Pandemic Test Review 2022

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Testing Commons is made possible with support from The Rockefeller Foundation and Rapid Acceleration of Diagnostics Underserved Population (RADxUP) Questions: Mara G. Aspinall Professor of Practice

1

TestingCommons.com 2022 Summary • H1 2022 EUA Activity: 32 EUAs vs. 86 in H1 2021 • The FDA has clearly shifted its focus away from antibody testing, which along with PCR was the primary subject of new tests for assay developers at the start of the pandemic. Today, not only has interest in antigen tests eclipsed that EUA also caught up to and surpassed activity for molecular tests in H1 2022.

EUA have for serological ones, but Schedule antigenIV tests • 2022 confirmed a transition from the more invasive nasopharyngeal swabs to anterior nasal swabs, with less interest in saliva testing than momentum in 2021 may have suggested. The focus also pivoted away from specialized testing programs and pooled specimen tests.

• The FDA also dedicated some of the first half of 2022 to quality control: they issued 32 warning letters to companies making false COVID-related claims, and the 16 EUAs revoked since last year include everything from PCR assays to reagents, antibody tests, and home antigen tests.

• Two new categories were added by the FDA in 2022 under “Other Tests for SARS-CoV-2 (see slide 22), marking the first official tests approved for breath analysis and for genotypic lineage identification.

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

Schedule IV notifications & Umbrella Molecular EUAs1

EUA

CE-IVD

EU self-certification

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Revoked, Rejected, Withdrawn, Warning letter, Fraud (DOJ) 0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

1400

Pandemic Total through 6/30/22

US FDA Emergency Use Authorizations

250

Molecular

Number of Tests

200

150

Antibody

100

Other

Antigen

50

0

Questions: mara.aspinall @asu.edu

Molecular 86% RTqPCR 10% Isothermal 3% Sequencing 1% CRISPR

Antigen 91% Lateral Flow 9% other

Antibody 63% ELISA 34% Lateral Flow 3% Other

Other Collection Kits Flu/RSV Panels Patient Management

Pandemic Total through 6/30/22

Timeline of EUA Issuances and Amendments by Type 1

1

2

4

3

3

6

1

2

1 3

2

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

4

3 8

14

6

2

1

1

1

28

20

19

2

2 2

1

1

6

6

1

3

2 1

1

1 1

2 12 13

5 4

7

24

21

18 2 2

Flu/RSV

5

3

8

Antibody

1

1

7

3 28

Antigen

2

1

5

8

Molecular

2

4

6

6

6

Questions: mara.aspinall @asu.edu

1 12

10

8

3

Collection Kit

9

13 7

9

1

Pandemic Total through 6/30/22

Profile of US FDA EUAs 300

Lab Authorized to Analyze Sample

# Tests

250 200 150 100

CLIA High Complexity Lab

50

CLIA Moderate Complexity Lab

CLIA Waived / Point of Care Lab

Self Test (No Lab Required)

0 350 Swab

# Tests

250

Sample Type Collected1

200 150 100 50 0

Venous Blood Fingerstick Saliva Blood Breath

Person to Collect Sample2

250

# Tests

300

300

200 150 100 50

Health care or Trained Tech

Self Collect

Pandemic Total through 6/30/22

0 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)

EUAs for Asymptomatic Screening & Serial Screening

Antigen Home, 2

*2 saliva

Molecular Home, 2

Serial Testing – 2 tests in 24-48 hours

*11 saliva

Antigen Home, 14 Molecular POC, 45 Antigen POC, 13 Molecular Home, 1

Questions: mara.aspinall @asu.edu

*1 saliva

Screening (62)

Molecular POC, 7

Serial Screening (35)

Pandemic Total through 6/30/22

51 Antigen Tests with EUAs CLIA High/Moderate (Lab)

Instrument read

Celltrion Sampinute DiaSorin LIAISON Ortho VITROS Qorvo Omnia QIAGEN QIAreach Quanterix Simoa Siemens ADVIA* Siemens Atellica*

Visual read Questions: mara.aspinall @asu.edu

New 2022 H1* and H2** (July)

CLIA Waived (MD Office) BD Veritor BD Veritor + Flu A/B Ellume Luminostics Clip LumiraDx Quidel Sofia FIA Quidel Sofia2+Flu Access Bio CareStart 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

Self Tests BD Veritor Ellume OTC

Access Bio CareStart ACON Flowflex BinaxNOW Home Rx; Self OTC BinaxNOW Telehealth Celltrion DiaTrust Genabio Rapid Self-Test** iHealth Rapid OTC InBios SCoV-2 Self MaximBio ClearDetect* OraSure Inteliswab RX OraSure Inteliswab OTC OSANG OHC Self-Test* PHASE INDICAID At-Home* Quidel QuickVue Rx Quidel QuickVue OTC Roche/SD Biosensor Siemens CLINITEST Xiamen Boson Biotech* Watmind SpeedySwab**

Pandemic Total through 7/15/22

22 EUAs for OTC Self Tests MOLECULAR TESTS (3) • • • • • • • Cue for Home & OTC: • OTC SINGLE • TESTS • • Detect At-Home: SINGLE (22) • Sympt + Serial Asymptomatic • • • Lucira CHECK-IT Test: • SINGLE • • • • Questions: • mara.aspinall New 2022 H1* and H2** (July) • @asu.edu

ANTIGEN TESTS (19) 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 Genabio Rapid Self-Test** Serial: Asympt. & Single: Sympto iHealth COVID-19 Home: Serial: Asympt. & Single: Sympto InBios Int’l Detect Self: Serial: Asympt. & Single: Sympto MaximBio ClearDetect*: Serial: Asympt. & Single: Sympto OraSure InteliSwab Rapid: Serial: Asympt. & Single: Sympto OSANG OHC Self-Test*: Serial: Asympt. & Single: Sympto PHASE INDICAID At-Home* 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 Watmind SpeedySwab**.

Serial: Asympt. & Single: Sympto Pandemic Total Xiamen Boson Rapid Ag Card. Serial: Asympt. & Single: Sympto through 7/20/22

28 EUAs for Respiratory Panels (Flu, RSV, etc.)

30

Number of Tests

25

20

15

10

5

0

Questions: mara.aspinall @asu.edu

Molecular (24) 83% Lab 17% POC

Antigen (3) 100% POC

Collection Kit (1) 100% Molecular

Pandemic Total through 6/30/22

28 EUAs for Respiratory Panels (Flu, RSV, etc.)

Molecular Respiratory Combination Tests (24) • • • • • • • • • • • • • • • • • • • • • • • •

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 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

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

New 2022*

Pandemic Total through 6/30/22

41 EUAs for Testing of Pooled Samples POOL SIZE

Vela Operations [ViroKey PCR]

• •

2

(1 Test) •

BayCare [SARSCoV-2 RT PCR Assay]

3

(1 Test) • •

4

(2 Tests)

5

(26 Tests)

CDC [RT-PCR Diagnostic Panel] Quest [SARS-CoV-2 rRT-PCR]

• 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

Quest [RC SARSCoV-2 Assay] Roche [cobas SARS-CoV-2]

6

• •

BioFire [COVID-19 Test] Cepheid [Xpert Xpress SARS-CoV-2]

7

(2 Tests)

(1 Test) •

Poplar [TMA Pooling assay]

• 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]

8

(2 Tests)

10

12

(4 Tests)

(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

Quadrant Biosciences [Clarifi COVID-19 Test Kit] Verily [COVID-19 RTPCR Test]

Pandemic Total through 6/30/22

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

25

Number of Tests

20

15

10

5

0

Questions: mara.aspinall @asu.edu

Swab (16) 57% Rx 43% DTC

Rx: requires prescription DTC: direct to consumer

Saliva (7) 57% Rx 43% DTC

Pandemic Total through 6/30/22

23 EUAs for Independent Home Specimen Collection Kits Swab Collection Kits (16) • • • • • • • • • • • • • • • •

Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA’s

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

New Q2 2022*

Pandemic Total through 6/30/22

CE-IVD Certified Tests (Mostly Europe) Antigen

500 450

Number of Tests

400 350

Antibody

Molecular

300 250 200 150

Other

100 50 0

Questions: mara.aspinall @asu.edu

Molecular 88% RTqPCR 6% Isothermal 6% Other

Antigen 59% Lateral Flow 5% ELISA 37% Other

Antibody 36% Lateral Flow 45% ELISA 18 % Other

Other Collection Kits Flu/RSV Panels Breath/VOC

Pandemic Total through 6/30/22

Research Use Only Tests 250

Molecular

Antibody

Number of Tests

200

150

100

Antigen

Other

50

0

Questions: mara.aspinall @asu.edu

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 6/30/22

Tests in Development Worldwide 120

Molecular

Number of Tests

100

Antigen

80

Antibody

60 40

Other

20 0

Questions: mara.aspinall @asu.edu

Molecular 38% RTqPCR 23% Isothermal 14% CRISPR 13% Sequencing 13% Other

Antigen 58% Lateral Flow 17% ELISA 9% Breath 16% Other

Antibody 62% Lateral Flow 30% ELISA 8% Other

Other Breath / VOC Mass Spec Raman Spec

Pandemic Total through 6/30/22

Companies with the Largest Number of EUAs 12

13

12

Number of Tests

10

11

10

8

9

8

6

7

7

6

4

5

5

5

2 0

Siemens

Abbott

1 Molecular 5 Molecular 3 Antigen 4 Antigen 8 Antibody 3 Antibody 1 Pt Mgmt

Roche

Quest

Danaher*

Quidel

Thermo Fisher

InBios Int'l

BD

Color Health Access Bio LabCorp

1 Molecular 2 Molecular 2 Molecular 1 Molecular 5 Molecular 7 Molecular 8 Molecular 5 Molecular 3 Molecular 1 Antigen 2 Collection 3 Antibody 5 Antigen 6 Molecular 2 Antigen 3 Antigen 3 Collection 2 Antigen 2 Antibody 1 Antibody 4 Antibody 1 Pt Mgmt Kits 2 Antibody Kits 1 Pt Mgmt 1 Pt Mgmt Pandemic Total *Cepheid + Beckman Coulter

18

through 6/30/22

FDA Revoked EUAs & Other Safety Communications •

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.

Warning Letters (39)

Letters to Healthcare Providers (15) Safety Communications (9) Revoked Antigen EUA (5)

Revoked Molecular EUA (15) Questions: mara.aspinall @asu.edu

Revoked Antibody EUA (171)

Pandemic Total through 6/30/22

Other FDA Safety Communications by Subject Warning Letters

- Viraldine, LLC - Soda Pharm - Blue Willow Biologics - Ivermectin24h.com - Invisi Smart Technologies - Jordan’s Crossing Herbal Connections - Iotech International LLC - Applied Biological Laboratories, Inc - Kaleido Biosciences, Inc. - Iodine Products Inc - Mahita, LLC dba PushMyCart - Agropharma Laboratories, Inc. - Rxmedcart.com - Heaven's Organic LLC - Shanghai Dasheng - UPSY LLC - Varigard, LLC - Nature's Highway - Amcyte Pharma, Inc. - Functional Remedies, LLC D/B/A - Genesis Partnership Company SA Synchronicity Hemp Oil - CES LLC - CBD Social - Frozen Wheels, LLC - Heaven's Organic LLC - Avila Herbals, LLC - UPSY LLC - Glenn Burkett Naples Corporation - Pharmacy2Home/LandiCom Holding - Sensory Cloud, Inc - CoFixRx, LLC LTD - Santhigram Kerala Ayurvedic Co. of - Extrapharmacy.ru U.S., Inc. - Rxshopmd.com - Haniel Concepts, Inc. DBA Free State - CytoDyn, Inc Oils, LLC - My Natural Treatment - Lusys Laboratories, Inc - Bea Lydecker's Naturals, Inc.

Questions: mara.aspinall @asu.edu

Safety Communications - LuSys Labs - Empowered Diagnostics (Tests) - Abbott - Curative - Ellume - Innova - Leccurate - Lepu Medical - Quidel

- E25Bio - Celltrion DiaTrust - SD Biosensor STANDARD Q - ACON Flowflex - Skippack Medical Labs

Safety Communications (General) - Antibody Testing - Veterinary Ivermectin - Home Test Use & Storage Letters to Health Care Providers - Antibody Testing (2) - Transport Media - Self Testing / Nasal Swabs - Rapid Antigen Tests - Variants Letters to Health Care Providers - BD Max Pandemic Total - ThermoFisher through 6/30/22 - Roche

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)

Questions: mara.aspinall @asu.edu

Pandemic Total through 6/30/22

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

Timeline of EUA Issuances, Pandemic through June 2022

9 200

150

58

11

Collection Kit Flu/RSV Antibody Antigen Molecular

17 100 155

25 28

50

46 0

Questions: mara.aspinall @asu.edu

2 2 8 18

2020

2021

2022 H1 Pandemic Total through 6/30/22

Acknowledgements Special thanks to: • ASU College of Health Solutions for leadership in Biomedical Diagnostics • Sarah Igoe, MD, for her great work on TestingCommons.com • Nate Wade, PhD, for his continued partnership on ASUCovidCommons.com • Dean Deborah Helitzer for her support for all Covid Commons efforts

• ASU Decision Theater

• The team’s work is critical to the success of all our programs

• The Rockefeller Foundation

• For the enabling grant for TestingCommons.com and all parts of ASUCovidCommons.com

• Rapid Acceleration of Diagnostics Underserved Populations (RADxUP) • For the 2022 grant for TestingCommons.com

• Mara G. Aspinall