TestingCommons.com
COVID Diagnostics:
The Beginning, Middle and End of the Pandemic 2022: The Year of The Test
TestingCommons.com A one-stop reliable source for comprehensive information about COVID-19 tests worldwide. Search all tests in the market and in the pipeline by multiple parameters including test type, technology, regulatory status, country of origin and more. TestingCommons.com, part of COVID Diagnostics Commons initiative, at Arizona State University’s College of Health Solutions Testing Commons is made possible with support from The Rockefeller Foundation 2
TestingCommons.com 2021 Summary • Total EUA activity • 133 EUA’s in 2021 vs. 188 EUA’s in 2020 Schedule IV
EUA
EUA
• Antigen Rapid Self-Test EUA activity • 2021 Q1 through Q3 – 6 new EUA’s • 2021 Q4 – 6 new EUA’s (ACON, Celltrion, InBios, iHealth, SD BioSensor (Roche), Siemens)
• Molecular EUA activity • 2021 3 Rapid Molecular [Cue in Q1, Lucira in Q2, Detect in Q4] • 2021 Lab Based Molecular – 43 new EUAs [for COVID assays, excludes multi-analyte panels and collection kits] Questions: mara.aspinall@asu.edu
TestingCommons.com Pandemic Review
Molecular, Antigen, Serology, & T-Cell Tests, Patient Management, Combination Respiratory Panels and Collection Kits
FDA EUA LDT
Schedule IV
EUA EUA
Schedule IV notifications & Umbrella Molecular EUAs1 EU self-certification
CE-IVD Research Use Only
In US: not for clinical use. Outside US: commercially available Tests & Technologies publicly announced to be under development
Development FDA Revoked
Revoked, Rejected, Withdrawn, Warning letter, Fraud (DOJ) 0
200
400
600
1. Discontinued after 10/7/20 when HHS/FDA announced policy to not require authorization for COVID LDT
800
1000
1200
Questions: mara.aspinall@asu.edu
Pandemic Total through 12/31/21
US FDA EUA Test Classifications • Tests: • • • •
Molecular Tests (including Appendix A LDTs and Flu panels) Antigen Tests (including Flu panels) Patient Management Tests (IL6) Serology (Antibody) Tests (including cellular immunity)
• Collection Kits
• Home Collection Kits (Nasal Swabs or Saliva)
• Test Attributes: • • • • •
Test Location (Lab vs. POC vs. Home) Screening (Asymptomatic) Serial Screening Pooling OTC vs Prescription
US FDA Emergency Use Authorizations
250
Molecular
Number of Tests
200
150
Antibody
100
Other
Antigen
50
0
Molecular 88% RTqPCR 9% Isothermal 2% Sequencing 1% CRISPR
Antigen 92% Lateral Flow 8% other
Antibody 62% ELISA 35% Lateral Flow 3% Other
Other Collection Kits Flu/RSV Panels Patient Management
Pandemic Total through 12/31/21
Profile of US FDA EUA’s Lab Authorized to Analyze Sample
300
# Tests
250 200
CLIA High Complexity Lab
150 100 50
CLIA Moderate Complexity Lab
CLIA Waived / Point of Care Lab
Self Test (No Lab Required)
0 350 300
Swab
Sample Type
Collected1
300 250
# Tests
# Tests
250 200 150 100 50 0
Person to Collect Sample2
Saliva
Venous Blood
Fingerstick Blood
200 150 100 50 0
Health care or Trained Tech
Self Collect
Pandemic Total through 12/31/21
1. Only a single Swab type per test counted here, in least to most invasive priority order: Saliva; ANS; lastly NPS/OPS. All PCR tests are sensitive enough to work with nearly all of these swab types: later authorizations specify ANS in addition to other swab methods. 2. No specific Healthcare Professional training is required by the EUA (at Laboratory discretion)
16 EUA’s for OTC Self Tests MOLECULAR TESTS (3)
OTC TESTS (16)
• • • Cue for Home & OTC: • SINGLE • • • • Detect At-Home: SINGLE Sympt + • Serial Asymptomatic • • • Lucira CHECK-IT Test: • SINGLE • • • New Q4*
ANTIGEN TESTS (13)
Abbott BinaxNOW Card 2 Home: Serial: Asympt. & Single: Sympto Abbott BinaxNOW Ag Self: Serial: Asympt. & Single: Sympto Access Bio CareStart Home: Serial: Asympt. & Single: Sympto ACON Flowflex: Single for both: Asymptomatic and Sympto BD Veritor At-Home: Serial: Asympt. & Single: Sympto Celltrion At Home: Serial: Asympt. & Single: Sympto Ellume COVID-19 Home: Single for both: Asymptomatic and Sympto iHealth COVID-19 Home: Serial: Asympt. & Single: Sympto InBios Int’l Detect Self: Serial: Asympt. & Single: Sympto OraSure InteliSwab Rapid: Serial: Asympt. & Single: Sympto Quidel QuickVue At-Home: Serial: Asympt. & Single: Sympto Roche / SDBiosensor At-Home: Serial: Asympt. & Single: Sympto Siemens CLINITEST: Serial: Asympt. & Single: Sympto Pandemic Total through 12/31/21
43 Antigen Tests with EUAs CLIA High/Moderate (Lab)
Instrument read
Celltrion Sampinute DiaSorin LIAISON Ortho VITROS Qorvo Omnia QIAGEN QIAreach Quanterix Simoa
Visual read
New Q4*
CLIA Waived. (MD Office)
Home
BD Veritor BD Veritor + Flu A/B Ellume Luminostics Clip LumiraDx Quidel Sofia FIA Quidel Sofia2+Flu
BD Veritor Ellume OTC
Access Bio CareStart ANP Technologies NIDS BinaxNOW Card BinaxNOW 2 Card Celltrion DiaTrust GenBody COVID-19 Ag InBios SCoV-2 Nano-Ditech Nano-Check* OraSure Inteliswab Pro PHASE Scientific INDICAID Princeton Status+Flu Salofa Sienna-Clarity Quidel QuickVue Xtrava Health SPERA*
Access Bio CareStart ACON Flowflex* BinaxNOW Home Rx BinaxNOW Self OTC BinaxNOW Telehealth Celltrion DiaTrust* iHealth Rapid OTC* InBios CoV-2 Self* OraSure Inteliswab RX OraSure Inteliswab OTC Quidel QuickVue Rx Quidel QuickVue OTC Roche/SD Biosensor* Siemens CLINITEST*
Pandemic Total through 12/31/21
24 EUA’s for Respiratory Panels (Flu, RSV, etc.) 25
Number of Tests
20
15
10
5
0
Molecular (18) 80% Lab 20% POC
Antigen (3) 100% POC
Collection Kit (1) 100% Molecular Pandemic Total through 12/31/21
CE-IVD Certified Tests (Mostly Europe) Antigen
450
Antibody
400
Number of Tests
350 300
Molecular
250 200 150
Other
100 50 0
Molecular 91% RTqPCR 6% Isothermal 3% Other
Antigen 62% Lateral Flow 5% ELISA 33% Other
Antibody 37% Lateral Flow 46% ELISA 17 % Other
Other Collection Kits Flu/RSV Panels Pandemic Total through 12/31/21
Tests in Development Worldwide 120
Molecular
Number of Tests
100
Antigen
80
Antibody
60 40
Other
20 0
Molecular 40% RTqPCR 24% Isothermal 15% CRISPR 13% Sequencing 9% Other
Antigen 59% Lateral Flow 19% ELISA 9% Breath 13% Other
Antibody 61% Lateral Flow 30% ELISA 9% Other
Other Breath / VOC Mass Spec Raman Spec Pandemic Total through 12/31/21
Companies with the largest number of EUAs 12
12 11
10
Number of Tests
Pandemic Total through 12/31/21
10
8
8
8 7
6
6
6 5
4
5
5
Diasorin
Access Bio
2 0
Abbott
Siemens
Roche
Danaher*
Quidel
Thermo BD Quest Color Health Fisher 4 Molecular 1 Molecular 7 Molecular 4 Molecular 3 Molecular 6 Molecular 2 Molecular 5 Molecular 5 Molecular 1 Antigen 3 Antibody 5 Antigen 5 Antigen 1 Antigen 1 Antibody 3 Antigen 1 Collection 3 Antibody 8 Antibody 2 Antibody 1 Pt Mgmt 1 Pt Mgmt Kit 1 Pt Mgmt *Cepheid + Beckman Coulter
1 Molecular 1 Molecular 1 Antigen 2 Antigen 13 3 Antibody 2 Antibody
FDA Revoked EUA’s & Other Safety Communications Letters to Healthcare Providers (15) Safety Communications (9)
•
Safety Communications: FDA posts Medical Device Safety Communications to describe FDA’s analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.
•
Letters to Healthcare Providers: FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.
Revoked Antigen EUA (5) Revoked Molecular EUA (15)
Revoked Antibody EUA (171)
Pandemic Total through 12/31/21
Other FDA Safety Communications by Subject
Warning Letters to Ancillary Companies - Blue Willow Biologics - Invisi Smart Technologies - Jordan’s Crossing Herbal Connections - Kaleido Biosciences, Inc. - Mahita, LLC dba PushMyCart - Rxmedcart.com - Shanghai Dasheng
Letters to Health Care Providers - BD Max - ThermoFisher - Roche
Safety Communications - Abbott - Curative - Ellume - Innova - Leccurate - Lepu Medical - Quidel
Letters to Health Care Providers - Antibody Testing (2) - Transport Media - Self Testing / Nasal Swabs - Rapid Antigen Tests - Variants
Safety Communications - Antibody Testing - Veterinary Ivermectin
Pandemic Total through 12/31/21
EUA’s for Asymptomatic Screening & Serial Screening
*3 saliva
Collection Kit, 10 Molecular Home, 2
Antigen Home, 2 Antigen POC, 1
Serial Testing – 2 tests in 24-48 hours
Antigen Home, 11
*4 saliva Molecular POC, 38
Antigen POC, 12
*1 saliva
Screening (53)
Molecular POC, 9
Serial Screening (32)
Pandemic Total through 12/31/21
24 EUA’s for Respiratory Panels (Flu, RSV, etc.) Molecular Respiratory Combination Tests (20) • • • • • • • • • • • • • • • • • • • •
Abbott Alinity m Resp-4-Plex Applied BioCode CoV-Flu Plus Assay* BD for BD MAX system BioFire Diagnostics Respiratory Panel 2.1 EZ Bio-Rad Reliance CDC Flu C2 Multiplex Assay Cepheid Xpert Xpress Ful/RSV Cepheid Xpert Xpress Flu/RSV Plus Exact Science Laboratories COVID-Flu Multiplex GenMark ePlex Respiratory Pathogen Panel 2 Hologic Aptima Labcorp SARS-CoV-2 & Influenza A/B Assay Luminex NxTAG Respiratory Pathogen Panel + SARS-CoV-2 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay PerkinElmer Pkamp Respiratory SARS-CoV-2 Panel 1* QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel Quest RC COVID-19+Flu RT-PCR Roche cobas Roche cobas for use with Liat system Thermo Fisher TaqPath
New Q4*
Antigen Respiratory Combination Tests (3) • BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B • Princeton BioMeditech Corp. Status COVID-19/Flu • Quidel Sofia 2 Flu + SARS Antigen FIA Molecular Respiratory Combination Collection Kits (1) • Everlywell COVID-19 & Flu Test Home Collection Kit
Pandemic Total through 12/31/21
36 EUA’s for Testing of Pooled Samples
POOL SIZE
CDC [RT-PCR Diagnostic Panel] Quest [SARSCoV-2 rRT-PCR]
• •
Quest [RC SARSCoV-2 Assay] Roche [cobas SARS-CoV-2]
• •
2 (1 Test) 4 (2 Tests) 5 (22 Tests) 6 (2 Tests) 7 (1 Test) BayCare [SARSCoV-2 RT PCR Assay]
BioFire [COVID-19 Test] Cepheid [Xpert Xpress SARS-CoV-2]
8 (2 Tests) 10 (4 Tests) 12 (2 Tests)
Poplar [TMA Pooling assay]
• Abbott [Alinity m SARS-CoV-2 assay] • OPTI SARS-CoV-2 RT-PCR Test • Amazon/STS Labs HoldCo [4 assays] • PerkinElmer [New COVID Nucleic Acid Detection • Applied BioCode [ SARS-CoV-2 Assay] Kit] • Enzo [AMPIPROBE SARS-CoV-2 Test System] • SML GENETREE [Ezplex SARS-CoV-2 G Kit] • Hologic [Aptima SARS-CoV-2 assay] • Thermo Fisher TaqPath • Hologic [Panther Fusion SARS-CoV-2 Assay] • UCSD [RC SARS-CoV-2 Assay] • Infinity BiologiX TaqPath SARS-CoV-2 Assay • Visby Medical COVID-19 • Labcorp [COVID-19 RT-PCR Test] • Yale School of Public Health SalivaDirect • Labcorp [Pixel Home Collection Kit] • Yale SalivaDirect for use with DTC Kits • LetsGetChecked Coronavirus (COVID-19) Test • LumiraDx [SARS-CoV-2 RNA STAR Complete]
• • • Broad Institute CRSP rtPCR Assay (Version 3) • Viracor Eurofins [SARS-CoV-2 assay] • Clinical Enterprise SARS-CoV-2 RT-PCR Assay • Biomeme SARS-CoV-2 RealTime RT-PCR Test
Quadrant Biosciences [Clarifi COVID-19 Test Kit] Verily [COVID-19 RTPCR Test]
Pandemic Total through 12/31/21
21 EUA’s for Independent Home Specimen Collection Kits Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA’s
16 14
Number of Tests
12 10 8 6 4 2 0
Swab (14) 64% Rx 36% DTC
Rx: requires prescription DTC: direct to consumer
Saliva (7) 57% Rx 43% DTC
Pandemic Total through 12/31/21
21 EUA’s for Independent Home Specimen Collection Kits Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA’s
Swab Collection Kits (14)
• Audere HealthPulse@home* • binx health At-Home Nasal Swab COVID-19 Sample Collection Kit • Clinical Enterprises EmpowerDX COVID-19 Home Collection Kit DTC • Color COVID-19 Self-Swab Collection Kit • Color COVID-19 Self-Swab Collection Kit DTC • Color COVID-19 Self-Swab Collection Kit with Saline • Everlywell COVID-19 Test Home Collection Kit • Everlywell COVID-19 Test Home Collection Kit DTC • Everlywell COVID-19 & Flu Test Home Collection Kit • GetMyDNA COVID-19 Test Home Collection Kit • Kroger Health COVID-19 Test Home Collection Kit • Kwokman Diagnostics COVID-19 Home Collection Kit • Quest Diagnostics Collection Kit for COVID-19* • RapidRona Self-Collection Kit
New Q4*
Saliva Collection Kits (7)
• DNA GenoTech OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) Saliva Collection Device • DNA GenoTech ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 Saliva Collection Device • Phosphorus Diagnostics LLC Pinpoint by Phosphorus COVID19 Test Home Collection Kit DTC • Spectrum Solutions SDNA-1000 Saliva Collection Device • WREN Laboratories COVID-19 Saliva Test Collection Kit DTC • Yale School of Public Health SalivaDirect • Yale School of Public Health SalivaDirect DTC
Pandemic Total through 12/31/21
Research Use Only Tests 250
Molecular
Antibody
Number of Tests
200
150
100
Antigen
Other
50
0
Molecular 88% RTqPCR 9% Isothermal 2% Other
Antigen 67% Lateral Flow 33% ELISA
Antibody 48% Lateral Flow 52% ELISA
Other Collection Kits Flu/RSV Panels Pandemic Total through 12/31/21
EUA’s for Management of COVID-19 Patients IVDs for Management of COVID-19 Patients (4) - Roche Diagnostics Elecsys IL-6
(June 2020)
- Beckman Coulter, Inc. Access IL-6
(October 2020)
- Siemens Healthcare Diagnostics Inc. ADVIA Centaur IL6 Assay
(December 2020)
- BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site)
(August 2021)
Pandemic Total through 12/31/21
New EUAs by Technology Q4 2021 (n=19) Total Q4 2021 New EUA’s 5 1
2
Comprehensive At-Home Tests Flu / RSV Combo Tests Lab / POC COVID only
4 3
Molecular Tests
Antigen Tests
2
2
Serology Tests
Collection Kits
New EUAs by Technology Q3 2021 (n=28) 0
3
Total Q3 2021 New EUA’s
10 Comprehensive At-Home Tests Flu / RSV Combo Tests 2
5
Lab / POC COVID only 5 3
Molecular Tests
Antigen Tests
Serology Tests
Collection Kits
New EUAs by Technology Q2 2021 (n=45) 1
Total Q2 2021 New EUA’s
6
Comprehensive At-Home Tests
15
Flu / RSV Combo Tests Lab / POC COVID only
2
8
9
5
Molecular Tests
Antigen Tests
Serology Tests
Collection Kits
New EUAs by Technology Q1 2021 (n=41)
1
Total Q1 2021 New EUA’s
6
Comprehensive At-Home Tests Flu / RSV Combo Tests
14
Lab / POC COVID only 10 3 1
3 Molecular Tests
Antigen Tests
Collection Kits are listed separately as their own category by Testing Commons
3 Serology Tests
Collection Kits
Timeline of EUA Issuances and Amendments by Type 1
1
2
4
3
3
1
2
1 3
2 6
7 5
2
1
4 1
2
1
1
2
2 2
9 4
8
13
25
9 6
32 1
17
1
5 8 3
3
1
2
4
3 4
5 5
14
2
3
2
8
1
1
1
2 2
4
3 3
28
20
19
21 2
8
8
Antibody
6
1
5
28
6
Antigen
4
6
6
Molecular
1 12
10
8
3
2
Flu/RSV
Collection Kit
1
Pandemic Total through 12/31/21
COVID-19 Diagnostics Related Legal Issues • Federal (U.S.)
• Regulatory – late 2021 – HHS/FDA make changes to EUA process for LDTs • Fraud / SEC violations – Early stage Dx companies running into billing / operations legal trouble • IP – NIH – Moderna disputing inventorship of vaccine patents • USPTO has issued approximately 130 COVID-19 diagnostic patents
• U.S. Supreme Court legal battle over OSHA vaccine-or-test federal mandate for private employers • ADA – fight over whether long-haul COVID-19 is a disability under ADA
• International
• Waiver of patent rights on an international scale • U.S. supports but has not yet waived rights • Currently contemplated for vaccine patents, but could be extended to Diagnostics
Acknowledgements I would like to thank the following people & organizations for their help and support: • ASU College of Health Solutions • Sarah Igoe, M.D. for her leadership on TestingCommons.com • Nate Wade, Ph.D., for his brilliant work and partnership as Co-PI • Michael Donovan, J.D., Ph.D. • Dean Deborah Helitzer, Sc.D. • ASU Decision Theater • The entire Decision Theater team including Sri Kandala, Ph.D. and Fangwu Wei, Ph.D. • The Rockefeller Foundation • For the enabling grant for TestingCommons.com and continued commitment to diagnostics education • Special thanks to Leah Perkinson Mara G. Aspinall – mara.aspinall@asu.edu Professor of Practice, Biomedical Diagnostics, College of Health Solutions, Arizona State University Advisor, The Rockefeller Foundation