COVID-19 IVD Test Tracker

Kalorama’s latest report reports that more than 9 billion will be earned by IVD companies selling both molecular and immunoassay tests.? 9,040 million dollars.? The worldwide COVID-19 crisis has spawned hundreds of diagnostic testing kits and daily announcements.? How do you sort out the significant tests with large distribution and market share from promising startups or low volume companies? This Kalorama COVID-19 IVD Test Tracker will update on new EUAs with information and analysis from Kalorama analysts, updated on a regular basis.? Kalorama Information has covered diagnostics for 2 decades.

Antigen Tests on the Market or in Development

Antigen tests, most of which are performed rapidly at the point of care, detect viral particles rather than antibodies in the patient. They can offer some major benefits in the effort to control the SARS-CoV-2 pandemic.

The decision to apply antigen tests in certain situations as opposed to others is complicated and is still being completely sorted out. Variables can include:

  • Sensitivity and specificity of the test
  • Prevalence/outbreak of COVID-19 in the given population
  • Remote location, availability of laboratories/hospitals
  • Turnaround time of the test
  • Cost of the test
  • Ability to perform serial testing

Following are a list of antigen tests on the market or in development.? Most are rapid test designed for a point-of care setting, but increasingly lab-based tests are in development and being employed in CE mark-accepting countries.

Abbott Laboratories BinaxNow COVID-19 Ag Card & Navica app
Abbott Laboratories Panbio COVID-19 Ag Rapid Test Device
Access Bio CareStart COVID-19 Antigen
BD BD Veritor System for Rapid Detection of SARS-CoV-2
Celltrion Sampinute COVID-19 Antigen MIA
Genomic Vision Coronadiag Ag
LumiraDx SARS-CoV-2 Ag Test
Menarini Diagnostics (excl Europe distr for Boditech Med) iChroma COVID-19
Menarini Diagnostics (excl Europe distr for Boditech Med) AFIAS COVID-19 AG
OraSure Technologies at-home test
Quidel Sofia SARS Antigen FIA
Quidel Sofia 2 Flu + SARS Antigen FIA
Roche SARS-CoV-2 Rapid Antigen Test
Roche Elecsys Anti-SARS-CoV-2 Antigen Test
DiaSorin Liaison SARS-CoV-2 Ag test
Abace Biology COVID-19 Viral Antigen Test Kit
Abace Biology COVID-19 Viral Antigen Test Kit
Abwiz Bio RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit
Alfa Scientific Designs Instant-view PLUS COVID-19 Antigen Test
AllTest Biotech COVID-19 Antigen Rapid Test
AllTest Biotech COVID-19 Antigen Rapid Test
AllTest Biotech COVID-19 Antigen Rapid Test cassette
AllTest Biotech COVID-19 and Influenza A+B Antigen Combo Rapid Test with Reader
AMEDA Labordiagnostik GmbH AMP Rapid Test SARS-CoV-2 Ag
AmonMed Biotechnology COVID-19/Influenza A virus/Influenza B virus test kit
AmonMed Biotechnology COVID-19 Antigen Test Kit
AmonMed Biotechnology COVID-19 Antigen Rapid Test Kit
Apollo Biomedical LLC [New Gene (Hangzhou) Bioengineering ??] Novel SARS-CoV-2 Coronavirus Spike Glycoprotein Detection Kit (S Protein-ACE2 receptor)
Apollo Biomedical LLC Novel SARS-CoV-2 Coronavirus/MERS-CoV/Influenza Virus A/B Multiple Antigen Detection Kit
Aptamer Group ADx SARS CoV-2 Virus Antigen Rapid Point of Care Test
ArcDia International mariPOC COVID-19 test
Assure Tech (Hangzhou) COVID-19 Antigen Rapid Test Device
Beckman Coulter Test Announced
Bioeasy Biotechnology 2019-nCoV Ag Fluorescence Rapid Test Kit
BIOHIT HealthCare SARS-CoV-2 Antigen assay kit
BIOHIT HealthCare SARS-CoV-2 Antigen Rapid Test Kit
BIOHIT HealthCare SARS-CoV-2 Antigen quantitative assay kit
Bionote NowCheck COVID-19 Ag Test
Bioperfectus Technologies PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit
Bioss SARS-CoV-2 Nucleoprotein ELISA Kit
Biosynex Swiss SA BIOSYNEX COVID-19 Ag BSS
CerTest Biotec CerTest SARS-CoV-2 card test
CerTest Biotec CerTest SARS-CoV-2 + Flu A combo; CerTest SARS-CoV-2 + Flu A+B combo; CerTest SARS-CoV-2 + Flu A+B + RSV
Confirm BioSciences Verasure COVID-19 Antigen Rapid Swab Test
CorisBioConcept COVID-19 Ag Respi-Strip
Creative Biolabs SARS-CoV-2 Antigen ELISA Kit
Deangel Biological Engineering Novel Coronavirus S Glycoprotein Detection Kit
Denka Seiken QuickNavi-COVID19
Diagreat Biotechnologies 2019-nCoV Antigen Rapid Test Kit
Dynamiker Biotechnology Dynamiker SARS-CoV-2 Ag Rapid Test
Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit
FenHe Technology reOpenTest COVID-19 Rapid Antigen Test
GaDia Diagnostics COVIDia – Antigen
GenBody GenBody COVID-19 Ag
Genesis Biodetection & Biocontrol COVID-19 Antigen Rapid Test Device
Genspeed Biotech Genspeed Ag xPOC
Genspeed Biotech COVID19 COMPLETE – IgG/Ag Test
GenSure Biotech COVID-19 Antigen Rapid Test Kit
Green Cross Medical Science Corp GENEDIA W COVID-19 Ag
Hiwow Group Novel Coronavirus(SARS-Cov-2) Antigen Rapid Test Cassette
Humasis COVID-19 Ag Test
Humasis COVID-19/Flu Ag Combo Test
Joinstar Biomedical Technology COVID-19 Antigen Rapid Test
JOYSBIO Biotechnology COVID-19 Antigen Rapid Test Kit (Colloidal Gold)
Kewei Clinical Diagnostic Reagent Kewei COVID-19 Antigen Rapid Test Kit
Kewei Clinical Diagnostic Reagent Kewei COVID-19 Antigen Rapid Test Kit
Koch Biotechnology (Beijing) SARS-CoV-2 Antigen Lateral Flow Assay
KRISHGEN BioSystems Human SARS-CoV-2 Spike Protein Antigen ELISA
KRISHGEN BioSystems Human SARS-CoV-2 Nucleocapsid Protein Antigen ELISA
L&H Biotech COVID-19/Flu A+B Antigen Combo Rapid Test Kit
LabNovation Technologies SARS-CoV-2 Antigen Rapid Test Kit
Liming Bio-Products StrongSep SARS-CoV-2 Antigen Rapid Test Kit
Liming Bio-Products Dual Biosafety System Device for SARS-CoV-2 Antigen Rapid Test
Liming Bio-Products StrongStep System Device for SARS-CoV-2 & Influenza A/B Combo Antigen Rapid Test
Luminostics Clip COVID Rapid Antigen Test
LumiQuick Diagnostics QuickProfile COVID-19 Antigen Test
LumiraDx SARS-CoV-2 Ag Test
Medakit Medakit Antigen Covid-19 Rapid Test
Medix Biochemica Actim SARS-CoV-2 test
Mologic COVID-19 Rapid Test
nal von minden NADAL COVID-19 Ag
New Gene (Hangzhou) Bioengineering COVID-19 Antigen Detection Kit
New Gene (Hangzhou) Bioengineering Novel Coronavirus Spike Glycoprotein Detection Kit (Ligand-receptor Competitive Chromatography)
New Gene (Hangzhou) Bioengineering Novel Coronavirus Antigen Detection Kit (Colloidal Gold)
New Gene (Hangzhou) Bioengineering COVID-19 Antibody / Antigen Detection Kit
Orpheus Medica CoviSafe
Pantest SA Pantest Coronavirus Ag
PCL Inc. PCL COVID-19 Ag Rapid FIA
Precision Biosensor Exdia COVID-19 Ag
PRIME4DIA P4DETECT COVID-19 Ag; P4DETECT COVID-19 SAg
Qiagen & Ellume QIAreachSARS-CoV-2 Antigen Test
Quanterix BARDA Funding for Ag Test
RapiGEN BIOCREDIT COVID-19 Ag
Savant Biotechnology New Coronavirus (SARS-CoV-2) N Protein Detection Kit
SD Biosensor STANDARD Q COVID-19 Ag
SD Biosensor STANDARD F COVID-19 Ag
Sensitest Corona Antigen Rapid Test
Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Test
Sona Nanotech Sona COVID-19 Rapid Antigen Test
Sugentech SGTi-flex COVID-19 Ag
Sure Bio-Tech 2019-nCoV Antigen Rapid Test (Colloidal Gold)
Sure Bio-Tech Diagnostic Kit for SARS-CoV-2 Ag
Tigsun Diagnostics COVID-19 Antigen Rapid Test
Tigsun Diagnostics COVID-19 Antigen Rapid Test
Tigsun Diagnostics COVID-19 Antigen Saliva Rapid Test
Willi Fox Willi Fox COVID-19 Antigen rapid test
Xiamen Boson Biotech Rapid SARS-CoV-2 Antigen Test Card
YHLO Biotech iFlash-2019-nCoV AntigenTest
YHLO Biotech UNICELL-2019-nCoV Rapid Antigen Test
Zalgen ReSARS CoV-2 Antigen Rapid Test
Zalgen ReSARS Pan-Corona Antigen ELISA Kit
Zalgen ReSARS CoV-2 Antigen ELISA Kit
Zhuhai Lituo Biotechnology COVID-19 Antigen Detection Kit
Zhuhai Lituo Biotechnology COVID-19 Antigen Detection Kit

 

FDA Test Authorizations of IVD Products Over Time

There’s been a steady increase in IVD Test Product EUAs over time.? Over a month ago, only the CDC’s own test was available.? Roche’s cobas test approval became the first commercial test, and then many other EUAs followed.

 

Our major global IVD market report for global market estimates in infectious disease testing, molecular diagnostics, oncology testing, hematology, critical care testing and other areas is The Worldwide Market for In Vitro Diagnostic Tests, now in its 13th Edition

 

Significant new EUAs include Roche’s IL-6 Test, Quidel’s Direct Test (no RNA extraction kit required), Abbott’s Alinity m2000?Test, Everlywell’s Home Collection Kit (not a test in the purest sense but regulated by? the FDA as one), Quidel’s Sofia Antigen Test, Sherlock CRISPR test, Biomerieux’s R-GENE 2 triplex PCR test (for covering possible COVID-19 mutations).? ?Bio-Rad’s dPCR test, Roche and Abbott high-throughput Serology tests.

The United States is currently where most COVID-19 testing is occurring, thus tracking the IVD EUA is most important.? ?This chart details FDA Emergency Use Authorization (EUA)s over time.? This chart does not include lab-developed tests (LDT) at universities, hospital medical centers or states that may use the IVD products.

IVD Test Authorizations by Technology Type

RT-PCR is the gold standard and molecular tests are by their nature slightly faster to develop when a virus has a known genetic signature, as is the case with SARS-CoV-2.? Therefore it’s not surprising to see most EUAs? consist of PCR tests, though anti-body tests are increasingly netting authorizations:

 

 

For More Information

N O W? P U B L I S H E D

Kalorama COVID-19 Update: Impact on Molecular Diagnostics, Serology, Critical Care Tests, Vaccines and Telehealth Markets

The current COVID-19 crisis affecting the United States and the world has caused hundreds of thousands of deaths and countless economic costs. This has brought forth an array of solutions that could contribute to detecting, containing and possibly treating the disease. Kalorama Information has covered the fields of molecular diagnostics, vaccines and telehealth for decades. These important industries, already growing in revenues and number of competitors, now find themselves part of the current crisis. Kalorama COVID-19 Update provides trending developments, company announcements and analysis from the Kalorama analysis team on fast-breaking events in the COVID-19 pandemic.

 

 

Early COVID-19 IVD Market Estimates – Moderate Case, Best Case, Worst Case

Molecular Diagnostics

Testing for viruses is normally conducted using RT-PCR, a form of molecular testing. To a lesser degree, antibody tests are used. Both types of testing have been present in the COVID-19 crisis. The report takes a particular interest in molecular diagnostics, the segment in in vitro diagnostics directly affected by COVID-19. Topics explored include the following:

  • Early COVD-19 Related Financial Results at Molecular Test Companies
  • Smaller, Mid-Size MDx Companies See Double Digit Boosts
  • Life Science Company Revenues Down
  • Molecular Testing: A Learning Curve
  • EUA Authorizations
  • Kalorama Survey of Clinical Diagnostic Labs
  • Reopening Plans
  • Supply Issues
  • Marketed Molecular Tests (EUA, CE Other)
  • Potential Market Impact

FOR MORE INFORMATION OR TO ORDER: http://www.5705225.com/product/kalorama-covid-19-update-impact-on-molecular-diagnostics-serology-critical-care-tests-vaccines-and-telehealth-markets/

Antigen and Serology Tests

 

Vaccines, Remote Patient Monitoring and Other Impacted Markets

COVID-19’s influence is being felt across the healthcare spectrum. The report examines the virus’ impact on the vaccines market, non-COVID testing, remote patient monitoring/telehealth and lab automation, including:

  • Select Vaccines in Development for COVID-19
  • Selected Automated Molecular Test Instrument Platforms
  • Non-COVID Testing: Magnitude of Pandemic Impact
  • Remote Patient Monitoring: Companies to Watch

Companies discussed in?Kalorama COVID-19 Update: Impact on Molecular Diagnostics, Serology, Critical Care Tests, Vaccines and Telehealth Markets?include:

  • Abbott
  • AMD Global Telemedicine
  • American Well (Amwell)
  • Becton Dickinson (BD)
  • bioMérieux
  • Bio-Rad
  • BioTelemetry, Inc.
  • Bruker
  • CanSino Biologics
  • Cepheid
  • Doctor on Demand
  • Eko Devices
  • Fluidigm
  • GD (General Devices)
  • GlobalMed
  • Glooko
  • Inovio Pharmaceuticals
  • Masimo
  • MediOrbis
  • Medtronic
  • Meridian Bioscience
  • Moderna
  • Myriad Genetics
  • Natera
  • Qiagen
  • Quidel
  • Rheonix, Inc.
  • Roche
  • SD Biosensor
  • Seegene
  • Teladoc Health
  • Thermo Fisher Scientific
  • Thinklabs
  • Twist Bioscience
  • TytoCare