotech
  • OraSure Technologies, Inc.
  • Quidel Corporation
  • Roche Diagnostics
  • Sherlock Biosciences
  • Siemens Healthineers
Table of Contents
Product Code: 21-052

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.
  • Quidel Corporation
  • Roche Diagnostics
  • Sherlock Biosciences