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. 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 12th Edition.
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.
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:
Authorized Test from Top-Tier IVD Companies
There is a large variety of tests on the market. Major IVD players are involved. Abbott, Roche, Siemens, Thermo Fisher, Bio-Rad and Beckman Coulter are among the top companies in the IVD market, and they have tests in the market, as indicated on the chart below:
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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
In preparing market analysis, Kalorama Information normally consults detailed financial information from major in vitro diagnostics firms to obtain accurate results. In the throes of this crisis such data is lacking. However, using the many statements that have been issued plus knowledge gleaned from our databases on flu and other molecular testing, Kalorama has assembled the following market cases for COVID-19 testing:
- COVID-19 Tests Moderate IVD Market Case (Molecular, Antibody, US/Global)
- COVID-19 Tests Best IVD Market Case (Molecular, Antibody, US/Global)
- COVID-19 Tests Worst IVD Market Case (Molecular, Antibody, US/Global)
In addition, the report features an Appendix that presents the COVID-19 moderate market case analysis in detail (note that the best and worst market cases were built from this moderate case analysis).
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
Serology tests are serum-based immunoassays that are inexpensive and run on high-volume analyzers that are very common in hospital and reference labs, in contrast to PCR tests, which tend to me more complex and expensive. These tests look for the presence of host antibodies that a patient may have developed in reaction to the disease, rather than detecting the disease itself. In so doing, serology tests at some point could ascertain whether patients have immunity, though mechanisms of immunity have not been fully explored with COVID-19. Kalorama COVID-19 Update provides information about serology testing:
- FDA Actions Related to Serology Tests
- Serum/Whole Blood Tests
- Serology Tests on The Market
- Fingerstick Tests
Other IVD Tests
The results of a Kalorama survey on the US Impact on Hospital and Reference Test Volume have pointed toward other in vitro diagnostic testing that may provide useful COVID-19 insights, as well as non-COVID testing issues:
- Critical Care Chemistries
- Blood Gas Testing
- Cardiac Troponin
- AKI Testing
- Other Non-COVID Testing Declines
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:
- AMD Global Telemedicine
- American Well (Amwell)
- Becton Dickinson (BD)
- BioTelemetry, Inc.
- CanSino Biologics
- Doctor on Demand
- Eko Devices
- GD (General Devices)
- Inovio Pharmaceuticals
- Meridian Bioscience
- Myriad Genetics
- Rheonix, Inc.
- SD Biosensor
- Teladoc Health
- Thermo Fisher Scientific
- Twist Bioscience