Description
For years, Kalorama Information has covered the fields of molecular diagnostics, immunoassays, vaccines and telehealth. These all find themselves both sought-after and challenged during the current COVID-19 crisis. This report provides trending developments, company announcements and analysis from the Kalorama analysis team on the fast-breaking events in the COVID-19 epidemic.
Particular sections address the most important market changes:
- Molecular Diagnostics: It’s important to note that the entire molecular testing concept originated in the midst of a crisis, at that time of the AIDS crisis, and has since been brought to bear on a number of emerging and mature infectious disease categories. COVID-19 has seen the molecular in vitro diagnostics (IVD) industry bring out its best efforts in terms of fast test RT-PCR tests for their systems, point of care solutions, syndromic tests, high throughput systems and surge production on badly needed kits.
- Immunoassays: Never have immunoassays been of such worldwide attention, as antibody tests are greatly sought. With this, come concerns about accuracy levels on broad populations and greater knowledge about development times. There are now immunoassays in development. We track these efforts and provide commentary on the role of these tests in a threat so far dominated by molecular diagnostics.
- Vaccines: We look at the vaccines in development and the struggles with vaccine discovery and manufacturing in other pandemics. Companies developing vaccines are featured.
- Other Traditional IVDs: With many hospitals shut down across the globe, what is the impact and expected future of standard in vitro diagnostic testing? – from company statements made both publicly and directly to Kalorama.
- Remote Patient Monitoring: Already a healthcare trend that was catching on but perhaps struggling to convince payors of its critical necessity, remote patient monitoring and telehealth transformed overnight with social distancing policies and relaxed HIPAA rules. But will market players be crowded out by traditional phone and web video companies?
This report does not seek to provide a data-driven market assessment due to the rapidly-changing situation, but does provide analyst commentary that may assist customers needing to work out models. Some of Kalorama Information’s market estimates provide foundational bases on which to judge potential market impact. Commentary and analysis from Kalorama authors who have studied markets in some cases for decades add understanding to the current, often chaotic, market atmosphere. Further publications and surveys from Kalorama Information will provide additional market impact data.
No one company has the solution to COVID-19. Multiple companies have solutions to one problem or part of the solution, and companies are partnering to build strength and distribute products. As part of its coverage, the report mentions the following companies:
- Abbott
- Amaro Lab of the University of California (UC), San Diego
- Avellino Lab USA
- BGI
- BioFire
- Biofourmis
- Boston Scientific
- Bruker
- Cepheid
- Clover
- Credo Diagnostics Biomedical
- Diagnostics for the Real World
- DiaSorin Molecular
- Dynavax
- Emerald Organic
- EpiGentek
- Fluxergy
- GE Healthcare
- Generation Bio
- Genetic Signatures
- GenMark Diagnostics
- Gilead Science
- Green Cross
- Hackensack Meridian Health, Center for Discovery and Innovation’s (CDI)
- Henry Schein
- HiberGene Diagnostics
- Hologic
- JLK Inspection
- Johnson & Johnson (J&J)
- Kleo
- Laboratory Corporation of America (LabCorp)
- Luminex
- Medtronic
- Mesa Biotech
- Mobidiag
- Molbio Diagnostics
- NeuMoDx
- PerkinElmer
- Persivia
- Philips Medical
- Primer Design
- Qiagen
- QuantuMDx
- Quest
- Quidel
- Roche
- Surgisphere
- T2 Biosytems
- Thermo Fisher
- ThermoGenesis
- Todos Medical
- Vir
- Wadsworth Center, New York State Department of Health
- Xencor
Table of Contents
One: SARS-CoV-2 Recent Developments
Molecular Testing, So Far, Remains at Forefront
Antibody SARS-CoV-2 Tests Move Forward
Overall Diagnostics Testing Taking a Hit
When Will Surgeries – and Related Diagnostic Testing – Resume?
Asymptomatic and Presymptomatic Spread Will Focus Attention on Testing
Continuous Introduction and Authorization of New Test Products
- Molecular DX
- Immunoassays
- Spain Provides Example of Downside of Early Serology Test
- Ancillary/Secondary COVID-19-Related Tests
U.S. Government Response
- Congress Passes CARES Act
- HHS Awards $100M to Deal with Coronavirus, including Testing
- BARDA Funding for POC, Panels and Automated Tests
- White House Pushes Diagnostics
- COVID-19 Threat Makes for Odd Timing of VALID Act
Background
- Defining SARS-CoV-2
- Naming the Virus
Origins of SARS-CoV-2
- A Unique Molecular Backbone
FDA Provides Reference Sequence Data for SARS-CoV-2
Countermeasures in Development
Will We See Fundamental Change in IVD?
Two: Molecular Diagnostics and SARS-CoV-2
The Molecular Diagnostics Industry Is Large and Capable
- Rapid Ramp Up After Early Stumbles
Fast EUAs As FDA Moves to Speed Availability of COVID-19 Tests
- Twist’s SARS-CoV-2 Quality Controls Added to FDA Materials
Test Approvals
-
- Table: US FDA EUAs as of April 1, 2020
- Mesa Handheld MDX Test Ships
- Syndromic Approach to COVID-19: Qiagen
- Abbott ID NOW Becomes National Symbol of POC Response
- Luminex Coronavirus Panel Gets FDA Emergency Authorization
- BGI Gets EUA for RT-PCR Coronavirus Test
- Quidel Receives Expanded Approval
- NeuMoDx Coronavirus Test Gets Emergency Authorization
- T2 Adds Coronavirus Test to Panels, per Health Network Deal
- PerkinElmer Gets Regulatory Nod in U.S. for Coronavirus Test
- Roche Offers Multiple Commercial Kits
- Thermo Fisher gets CE Mark for the TaqPath COVID-19 RT-PCR Test Kit
- Mesa Biotech Gets Emergency Authorization for POC Coronavirus Test
- Fluxergy Seeks Emergency Authorization for 1-Hour Coronavirus Test
- Genetic Signatures Seeks CE Mark for Coronavirus Diagnostic
- Emerald Organic, Todos Medical Team on COVID-19 Tests
- Bruker, Primer Design Sign European Distribution Deal for Coronavirus Test
Impact of Large Systems and Small POC Systems
Molecular Point of Care
- Molecular POC vs. Immunoassays
Three: Bottlenecks
Practical Challenges and Scaling of Test Resources
Test Equipment and Worker PPE Remain an Issue
- JAMA Network Calls for Creative ideas for Increasing PPE Supply
- Why SARS 2.0 Is More Difficult to Control
- Table: COVID-19 Case Severity Scale
SARS-CoV-2 Replication in Upper Respiratory Track Seen as Culprit
HAIs a Worry
Are Coronavirus Patients with Negative Throat Swabs Truly Virus-Free?
Patients May Continue to Shed Virus After Symptom Clearance
Viral Load/ Symptom Connection: Conflicting Studies
mPOC s Are Approved; Full Impact Yet to Be Seen
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- Figure: FDA EUA Tests for COVID-19 by Testing Type
Qiagen says it Ramped Up Production to Meet Shortage of RNA Extraction Kits
Four: COVID-19 Immunoassays
Antibody-Based Testing Taking Shape
- Policy D Pathway
- Cellex Approval
- BioMedomics
- Getting Better Guidance on Test Quality
- Serology Test Notifications
Five: Other Test Categories Impact: Critical Care, Chemistries
Critical Care Analysis
- Blood Gas
- Critical Care Analytes: Bilirubin, BUN, glucose
Other COVID-19-Related Tests
Six: Vaccines and SARS-CoV-2
Early Efforts and a First Trial Dose
- J&J Seeks to Release COVID-19 Vaccine by 2021
- DOD Grant Accelerates SARS-CoV-2 Vaccine Manufacturing
- Dynavax, Clover Partner for Protein-based COVID-19 Vaccine
Kalorama Analysts: Technology, Not Demand Challenge
Production Consideration
3D Atomic Scale Map Could Aid Vaccines
Seven: Boost for Remote Patient Monitoring Seen in SARS-Cov-2 Crisis
Congressional Action
HIPPA Penalties Relaxed
Unique Opportunities in Telehealth/Telemedicine
Companies in the Market
Recent Developments
Eight: A Role for Artificial Intelligence (AI)
Introduction
- White House Urges Researchers to Use AI to Analyze Coronavirus Papers
Diagnostic Applications
- South Korean Firm Blends AI and Portable X-Ray Testing to Power Up COVID-19 PCR
- Persivia Releases AI-driven Ruleset to Detect COVID-19
- Philips IntelliSite Pathology Solution
- Surgisphere Rapid Test Uses AI to Diagnose COVID-19
- Biofourmis’ AI-Powered Remote Monitoring Platform to Fight COVID-19
AI as an Aid in the Development of COVID-19 Therapies
Nine: Therapeutics and COVID-19
FDA’s Coronavirus Treatment Acceleration Program (CTAP)
- Snapshot for Developing Therapeutics
- Examples of CTAP in Action
- Support for CTAP
Selected Therapeutic Approaches
- Drug Repurposing
- CAR-T Support Therapeutic Finds Possible Use in COVID-19
- Kleo, Green Cross Collaborate on COVID-19 NK Combination Therapy
- Generation Bio, Vir Partner for mAbs against COVID-19
- Xencor, Vir Partner on COVID-19 Antibodies Research
- Frontera Supercomputer Aids COVID-19 Drug Development
- Hydroxychloroquine
Ten: Respiratory Equipment in Extreme Demand
Ventilators
CPAP Devices and COVID-19 Patient Usage
- CPAP as an Emergency Ventilator?
- Risk of Virus Spread and Possible Solutions
Pulse Oximeters
Recent EU Activity
Cares Act
Defense Production Act
Eleven: Research Laboratory Operations Impacted
NIH Shifts Noncritical Research to Maintenance
Survey: Nearly Half of All Life Science Labs around the World Are Currently Closed
Survey: COVID-19 Causes Long-Term Disruptions to Clinical Trials
