2022 Observations and Takeaways
Based on the information aggregated on TestingCommons.com, we’ve seen the following trends in 2022:
• Decline in COVID EUA Activity | 2022 saw another dramatic decline in new EUA approvals
• 47 in 2022, 134 in 2021, and 233 is 2020
EUA EUA Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
• Transition Away from Lab-based to Self Tests | 2022 confirmed the transition away from lab-based tests to OTC / Self Tests as well as away from the more invasive nasopharyngeal swabs to anterior nasal swabs. The focus also pivoted away from pooled specimen tests with no new EUA’s for pooling in 2022.
• New Test Categories | The FDA added two new categories for unique tests in 2022 – but issued only one EUA in each category: one for a Point of Care breath analysis test and one for a Lab-based test for genotypic lineage identification.
• Increased Quality Focus | The FDA also dedicated much focus in 2022 to quality control: they issued 32 warning letters to companies making false COVID -related claims, and they revoked 20 EUAs including PCR assays to reagents, antibody tests, and OTC antigen tests.
EUA Issuances Annually through 2022 155 46 24 11 28 18 58 25 3 8 18 9 17 2 0 50 100 150 200 2020 2021 2022 Collection Kit Flu/RSV Antibody Antigen Molecular Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu Total: 47 Total: 134 Total: 241
US FDA Emergency Use Authorizations 0 50 100 150 200 250 Molecular 86% RTqPCR 10% Isothermal 2.5% Sequencing 0.5% CRISPR Antigen 93% Lateral Flow 7% other Antibody 63% ELISA 34% Lateral Flow 3% Other Other Collection Kits Flu/RSV Panels Patient Management Molecular Antigen Antibody Other Number of Tests Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu Molecular 225 57 86 54
EUA Issuances and Amendments by Type by Year Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu 338 168 138 14 44 92 107 59 29 12 21 22 13 21 12 2020 (Apr-Dec) 2021 2022 Molecular Antigen Antibody Flu/RSV Collection Kit EUA’s: 47 Amendments: 246 Total - 293 EUA’s: 134 Amendments: 179 Total – 313 EUA’s: 241 Amendments: 243 Total – 484
Profile of US FDA EUAs Health care or Trained Tech 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) Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu SWAB SALIVA VENOUS BLOOD FINGERTIP BLOOD BREATH 336 44 67 11 1 Sample Type Collected1 Lab Authorized to Analyze Sample CLIA LAB High Complexity CLIA LAB Moderate Complexity CLIA Waived / Point of Care Self Test / No Lab
TestingCommons.com Pandemic Review 0 200 400 600 800 1000 1200 1400 FDA Revoked Development Research Use Only CE-IVD LDT FDA EUA Schedule IV notifications & Umbrella Molecular EUAs1 In US: not for clinical use. Outside US: commercially available Tests & Technologies publicly announced to be under development Revoked, Rejected, Withdrawn, Warning letter, Fraud (DOJ) Molecular, Antigen, Serology, & T-Cell Tests, Patient Management, Combination Respiratory Panels and Collection Kits EU self-certification 1. Discontinued after 10/7/20 when HHS/FDA announced policy to not require authorization for COVID LDT Schedule IV EUA EUA Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
30 EUAs for OTC Self Tests • Aptitude Metrix COVID-19 • Cue OTC • Detect At-Home • Lucira CHECK-IT • Abbott BinaxNOW Card 2 Home • Abbott BinaxNOW Ag Self • Access Bio CareStart Home • ACON Flowflex • Advin Test @ Home* • ANP Technologies NIDS* • Azure Biotech Fastep* • BD Veritor At-Home • Beijing Hotgen* • Celltrion At Home • CorDxm Ag Test* • CTK Biotech ImmuView* • Ellume COVID-19 Home ANTIGEN TESTS (26) MOLECULAR TESTS (4) New 2022 Q4* • Genabio Rapid Self-Test • iHealth COVID-19 Home • InBios Int’l Detect Self • MaximBio ClearDetect • Oceanit ASSURE-100* • OraSure InteliSwab Rapid • OSANG OHC Self-Test • PHASE INDICAID At-Home • Quidel QuickVue At-Home • Roche / SDBiosensor At-Home • Siemens CLINITEST • Watmind SpeedySwab • Xiamen Boson Rapid Ag Card* Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
Access Bio CareStart Acon Flowflex Rapid Test* ANP Technologies NIDS BinaxNOW Card BinaxNOW 2 Card Celltrion DiaTrust GenBody COVID-19 Ag InBios SCoV-2 Nano-Ditech Nano-Check Oceanit ASSURE-100 OraSure Inteliswab Pro PHASE Scientific INDICAID Princeton Status+Flu Salofa Sienna-Clarity Quidel QuickVue Xtrava Health SPERA 59 Antigen Tests with EUAs Instrument read Visual read CLIA High/Moderate (Lab) CLIA Waived (MD Office) Self Tests Celltrion Sampinute DiaSorin LIAISON Ortho VITROS Qorvo Omnia QIAGEN QIAreach Quanterix Simoa Siemens ADVIA Siemens Atellica BD Veritor Ellume OTC BD Veritor BD Veritor + Flu A/B Ellume Luminostics Clip LumiraDx Quidel Sofia FIA Quidel Sofia2+Flu New 2022 Q4* Pandemic Total through 12/31/22 Abbott BinaxNOW Card 2 Home Abbott BinaxNOW Ag Self Access Bio CareStart Home ACON Flowflex Advin Test @ Home* ANP Technologies NIDS* Azure Biotech Fastep* BD Veritor At-Home Beijing Hotgen* Celltrion At Home CorDxm Ag Test* CTK Biotech ImmuView* Ellume COVID-19 Home Genabio Rapid Self-Test iHealth COVID-19 Home InBios Int’l Detect Self MaximBio ClearDetect Oceanit ASSURE-100* OraSure InteliSwab Rapid OSANG OHC Self-Test PHASE INDICAID At-Home Quidel QuickVue At-Home Roche / SDBiosensor At-Home Siemens CLINITEST Watmind SpeedySwab Xiamen Boson Rapid Ag Card*
30 EUAs for Respiratory Panels (Flu, RSV, etc.) 0 5 10 15 20 25 30 Molecular (26) 77% Lab 23% POC Antigen (3) 100% POC Number of Tests Collection Kit (1) 100% Molecular Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
• 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
• Cleveland Clinic SelfCheck cobas*
• Exact Science Laboratories COVID-Flu Multiplex
• GenMark ePlex Respiratory Pathogen Panel 2
• Hologic Aptima
• Labcorp SARS-CoV-2 & Influenza A/B Assay
• Labcorp Seasonal Respiratory Virus RT-PCR *
• Labcorp Seasonal Respiratory Virus RT-PCR DTC*
• Lucira Health COVID-19 & Flu Test*
• Luminex NxTAG Respiratory Pathogen Panel + SARS-CoV-2
• NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
• Opti Medical Systems*
• 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
• Visby Medical Respiratory Health Test*
Respiratory Combination Tests (26)
Molecular
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 30 EUAs for Respiratory Panels (Flu, RSV, etc.) New 2022* Molecular Respiratory Combination Collection Kits (1) • Everlywell COVID-19 & Flu Test Home Collection Kit Pandemic Total through 12/31/22
41 EUAs for Testing of Pooled Samples • Abbott [Alinity m SARS-CoV-2 assay] • Amazon/STS Labs HoldCo [4 assays] • Applied BioCode [ SARS-CoV-2 Assay] • DC Dept of Health [Test Yourself DC At-Home] • Enzo [AMPIPROBE SARS-CoV-2 Test System] • Hologic [Aptima SARS-CoV-2 assay] • Hologic [Panther Fusion SARS-CoV-2 Assay] • Infinity BiologiX TaqPath SARS-CoV-2 Assay • Labcorp [COVID-19 RT-PCR Test] • Labcorp [Pixel Home Collection Kit] • LetsGetChecked Coronavirus (COVID-19) Test • LumiraDx [SARS-CoV-2 RNA STAR Complete] • OPTI SARS-CoV-2 RT-PCR Test • PerkinElmer [New COVID Nucleic Acid Detection Kit] • Quest [PF SARS-CoV-2 Assay] [COVID-19 PCR DTC] • SML GENETREE [Ezplex SARS-CoV-2 G Kit] • Thermo Fisher TaqPath • UCSD [RC SARS-CoV-2 Assay] • Visby Medical COVID-19 • Yale School of Public Health SalivaDirect • Yale [SalivaDirect] [ SalivaDirect for use with DTC Kits] • Quest [RC SARSCoV-2 Assay] • Roche [cobas SARS-CoV-2] • BioFire [COVID-19 Test] • Cepheid [Xpert Xpress SARSCoV-2] • Predicine [SARS-CoV-2 RTPCR Test] • CDC [RT-PCR Diagnostic Panel] • Quest [SARS-CoV-2 rRT-PCR] • BayCare [SARSCoV-2 RT PCR Assay] • Poplar [TMA Pooling assay] • Quadrant Biosciences [Clarifi COVID-19 Test Kit] • Verily [COVID-19 RTPCR Test] POOL SIZE 2 (1 Test) 4 (2 Tests) 5 (26 Tests) 6 (2 Tests) 7 (1 Test) 8 (3 Tests) 12 (2 Tests) • 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 10 (4 Tests) 3 (1 Test) Vela Operations [ViroKey PCR] Pandemic Total through 12/31/22
0 5 10 15 20 25 9 Rx 4 Rx Swab (16) Saliva (7) 23 EUAs for Independent Home Specimen Collection Kits Number of Tests Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA’s Rx: requires prescription OTC: Over the Counter / Direct to Consumer Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu 7 OTC 3 OTC
Swab Collection Kits (16) • Audere HealthPulse@home • Audere HealthPulse@home Fusion • 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 • Quest COVID-19 PCR Test Home Collection Kit • RapidRona Self-Collection Kit Saliva Collection Kits (7) • DNA Genotek OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) Saliva Collection Device • DNA Genotek 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 23 EUAs for Independent Home Specimen Collection Kits Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA’s Pandemic Total through 12/31/22
CE-IVD Certified Tests (Mostly Europe) 0 50 100 150 200 250 300 350 400 450 500 Molecular 86% RTqPCR 6% Isothermal 8% Other Antigen 56% Lateral Flow 5% ELISA 39% Other Antibody 36% Lateral Flow 45% ELISA 18 % Other Number of Tests Other Collection Kits Flu/RSV Panels Breath/VOC Molecular Antigen Antibody Other Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
Research Use Only Tests 0 50 100 150 200 250 Molecular 88% RTqPCR 9% Isothermal 2% Other Antigen 68% Lateral Flow 32% ELISA Antibody 48% Lateral Flow 52% ELISA Num b er of Tests Other Collection Kits Flu/RSV Panels Molecular Antigen Antibody Other Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
0 20 40 60 80 100 120 Molecular 40% RTqPCR 22% Isothermal 14% CRISPR 12% Sequencing 10% Other Antigen 49% Lateral Flow 11% ELISA 6% Breath 34% Other Antibody 62% Lateral Flow 30% ELISA 8% Other Number of Tests Other Breath / VOC Mass Spec Raman Spec Molecular Antigen Antibody Other Tests in Development Worldwide Antigen Pandemic Total through 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
Companies with the Largest Number of EUAs 13 12 11 11 9 8 7 7 6 5 5 5 0 2 4 6 8 10 12 Siemens Abbott Roche Quest Danaher* Quidel Thermo Fisher InBios Int'l BD Color Health Access Bio LabCorp 18 Number of Tests 5 Molecular 4 Antigen 3 Antibody 1 Molecular 3 Antigen 8 Antibody 1 Pt Mgmt 3 Molecular 5 Antigen 7 Molecular 1 Antigen 2 Antibody 1 Pt Mgmt 8 Molecular 2 Collection Kits 1 Flu/RSV 2 Molecular 3 Antigen 1 Pt Mgmt 2 Molecular 3 Collection Kits 5 Molecular 6 Molecular 1 Antibody 5 Molecular 3 Antibody 1 Pt Mgmt *Cepheid + Beckman Coulter 1 Molecular 2 Antigen 2 Antibody 1 Molecular 2 Antigen 4 Antibody Pandemic Total through 12/31/22
• Warning Letters: FDA identifies significant violations of regulations and notifies manufacturer
• 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 EUAs & Other Safety Communications
FDA
Revoked Molecular EUA (28) Revoked Antigen EUA (7) Revoked Antibody EUA (175) Safety Communications (18) Letters to Healthcare Providers (15) Warning Letters (43) Pandemic Total through 12/31/22
Warning Letters (43)
- Blue Willow Biologics
- Invisi Smart Technologies
- Jordan’s Crossing Herbal
Connections
- Kaleido Biosciences, Inc.
- Mahita, LLC dba PushMyCart
- Rxmedcart.com
- Shanghai Dasheng - Varigard, LLC
- Amcyte Pharma, Inc.
- Genesis Partnership Co SA
- CES LLC
- Frozen Wheels, LLC
- Avila Herbals, LLC
- Glenn Burkett Naples Corporation
- Pharmacy2Home/LandiCom
Holding - Extrapharmacy.ru
- Rxshopmd.com
- CytoDyn, Inc
- My Natural Treatment
- Lusys Laboratories, Inc
- Bea Lydecker's Naturals, Inc.
- Viraldine, LLC
- Soda Pharm - Ivermectin24h.com
- Iotech International LLC
Letters to Healthcare Providers (15)
Applied Biological Laboratories, - Iodine Products I
- Agropharma Laboratories, Inc.
- Heaven's Organic LLC - UPSY LLC
- Nature's Highway - Functional Remedies, LLC D/B/A Synchronicity Hemp Oil
- CBD Social - Heaven's Organic LLC - UPSY LLC - Sensory Cloud, Inc - CoFixRx, LLC
- Santhigram Kerala Ayurvedic US.
- Haniel Concepts, Inc. DBA Free State Oils, LLC - FluxxLab, LLC
- W.H.P.M, Inc. - H2 Beverages, Inc.
- Bespoke Apothecary, LLC - Lakpura LLC
- Empowered Diagnostics LLC
- Antibody Testing (2) - Transport Media - Self Testing / Nasal Swabs - Rapid Antigen Tests - Variants - BD Max - ThermoFisher - Roche
GENERAL: -
FDA Revoked EUAs & Other Safety Communications Safety Communications (18)
Pandemic Total through 12/31/22
Antibody Testing
Home Test
Storage
Home Test False Negatives TEST-SPECIFIC:
Abbott - Curative - Ellume - Innova - Leccurate
Lepu Medical - Quidel - LuSys Labs - Empowered Diagnostics - E25Bio
Celltrion DiaTrust
SD Biosensor
Q - ACON Flowflex
- Alternative Health Distribution LLC Skippack Medical Labs
- Veterinary Ivermectin -
Use &
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STANDARD
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EUAs 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 12/31/22 Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
Unique Approvals in 2022 Individual EUA for Diagnostic Breath Tests for SARS-CoV-2 - InspectIR COVID-19 Breathalyzer (April 2022) - First COVID diagnostic test using Breath as a Specimen Individual EUA for Genotyping Tests for SARS-CoV-2 - Labcorp VirSeq SARS-CoV-2 NGS Test (June 2022) - New category of COVID EUAs for the identification and differentiation of SARS-CoV-2 phylogenetic assignment of named Global Outbreak (PANGO) lineages Questions: mara.aspinall@asu.edu / sarah.igoe@asu.edu
