METADATA last updated: 2026-03-06 by BA file_name: 2021-06-31_Testing Commons - ASU and Rockefeller.md file_date: 2021-06-31 title: 2021-06-31_Testing Commons - ASU and Rockefeller category: various subcategory: external-programs-reports tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive-wip/main/various/external-programs-reports/2021-06-31_Testing%20Commons%20-%20ASU%20and%20Rockefeller.NA pdf_gdrive_url: https://drive.google.com/file/d/1m_gTH8wy_efWW3tnJcbfEmDBXwIggf0u pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive-wip/blob/main/various/external-programs-reports/2021-06-31_Testing%20Commons%20-%20ASU%20and%20Rockefeller.pdf conversion_input_file_type: pdf conversion: megaparse license: 3rd Party tokens: 4189 words: 2048 notes: summary_short: The TestingCommons.com Pandemic Review is a slide-style overview from Arizona State University’s COVID Diagnostics Commons that summarizes global COVID-19 tests and regulatory statuses, including U.S. FDA EUA categories and key attributes (lab/POC/home, screening, serial screening, pooling). It compiles pandemic-era counts and charts (through 6/30/21) showing distributions by test type and technology, plus related safety actions and communications. CONTENT ## Slide 1: COVID-19 Testing Commons **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 ## Slide 2: TestingCommons.com Pandemic Review _horizontal bar chart showing count (x-axis) by test/authorization status category (y-axis), including FDA EUA, LDT, CE-IVD, Research Use Only, Development, and FDA Revoked._ FDA EUA - Molecular, Antigen, Serology, & T-Cell Tests, Patient Management, Combination Respiratory Panels, and Collection Kits LDT - Schedule IV notifications & Umbrella Molecular EUAs¹ CE-IVD - EU self-certification Research Use Only - Authorized by government jurisdiction in country outside of US/EU Development - Tests & Technologies publicly announced to be under development FDA Revoked - Revoked, Rejected, Withdrawn, Warning letter, Fraud (DOJ) 1. nla after 10/7/20 when HHS/FDA announced policy to not require authorization for any LDT 2. 19% of tests with approval internationally have been granted EUA by the US FDA Pandemic Total through 6/30/2021 ## Slide 3: 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 ## Slide 4: US FDA Emergency Use Authorizations _bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_ Molecular - 88% RTqPCR - 9% Isothermal - 3% Sequencing - 1% CRISPR Antigen - 88% Lateral Flow - 8% Chemiluminescence - 4% other Antibody - 60% ELISA - 31% Lateral Flow - 6% Chemiluminescence Other - Collection Kits - Flu/RSV Panels - Patient Management Pandemic Total through 6/30/2021 ## Slide 5: Timeline of EUA Issuances and Amendments _stacked bar chart showing month (x-axis) versus number of tests (y-axis), broken down by Molecular, Antigen, Antibody, Flu/RSV, and Collection Kit._ ## Slide 6: Profile of US FDA - EUA's Lab Authorized to Analyze Sample _bar chart showing lab authorization type (x-axis) versus number of tests (y-axis) for labs authorized to analyze samples (CLIA high/moderate complexity, CLIA waived/POC, self test)_ Sample Type Collected(1) _bar chart showing sample type collected (x-axis) versus number of tests (y-axis) (anterior nasal swab, nasopharyngeal swab, saliva, venous blood, fingerstick blood)_ Person to Collect Sample(2) _bar chart showing sample collector (x-axis) versus number of tests (y-axis) (healthcare/trained tech vs self)_ 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) ## Slide 7: 11 EUA's for Comprehensive At-Home Tests | | Molecular Tests (3) | Antigen Tests (8) | | ------------- | -------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | RX Tests (4) | • Lucira COVID-19 All-In-One Test Kit | • Abbott BinaxNOW COVID-19 Ag Card Home Test
• OraSure InteliSwab COVID-19 Rapid Test Rx
• Quidel QuickVue At-Home OTC COVID-19 Test | | OTC Tests (7) | • Cue COVID-19 Test for Home and Over The Counter (OTC) Use
• Lucira CHECK-IT COVID-19 Test Kit | • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test
• Abbott BinaxNOW COVID-19 Antigen Self Test
• Ellume COVID-19 Home Test
• OraSure InteliSwab COVID-19 Rapid Test
• Quidel QuickVue At-Home OTC COVID-19 Test | || Pandemic Total through 6/30/2021 ## Slide 8: EUA's for Asymptomatic Screening & Serial Screening A. PROPOSED INTENDED USE FDA recommends including the following in the requested intended use: [...individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.] Collection Kit, 10 <-- *3 saliva Antigen Home, 1 Molecular Home, 2 Molecular POC, 36 <-- *4 saliva Screening (49) Antigen Home, 5 Antigen POC, 6 Molecular POC, 3 <-- *1 saliva Serial Screening (14) ## Slide 9: 28 Antigen Tests with EUAS | | CLIA High/Moderate (Laboratory) | CLIA Waived (Physician Office) | Home | | --------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------ | | Instrument read | Celltrion Sampinute
DiaSorin LIAISON
Ortho VITROS
Qorvo Omnia
Quanterix Simoa | BD Veritor
BD Veritor + Flu A/B
Luminostics Clip
LumiraDx
Quidel Sofia FIA
Quidel Sofia2+Flu | Ellume OTC | | Visual read | | Access Bio CareStart
BinaxNOW Card
BinaxNOW 2 Card
Celltrion DiaTrust
InBios SCoV-2
OraSure InteliSwab Pro
Princeton Status+Flu
Salofa Sienna-Clarity
Quidel QuickVue | BinaxNOW Home Rx
BinaxNOW Self OTC
BinaxNOW Telehealth
OraSure InteliSwab RX
OraSure InteliSwab OTC
Quidel QuickVue Rx
Quidel QuickVue OTC | || Pandemic Total through 6/30/2021 ## Slide 10: 18 EUA's for Respiratory Panels (Flu, RSV, etc.) _bar chart showing test type (x-axis) versus number of tests (y-axis), comparing Molecular and Antigen tests_ Molecular (15) - 67% Lab - 33% POC Antigen (3) - 100% POC Pandemic Total through 6/30/2021 ## Slide 11: 18 EUA's for Respiratory Panels (Flu, RSV, etc.) Molecular Respiratory Combination Tests (15) •Abbott Alinity m Resp-4-Plex •BD for BD MAX system •BioFire Diagnostics Respiratory Panel 2.1 EZ •Bio-Rad Reliance •CDC Flu C2 Multiplex Assay •Cepheid Xpert Xpress •GenMark ePlex Respiratory Pathogen Panel 2 •Hologic Aptima •Luminex NxTAG Respiratory Pathogen Panel + SARS-CoV-2 •NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay •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 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 Pandemic Total through 6/30/2021 ## Slide 12: 28 EUA’s for Testing of Pooled Samples | Pool size | Tests | | ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 2 (1 Test) | BayCare [SARS-CoV-2 RT PCR Assay] | | 4 (2 Tests) | CDC [RT-PCR Diagnostic Panel]
Quest [SARS-CoV-2 rRT-PCR] | | 5 (15 Tests) | Abbott [Alinity m SARS-CoV-2 assay]
Amazon DTC [Real-Time RT-PCR Test for Detecting SARS-CoV-2]
Amazon [Real-Time RT-PCR Test for Detecting SARS-CoV-2]
Applied BioCode [SARS-CoV-2 Assay]
Enzo [AMPIPROBE SARS-CoV-2 Test System]
Hologic [Aptima SARS-CoV-2 assay]
Hologic [Panther Fusion SARS-CoV-2 Assay]
Labcorp [COVID-19 RT-PCR Test]
Labcorp [Pixel Home Collection Kit]
OPTI [Sars-CoV-2 RT-PCR Test]
PerkinElmer [New COVID Nucleic Acid Detection Kit]
SML GENETREE [Ezplex SARS-CoV-2 G Kit]
Thermo Fisher TaqPath
UCSD [RC SARS-CoV-2 Assay]
Viracor Eurofins [SARS-CoV-2 assay] | | 6 (2 Tests) | Quest [RC SARS-CoV-2 Assay]
Roche [cobas SARS-CoV-2] | | 7 (1 Test) | Poplar [TMA Pooling assay] | | 8 (2 Tests) | BioFire [COVID-19 Test]
Cepheid [Xpert Xpress SARS-CoV-2] | | 12 (2 Tests) | Quadrant Biosciences [Clarifi COVID-19 Test Kit]
Verily [COVID-19 RT-PCR Test] | || Pandemic Total through 6/30/2021 ## Slide 13: 16 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 _bar chart showing sample type (x-axis) versus number of tests (y-axis), comparing Swab and Saliva tests_ Swab (10) - 50% Rx - 50% DTC Saliva (6) - 67% Rx - 33% DTC Pandemic Total through 6/30/2021 ## Slide 14: 16 EUA's for independent Home Specimen Collection Kits Swab Collection Kits (10) •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 •GetMyDNA COVID-19 Test Home Collection Kit •Kroger Health COVID-19 Test Home Collection Kit •RapidRona Self-Collection Kit Saliva Collection Kits (6) •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 COVID- 19 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 Pandemic Total through 6/30/2021 ## Slide 15: CE-IVD Certified Tests (Mostly Europe) _bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_ Molecular - 91% RTqPCR - 8% Isothermal - 1% Sequencing Antigen - 78% Lateral Flow - 5% ELISA - 15% Other Antibody - 49% Lateral Flow - 42% ELISA - 6% Other Other - Collection Kits - Flu/RSV Panels Pandemic Total through 6/30/2021 ## Slide 16: Research Use Only Tests Authorized outside US & EU _bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_ Molecular - 88% RTqPCR - 9% Isothermal - 1% Sequencing Antigen - 69% Lateral Flow - 27% ELISA - 4% Other Antibody - 51% Lateral Flow - 47% ELISA - 3% Other Other - Collection Kits - Flu/RSV Panels Pandemic Total through 6/30/2021 ## Slide 17: Tests in Development Worldwide _bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_ Molecular - 40% RTqPCR - 23% Isothermal - 16% CRISPR - 14% Sequencing Antigen - 56% Lateral Flow - 18% ELISA - 10% Breath - 16% Other Antibody - 63% Lateral Flow - 25% ELISA - 12% Other Other - Breath / VOC - Mass Spec - Raman Spec Pandemic Total through 6/30/2021 ## Slide 18: Companies with the largest number of EUAS _bar chart showing company/vendor (x-axis) versus number of tests (y-axis)_ Abbott - 4 Molecular - 5 Antigen - 3 Antibody Siemens - 1 Molecular - 10 Antibody Quidel - 3 Molecular - 5 Antigen Roche - 6 Molecular - 1 Antigen - 2 Antibody Quest - 6 Molecular - 1 Antigen - 2 Antibody BD - 4 Molecular - 1 Antigen - 2 Antibody Color Health - 4 Molecular - 1 Antigen - 2 Antibody Diasorin - 1 Molecular - 1 Antigen - 3 Antibody Thermo Fisher - 3 Molecular - 2 Antibody Pandemic Total through 6/30/2021 ## Slide 19: FDA Revoked EUA's and Other Safety Communications * 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. _pie chart_ Letters to Healthcare Providers (9) Safety Communications (5) Revoked Antigen EUA (5) Revoked Molecular EUA (7) Revoked Antibody EUA (167) Pandemic Total through 6/30/2021 ## Slide 20: Other FDA Safety Communications by Subject _pie chart_ Letters to Health Care Providers - BD Max - ThermoFisher - Roche Letters to Health Care Providers - Antibody Testing (2) - Transport Media - Self Testing / Nasal Swabs - Rapid Antigen Tests - Variants Safety Communications - Antibody Testing Safety Communications - Curative - Leccurate - Lepu Medical - Innova Pandemic Total through 6/30/2021 ## Slide 21: EUA's for Management of COVID-19 Patients IVDs for Management of COVID-19 Patients (3) - Roche Diagnostics Elecsys IL-6 (June 2020) - Beckman Coulter, Inc. Access IL-6 (October 2020) - Siemens Healthcare Diagnostics Inc. ADVIA Centaur IL6 Assay Pandemic Total through 6/30/2021 ## Slide 22: New EUAS by Technology Q1 2021 (n=41) Total Q1 2021 New EUA's _stacked bar chart showing test category (x-axis) versus number of new EUAs in Q1 2021 (y-axis)_ Molecular Tests 1 - Comprehensive At-Home Tests 6 - Flu/RSV Combo Tests 14 - Lab /POC COVID only Antigen Tests 3 - Comprehensive At-Home Tests 1 - Flu/RSV Combo Tests 3 - Lab /POC COVID only Serology Tests 10 - Lab /POC COVID only Collection Kits 3 - Lab /POC COVID only Collection Kits are listed separately as their own category by Testing Commons Pandemic Total through 6/30/2021 ## Slide 23: New EUAs by Technology Q2 2021 (n=43) Total Q2 2021 New EUA's _stacked bar chart showing test category (x-axis) versus number of new EUAs in Q2 2021 (y-axis)_ Molecular Tests 1 - Comprehensive At-Home Tests 6 - Flu/RSV Combo Tests 13 - Lab /POC COVID only Antigen Tests 2 - Comprehensive At-Home Tests 5 - Lab /POC COVID only Serology Tests 8 - Lab /POC COVID only Collection Kits 9 - Lab /POC COVID only