COVID-19 IVD Test Tracker

The worldwide COVID-19 crisis has spawned hundreds of diagnostic testing kits and daily announcements.  How do you sort out the significant tests with large distribution and market share from promising startups or low volume companies? This Kalorama COVID-19 IVD Test Tracker will update on new EUAs with information and analysis from Kalorama analysts, updated on a regular basis.  Kalorama Information has covered diagnostics for 2 decades. Our major global IVD market report for global market estimates in infectious disease testing, molecular diagnostics, oncology testing, hematology, critical care testing and other areas is The Worldwide Market for In Vitro Diagnostic Tests, now in its 12th Edition.

FDA Test Authorizations of IVD Products Over Time

There’s been a steady increase in IVD Test Product EUAs over time.  Over a month ago, only the CDC’s own test was available.  Roche’s cobas test approval became the first commercial test, and then many other EUAs followed.

Significant new EUAs include Quidel’s Direct Test (no RNA extraction kit required), Abbott’s Alinity m Test, Everlywell’s Home Collection Kit, Quidel’s Sofia Antigen Test, Sherlock CRISPR test, Biomerieux’s R-GENE 2 triplex PCR test (for covering possible COVID-19 mutations).   Bio-Rad’s dPCR test, Roche and Abbott high-throughput Serology tests.

The United State is currently where most COVID-19 testing is occurring, thus tracking the IVD EUA is most important.   This chart details FDA Emergency Use Authorization (EUA)s over time.  This chart does not include lab-developed tests (LDT) at universities, hospital medical centers or states that may use the IVD products.

Authorized Test from Top-Tier IVD Companies

There is a large variety of tests on the market.  Major IVD players are involved.  Abbott, Roche, Siemens, Thermo Fisher, Bio-Rad and Beckman Coulter are among the top companies in the IVD market, and they have tests in the market, as indicated on the chart below:

 

IVD Test Authorizations by Technology Type

RT-PCR is the gold standard and molecular tests are by their nature slightly faster to develop when a virus has a known genetic signature, as is the case with SARS-CoV-2.  Therefore it’s not surprising to see most EUAs  consist of PCR tests, though anti-body tests are increasingly netting authorizations:

Lab-Developed tests are tests run by a specific laboratory using a procedure approved by the FDA versus a test kit that is widely distributed.  Mount Sinai and the CDC itself are among those labs.  Antigen tests test for the cell particles of the virus rather than an antibody, but do so with a non-molecular method.

Both lab based testing and point-of-care (POC) test systems are utilized.  Because of the complex nature of molecular testing most authorizations are for Lab-Based Tests, tests performed by highly trained technicians at laboratories:

 

Serology Tests

Much broader testing is envisioned as a way to enable society to more quickly “reopen” through a more informed and calculated process. But the impact could be minimal, if the disease prevalence turns out to be in the realm of 5% or lower as it appears to be in the U.S., and if the reopening is abrupt rather than a very incremental process. The dynamics are dictated more by the timing of the loosening of social distancing guidelines and by how many people have been exposed.  After announcements and approvals of a few startup companies and international concerns, major vendors such as Siemens and Abbott have produced tests.

Recently, the FDA created a new umbrella pathway for the increasing amount of serology tests.  Tests will be evaluated by an inter-agency group (though media reports indicate that currently the National Cancer Institute is conducting the tests).  For authorization, tests are run against  at least 30 samples that are positive for anti-SARS Cov-2  If the test is applying for authorization for both IgM and IgG antibodies, the test must be run against positive samples for both.  The test must perform against SARS-Cov-2 negative samples as well: the test must be run against 80 confirmed antibody negative samples or pre-COVID-19 samples.  Because HIV Has recently been a concern, 10 of these 80 negative samples being HIV positive.   IgM/IgG tests Sensisitivity and Specificity must be 90% and 95% respectively to move forward

Accuracy Concerns  

With molecular testing – the sensitivity and specificity of any well-constructed and validated nucleic acid tests for COVID-19 is very high, they detect molecules that are specific to SARS-CoV-2.  meaning that a positive result can generally be trusted.  With antibody tests, the same confidence does not yet exist.  Specificity can vary by assay.  One factor to assess is how many samples the test was run against for both negative and positive samples in the the validation step.  Abbott for instance, used 1,000 samples.  Other manufacturers citing high specificity rates have tested on a few dozen samples, or are simply not revealing that data.

In addition, even if stated sensitivity and specificity are accepted, small amounts of sensitivity differences make big differences in accuracy, particularly with tests on a large population.  If testing occurs without any clinical steps that might increase the chances patient is positive (testing only healthcare workers, patients with symptoms or with history with COVID-19 patient, for instance.) and 5% is the estimated prevalence of Covid-19 in the U.S., false positives in antibody test systems can amplify inaccuracy.  This chart reveals the difference between sensitivity and the positive predictive value (PPV), essentially the chance a test is wrong.

 

Antigen Test

Clearance of Quidel’s rapid antigen diagnostic test by the U.S. Food and Drug Administration (FDA) marks the arrival of a third type of assay for the novel coronavirus, with promise to help scale up as states reopen their economies.  Quidel’s Sofia 2 SARS antigen point-of-care (POC) test is designed for use with the company’s Sofia 2 fluorescent immunoassay analyzer. On May 9, the FDA granted emergency use authorization (EUA) for the test for use by CLIA-certified moderate- and high-complexity labs and facilities that have a CLIA waiver.

The assay detects fragments of proteins found on or within SARS-CoV-2 in nasal or nasopharyngeal specimens. According to the company, the test delivers results in 15 minutes.

Quidel’s Sofia 2 SARS assay delivers results in 15 minutes, according to the company.

Saliva Testing

There is considerable focus on the Rutgers University Saliva test, which has received EUA and is being used in New Jersey walk-in and drive-through test locations.  According to an article in the New York Times

“While not as fast to process as the speediest swab tests, saliva tests could transform the diagnosis of Covid-19…The Rutgers lab has already processed close to 90,000 tests, according to its chief executive, Andrew Brooks, and expects to ramp up eventually to 30,000 tests per day. Results are available within 72 hours, although they could be sped up to just a few hours with enough infrastructure in place. By contrast, some rapid tests that rely on swabs deliver results in minutes…The next step would be an at-home saliva test kit that skirts even the need to go to a walk-in center”

Oral fluid samples can provide nasopharyngeal fluid, can be just as accurate as swabs – at least in controlled flu studies — and are currently used for drug tests and HIV tests currently.  The advantage of such tests is the ease of sample, and the reduction of  risk to the test takers compared to other test methods.

 

Every Currently Authorized Tests for COVID-19

We list all tests authorized by the FDA in the United States or the EU (and participating countries) through the CE Mark program.  Where possible, installed base information and throughput information is provided.

 

Roche cobas
cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
PCR
Lab-Based
827
240-900
FDA EUA/CE Mark
View Source
ThermoFisher
TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
PCR
Lab-Based
4,500
200
FDA EUA/CE Mark
View Source
Abbott m2000
Abbott RealTime SARS-CoV-2 assay (Abbott Molecular)
PCR
Lab-Based
250
150
FDA EUA
View Source
Abbott IDNOW
ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.)
PCR
POC
4,700
32
FDA EUA
View Source
Chembio
DPP COVID-19 IgM/IgG System
Antibody
POC
N/A/>
N/A
FDA EUA
Cepheid
Xpert Xpress SARS-CoV-2 test (Cepheid)
PCR
POC
23,000
140
FDA EUA
View Source
BioFire
BioFire COVID-19 Test (BioFire Defense, LLC)
PCR
POC
11,000
75
FDA EUA
View Source
Hologic
Panther Fusion SARS-CoV-2 (Hologic, Inc.)
PCR
Lab-Based
1,800
380
FDA EUA
View Source
BD Max
BD SARS-CoV-2Reagents for BD MAX System (Becton, Dickinson & Company)
PCR
Lab-Based
150
60
FDA EUA
View Source
Simplexa/DiaSorin
Simplexa COVID-19 Direct for LIASAON
PCR
Lab-Based
800
64
FDA EUA
View Source
Luminex NxTAG
NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.)
PCR
Lab-Based
65
192
FDA EUA
View Source
Qiagen
QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH)
PCR
POC
200
50
FDA EUA
View Source
Quest
Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
PCR
LDT
N/A
25,000
FDA EUA
View Source
LabCorp
COVID-19 RT-PCR Test (Laboratory Corporation of America)
PCR
LDT
N/A
14,000
FDA EUA
View Source
GenMark
ePlex SARS-CoV-2 Test
PCR
POC
580
96
FDA EUA
View Source
BGI
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (BGI Genomics Co. Ltd)
PCR
Lab-Based
500
50
FDA EUA/CE Mark/China FDA
View Source
Quidel
Lyra SARS-CoV-2 Assay (Quidel Corp.)
PCR
Lab-Based
550
200
FDA EUA
View Source
Seegene Allplex 2019-nCoV Assay
 Allplex 2019-nCoV Assay
PCR
Lab-Based
100
45
CE Mark (EU)
View Source
bioMérieux
SARS-COV-2 R-GENE® (ref 432720) (CE-IVD)
Lab-Based
300
45
CE mark
View Source
Mesa Biotech
Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
PCR
POC
10000
32
FDA EUA
View Source
Perkin Elmer
Nucleic Acid Detection Kit for chemagic
PCR
Lab-Based
N/a
96
FDA EUA
View Source
BD/Biomedics
Rapid IgM-IgG Combined Antibody Test For Coronavirus
Antibody
POC
N/A
96
CE Mark (EU)
View Source
Luminex ARIES
ARIES SARS-CoV-2 Assay (Luminex Corporation)
PCR
Lab-Based
320
48
FDA EUA
View Source
Cellex
Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)
Antibody
POC
10000
32
FDA EUA
View Source
Centers for Disease Control
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC)
PCR
LDT
N/a
100
FDA EUA
cdc.gov   (CDC is in supportive role at this time)
Viracor Eurofins
Viracor SARS-CoV-2 assay
PCR
LDT
N/a
N/a
FDA EUA
View Source
Solgent Co.Ltd
DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit (Korea FDA-EUA –  )
100
45
Korea FDA
Snibe
MAGLUMI 2019-nCoV IgM/IgG kit
Antibody
Lab-Based
200-400
600
CE Mark (EU)/China FDA
Kogene
2019 Novel Coronavirus Real-time PCR K
Lab-Based
100
50
Korea FDA
View Source
Wadsworth Center, NYSDOH
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)
PCR
LDT
N/A
200
FDA EUA
View Source
NeuMoDx
NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
PCR
Lab-Based
50-200
168
FDA EUA
View Source
SD Biosenso b Std M nCoV Real Time Kit
Lab-Based
N/A
108
CE Mark (EU)
View Source
Co-Diagnostics
Logix Smart Coronavirus Disease 2019  Kit
PCR
POC
N/a
N/a
FDA EUA
View Source
Vela Diagnostics ViroKey SA201 SARS-CoV-2 RT-PCR Test
PCR
POC
N/A
N/A
CE Mark (EU)
View Source
Stanford
Stanford SARS-CoV-2 assay
PCR
LDT
N/A
N/A
FDA EUA
View Source
Daan Diagnostics
Real Time PCR Kit
PCR
Lab-Based
N/A
N/A
CE Mark (EU)/China FDA
PrimerDesign
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd)
PCR
Lab-Based
N/A
N/A
FDA EUA
View Source
Northwestern University Medicine
SARS-Cov-2 Assay Northwestern
PCR
LDT
N/A
N/A
FDA EUA
View Source
Yale Haven Hospital
ARS-CoV-2 PCR test
PCR
LDT
N/A
200
FDA EUA
View Source
Childrens Hospital of Philadelphia
SARS-CoV-2 RT-PCR test
PCR
LDT
N/A
N/A
FDA EUA
View Source
Massachusetts General Hospital
MGH COVID-19 qPCR assay
PCR
LDT
N/A
N/A
FDA EUA
View Source
Avellino
AvellinoCoV2 test (Avellino Lab USA, Inc.)
PCR
Lab-Based
N/A
N/A
FDA EUA
View Source
Genomegen
Gnomegen COVID-19 RT-Digital PCR Detection Kit (Gnomegen LLC)
PCR
Lab-Based
N/A
N/A
FDA EUA
View Source
Atila BioSystems, Inc.
iAMP COVID-19 Detection Kit
isothermal
Lab-Based
N/A
N/A
FDA EUA
View Source
Biomedica
SARS Antibody Test
Antibody
POC
N/A
N/A
No Auth.
View Source
Ipsum
COV-19 IDx assay (Ipsum Diagnostics, LLC)
PCR
POC
N/A
N/A
FDA EUA
View Source
DiaCarta
QuantiVirus SARS-CoV-2 Test kit (DiaCarta, Inc.)
qPCR
Lab-Based
N/A
N/A
FDA EUA
View Source
InBios
Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.)
PCR
Lab-Based
N/A
N/A
FDA EUA
View Source
Altona Diagnostics
RealStar 2019-nCoV Real Time PCR Kit
PCR
Lab-Based
N/A
N/A
CE Marked
View Source
Wuxi Diagnostics
2019-nCoV Fluorescent PCR
PCR
Lab-Based
N/A
N/A
CE Marked
View Source
Veredus Laboratories
 VereCoV Detection Kit
PCR
Lab-Based
N/A
N/A
CE, Singapore HAS
View Source
1drop
1copy COVID-19 qPCR Kit (CE-IVD) 1drop
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
3Dmed
ANDiS® SARS-CoV-2 RT-qPCR Detection
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Biomaxima
 SARS-CoV-2 Test
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Biotec Biomedical  SARS-CoV-2
SARS-CoV-2 Test
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
CTK
CTK Biotech Aridia COVID-19 Real-Time PCR test
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
AlphaBiolabs 
IgM-IgG Combined Antibody Rapid Test
Antibody
POC
N/A
N/A
N/A
View Source
SunStar
SunStar LAMP-COVID-19
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Sansure
Sansure Biotec 2019-nCoV
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Kewei
Kewei Diagnostics Kewei COVID-19 Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
LifeRiver
LifeRiver Liferiver Real Time Multiplex RT-PCR
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Gencurix
Gencurix GenePro COVID-19 Detection Test
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
AssayGenie
AssayGenie COVID-19 CE IVD qPCR assay
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Beijing Applied Technology
Beijing Applied Biological ORF1ab Gene Triple Fluor. PCR
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Getein
Getein Biotech Novel Coronavirus Real Time PCR
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Kogene
Kogene PowerChek Real Time PCR
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Boditech
Boditech Inc ExAmplar COVID-19 RT PCR kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Amoy Diagnostics
PCR
Lab-Based
N/a
N/a
CE Mark
View Source
Edinberg Genetics
PCR
Lab-Based
N/a
N/a
CE mark
View Source
Molbio Diagnostics
Pvt Ltd Truenat SARS CoV-2
PCR
POC
India DCGI
View Source
ScienCell
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (ScienCell Research Laboratories)
PCR
Lab-Based
N/A
N/A
FDA EUA
View Source
Amplidiag COVID-19
PCR
PCR
Lab-Based
N/A
N/A
Finland
View Source
Acumen Research Laboratories (Singapore HSA)
Acu-Corona 2.0
PCR
Lab-Based
N/A
N/A
HAS-Singapore
View Source
AMD
 Zena Max – SARS-COV-2 Real Time PCR Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
AITbiotech
abTES COVID-19 qPCR I Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Aldatu Biosciences
PANDAA qDx SARS-CoV-2 (In development)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Amoy Diagnostics Co
 AmoyDx® Novel Coronavirus (2019 nCoV) Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Amplicon Ltd
AmpliTest SARS-CoV-2 (Real Time PCR)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Anatolia Geneworks
 Bosphore Novel Coronavirus
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Anhui Anlong Gene Technology Co.
   Detection Kit for 2019-nCov nucleic acid (Fluorescence PCR)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
AniCon Labor GmbH
Kylt® SARS-CoV-2 Confirmation RT-qPCR
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Beijing Microread Genetics Co.,Ltd C
COVID-19 (SARS-CoV-2) Detection Kit (LAMP) – lab-based or near-POC
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Bioeksen R&D Technologies
Bio-Speedy SARS-CoV-2 (2019-nCoV) qPCR Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
BIONEER Corporation
AccuPower® SARS-CoV-2 Real-Time RT-PCR kit (manual kit: SCV-2122)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Shenyang  Group Ltd
Colorimetric and Isothermal Detection Kit for COVID-19 Coronavirus
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Cancer Rop Co., Ltd.
Q-Sens® 2019-nCoV Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
CapitalBio Technology
Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
CerTest Biotec, S.L.
VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Diagnostics for the Real World Ltd
SAMBA II COVID-19 Test (near-POC NAT)
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Eurobio Scientific
 EurobioPlex SARS-CoV-2 Multiplex
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
EUROIMMUN AG
EURORealTime SARS-CoV-2
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Gencurix Inc.
GenePro COVID-19 Detection Test
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
GeneMatrix Inc.
 NeoPlex COVID-19 Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
GeneMe Advanced
One Step FAST Covi19 KIT Two Genes Set
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
GenomCan Inc.
Fluorescent PCR Probe Detection Kit for SARS-CoV-2
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
KRISHGEN BioSystems
SARS-CoV-2 (Covid-19) Real-Time PCR Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Krosgen Biotech
KrosQuanT SARS-COV- 2 (2019 nCOV) Realtime PCR Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Liming Bio-Products Co.
 SrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Vazyme Medical Technology Co., Ltd
2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Progenie Molecular
S.L.U. RealCycler CORO
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Sacace BIOTECNOLOGIES
Sacace BIOTECNOLOGIES SARS-CoV-2
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Sente Biolab
Senteligo Covid-19 qRT PCR Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Systaaq Diagnostic Prouducts
 Systaaq 2019-Novel Coronavirus  Real Time PCR Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Tellgen Corporation
  SARS-CoV-2 Nucleic acids detection kit based on Real-Time PCR platform
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Vircell, S.L.
SARS-COV-2 REALTIME PCR KIT
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Wuhan HealthCare Biotechnology Co., Ltd
Corona Virus Disease 2019 (COVID-19) Nucleic Acid Detection Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Xiamen Zeesan Biotech Co., Ltd.
 SARS-CoV-2 Test Kit
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
Xi’an Goldmag Nanobio Tech Co., Ltd
Xi’an Goldmag Nanobio Real-Time RT-PCR assays
PCR
Lab-Based
N/A
N/A
CE Mark
View Source
 Integrity Laboratories
  SARS-CoV-2 Assay
PCR
LDT
N/A
N/A
FDA EUA
View Source
   Baptist Hospital Miami
  SARS-CoV-2 Test
PCR
LDT
N/A
N/A
FDA EUA
View Source
 Orig3n, Inc.
Orig3n 2019 Novel Coronavirus (COVID-19) Test
PCR
LDT
N/A
N/A
FDA EUA
View Source
 Rutgers Clinical Genomics Laboratory-Rutgers University
 SARS-CoV-2 Assay
PCR
LDT
N/A
N/A
FDA EUA
View Source
 Specialty Diagnostic (SDI) Laboratories
SDI SARS-CoV-2 Assay
PCR
LDT
N/A
N/A
FDA EUA
View Source
 University of North Carolina Medical Center
 UNC Health SARS-CoV-2 real-time RT-PCR test
PCR
LDT
N/A
N/A
FDA EUA
View Source
Sentenial Diagnostics
STAT NAT COVID Test
PCR
LDT
N/A
N/A
CE Mark
View Source
Shanghai Fosun Long March Medical
Shanghai Fosun Test
PCR
Lab-Based
N/A
N/A
CE mark
View Source

 

Recent Developments

 

Antibody testing role to be determined

The use of antibody testing is often mentioned as an important part of the process. These tests, which are generally cheaper, faster, and more portable than molecular tests, are less useful for diagnostics but can determine past exposure. While they could possibly be very important for certain purposes, depending on other factors, it’s possible that their impact could be minimal with respect to stopping COVID-19’s spread.

The first necessary step is to perform broad antibody screening to determine, with statistical confidence, the prevalence of the disease in the population, which will inform the future decisions about further large-scale screening. In fact, the results of this large-scale “first pass” of the population will determine the usefulness and requirements of antibody testing as a whole; if less than 5% of the population has been exposed, an antibody test with 95% specificity (5% false positives) provides information that is no better than a coin toss.

Shortages and capacity limitations still hinder labs

There has been moderate success thus far in addressing the shortages that have slowed testing. Supplies are gradually ramping up. But many labs are still having difficulty obtaining upstream products like nasal swabs, sample tubes, RNA extraction kits, transport media, and the personal protective equipment (PPE) needed for the sample collection procedure.

As a result, labs are generally running well below their potential capacity. The situation is worse for smaller labs with limited instrumentation, as better-equipped labs are able to “hedge” and switch between different types of systems as needed depending on changes in the availability of supplies.

Creative solutions for lab shortages

Shortages of testing-related products have combined with the inherently constrained capacity of diagnostic labs to create major challenges for scaling up. Until recently, there was a large backlog of samples in many parts of the country. But clinical labs and research labs have been coming up with some creative solutions to address these limitations.

One example is pooling, which involves the mixing of individual samples into “pools” which are then run on the instrument. This concept has already been applied to the screening of samples in diverse settings for some time. When a pool gets a positive result, the individual samples in that pool will all be run to determine which are positive. A pool with a negative result allows those samples to be skipped. Despite some samples being run on the system twice as a result, this can increase the efficiency of testing two- to fivefold depending on the protocol.

Typically, the pools consist of five to 20 samples, but the number depends on the rate of positive tests. Pooling only provides a benefit if the positive cases make up a low percentage of the total. As the rate of positive results goes higher than 5% and approaches 10%, the efficiency of this approach drops to that of running individual samples.

The most straightforward approach to pooling is simply to split the samples into groups of five or 10, with each sample going into one pool. For a batch of 1,000 samples with five per pool, a first round of 200 pools would be run on the instrument. As some pools are determined to be positive, their component samples are re-pooled by halving the groups and then run again. Pools that give negative results can be completely disregarded, saving instrument time. This design can result in a more than 50% reduction in run-time.

There are also more intricate approaches to pooling that provide further efficiency increases. For example, techniques have been described whereby replicates of the samples are split into multiple pools instead of just one. Algorithms determine how to test the positive pools. These modifications have allowed an efficiency increase of fivefold compared to running individual samples. The U.S. Food and Drug Administration (FDA) has given permission to individual labs to modify their protocols to combine five samples per pool as long as the overall positive test rate of the samples remains below 10%.

Most of the COVID-19 tests have been run using oropharyngeal (OP) and nasopharyngeal (NP) swabs. This type of sampling is typically unpleasant for the patient, can be physically challenging (particularly for younger patients), presents risks for the healthcare professional, and consumes PPE.

These factors, combined with the shortage of swabs, transport medium, and PPE, have driven the exploration of other ways to collect samples. One example is the use of saliva samples. Rutgers Clinical Genomics Laboratory received the first emergency use authorization (EUA) from the FDA to run COVID-19 tests on saliva samples. Per the EUA, saliva specimens must be collected in a healthcare setting under the supervision of a trained healthcare provider using a Spectrum Solutions SDNA-1000 saliva collection device.

Another aspect of the solutions being developed to address the capacity and supply issues is the use of RNA extraction-free protocols. Most COVID-19 testing involves a sample preparation step which includes the release and isolation of RNA from the sample matrix. This process can be time-consuming, sometimes taking longer than the reverse transcription polymerase chain reaction (RT-PCR) step.

Some labs have found that it is possible to obtain reliable results without doing RNA extraction; this appears to be less successful when there is a low amount of virus present, which may correspond to milder symptoms. However, the modification of protocols in this manner must be consistent with FDA guidelines regarding EUA.

Mayo Study Warns on PCR False Negatives; Suggests Combo Tests

Are healthcare providers and the public putting too much faith in the accuracy of diagnostic tests for COVID-19? An article published April 9 in Mayo Clinic Proceedings warns that a second wave of novel coronavirus infections could occur among individuals who believe they are in the clear because their COVID-19 test was negative.
In the article, the authors maintain that the sensitivity and other aspects of reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 have not been clearly reported. RT-PCR testing is most useful when tests are positive, but it’s less useful for ruling out infection with SARS-CoV-2, the virus that causes COVID-19. Therefore, a negative RT-PCR test does not mean a person is free of the disease, noted Dr. Priya Sampathkumar of the Mayo Clinic in Rochester, MN, in a release. More in LabPulse.com: https://www.labpulse.com/index.aspx?sec=sup&sub=mic&pag=dis&ItemID=801042

Sensitivity and Specificity – “Right Now it’s a Wild West Show”

First the concern was ‘when will tests be developed,’ now concern is forming on accuracy.  There isn’t enough clinical data in most cases for sensitivity and specificity assessment; just the limited analytical data used for validation.  In this ABC News story –  Eric Blank of the Association for Public Health Laboratories  says “Right now it’s a wild west show out there”  https://abcnews.go.com/Health/wireStory/fears-wild-west-covid-19-blood-tests-hit-70107625.   Kalorama’s take: These concerns will increase now that there is a good volume of PCR vendor tests.  It’s rational to suppose that major players fare better such as Roche, Hologic, Simemns, BD, BioFire, Cepheid and Abbott are better set up to provide high quality testing.  High installed bases will generate feedback loops that should fuel product improvements; new tests won’t benefit from that immediately.  That being said, with the speed of development tests, specificity/sensitivity is unlikely to be at the same level as clinically battle-tested flu or hepatitis tests.

Qiagen reports increased earnings on COVID-19 Testing, But Don’t Expect All DX Companies to Fare This Way

Many DX companies will have poor Q1s but not molecular giant Qiagen, in the process of its acquisition by Thermo Fisher.  For the three months ended March 31, 2020, Qiagen reported preliminary revenue growth of 9 percent at constant exchange rates.  This comes as Quest reported being down 40% in volume for the quarter and Thermo Fisher reported a poor last two weeks of March.

Coronavirus Response Crowding Resources for Other Diseases?

With a focus on COVID-19 and an expected increase in cases in the developing world, diseases such as measles may be receiving less resources.  There’s also an uptick in an otherwise resolving Ebola crisis in the Democratic Republic of the Congo.  Per Nature: “The coronavirus pandemic has dealt measles-control efforts another huge blow. On 26 March, SAGE recommended that countries temporarily suspend all preventive mass-vaccination campaigns, including those for measles. Already, 23 countries have suspended scheduled measles campaigns, and others will probably follow suit, … This means that 78 million children will not be vaccinated as planned, he says. The DRC, however, is continuing its outbreak response.” https://www.nature.com/articles/d41586-020-01011-6

Other Developments:

  • Inflatable Biosafety Lab for COVID-19 Developed:  BGI, in collaboration with the company Etopia, have jointly designed a mobile, inflatable P2 level biosafety laboratory: the “Huo-Yan Air Lab.”(meaning “Fire Eye”) Air Lab uses a modular air dome structure. It can be easily transported by air as standard freight on any commercial passenger plane, and quickly constructed and deployed locally to support the screening and detection capabilities of countries around the world, thereby allowing authorities to control the pandemic at an earlier stage.  Huo-Yan is based on BGI’s previous experience during the Ebola outbreak in 2014 in West Africa.
  • China Clamps Down on COVID-19 Diagnostic Testing Kit Exports: Worried about reptuation abroad of tests made in China, the nation is stepping up enforcement and scrutiny of exported tests in the wake of improved condtions. – According to the New York Times https://www.nytimes.com/reuters/2020/04/01/world/europe/01reuters-health-coronavirus-china-testkits.html is stepping up its oversight of exports of coronavirus test kits.   Chinese exporters of coronavirus tests must now obtain a registration certificate from the National Medical Products Administration (NMPA) in order to be cleared by China’s customs. The country had encouraged Chinese firms to export test kits and other supplies to help battle the coronavirus pandemic, leading to a surge of companies offering kits to countries.  Spain returned rapid diagnostics manufactured by Chinese diagnostics firm Shenzhen Bioeasy Biotechnology after the product was found to have very low accuracy (the company said test operator error was to blame). The NY Times said that Slovak government officials had questioned accuracy of rapid tests purchased from China.
  • Use Research Labs?  An article in LabPulse.com suggests using research labs might be a way to solve the capacity crisis:  https://www.labpulse.com/index.aspx?sec=sup&sub=mic&pag=dis&ItemID=801024 
  • Eurofins and OrthoClincal Diagnostics announced joint plans to develop a high-throughput anti-body test. https://www.fiercebiotech.com/medtech/ortho-eurofins-lay-out-plans-for-high-throughput-covid-19-antibody-blood-testing  from Fierce: “This would allow centralized, lab-based diagnostic hardware to process blood samples at scale, screening patients for previous infections and possible immunity in volumes similar to how molecular testing machines check swabs for active signs of the novel coronavirus.”
  • They join 70 other developers who have notified FDA –  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-
  • Handheld Test Ships: Mesa Biotech announced it is shipping 10,000 of its handheld Accula SARS-CoV-2 molecular rapid point of care (POC) tests this week. The company’s COVID-19 test uses patented technology to enable ‘near patient’ testing outside of the central laboratory with diagnostic results in 30 minutes.
  • Federal Watchdog Blames Lack of Testing: A recent report from the Office of the Inspector General pins the lack of testing as a factor in the severity of the outbreak by limiting hospital containment, patient isolation and resource allocation of masks and PPE   “Hospitals reported that severe shortages of testing supplies and extended waits for test results limited hospitals’ ability to monitor the health of patients and staff. Hospitals reported that they were unable to keep up with COVID-19 testing demands because they lacked complete kits and/or the individual components and supplies needed to complete tests. Additionally, hospitals reported frequently waiting 7 days or longer for test results. When patient stays were extended while awaiting COVID-19 diagnostic test results, this strained bed availability, personal protective equipment (PPE) supplies, and staffing.” https://oig.hhs.gov/oei/reports/oei-06-20-00300.pdf
  • Detection is Only One Component of Testing:  Blood gas testing is often required for ventilator-assisted patients and those undergoing evaluation for respiratory distress, providing insights into a patient’s oxygenation level. Siemens Healthineers announced a new RAPIDPoint 500e Blood Gas Analyzer he RAPIDPoint 500e Blood   gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation, providing the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required. Abbott’s iSTAT is a market leader in rapid blood gas testing.  d-Dimer has been cited as a factor in coronavirus survival in a Lancet study: d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage.  https://www.ncbi.nlm.nih.gov/pubmed/32166607  The study also cites C-Reactive protein (CRP) as a risk factor.  In high levels CRP has been associated in negative outcomes in studies of COVID-19 patients in China. https://www.medrxiv.org/content/10.1101/2020.02.23.20026963v1 and https://www.ncbi.nlm.nih.gov/pubmed/32166607  
  • Throughput Arrives: On the large-scale test side, the impact of models like the Roche cobas 6600 or the Abbott m2000 can be seen in the increased testing at major labs.  Commercial labs such as LabCorp and Quest — and some hospitals and academic medical centers — have been making their own tests available and are ramping up testing capacity quickly. Quest said it is now conducting 25,000 tests per day in the U.S., which it plans to expand to 30,000 by the end of this week.  At the same time, Cepheid has shipped POC tests.  Time will tell the impact of those in the field, but we’d expect increased case numbers as these systems can be available where a provider and patient is and provide a 45 minute result.  No special operator training is required.  NeuMoDx™ SARS-CoV-2 Assay, the NeuMoDx Systems integrate the entire process of testing for SARS-CoV-2 – from specimen lysis through detection or ‘sample to result” – and provide operators with the ability to load up to 288 patient samples in a continuous, random-access workflow resulting in on-demand, high throughput testing. Additionally, the NeuMoDx Systems allow laboratories to efficiently validate their own SARS-Cov-2 Laboratory Developed Tests, including those provided by WHO and the CDC, in order to immediately improve throughput and increase the volume of testing.
  • Abbott’s IDNOW test approval for its own mPOC no special training system just occurred and is welcome as well.  The system benefits from its thousands of placements globally.  (Media reports say 18,000 in the U.S. but Abbott has not said that directly in a press release or to us).  It was previously Alere’s system, which Abbott acquired in 2017.  Both it and Cepheid have international placements, which will help if and when there are large developing world case loads.
  • Qiagen’s Syndromic Panel: Netherlands-based Qiagen announced on March 24 that it had begun shipping QIAstat-Dx SARS-CoV-2 test kits to the United States under a new FDA Policy allowing the kits to be made commercially available. Now, QIAGEN received U.S. FDA EUA for QIAstat-Dx test kit, first and only syndromic solution integrating detection of SARS-CoV-2 coronavirus. The test can differentiate novel coronavirus from 20 other serious respiratory infections. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories.
  • Immunoassays: We are at the beginning of the launch of serological tests.  Finding antibodies in the patient which signal disease is one of the oldest test technologies and still very present in the laboratory in 2020.  Their advantage is they are cheap and easy to scale testing.  But they are hard to develop and can be less accurate than molecular testing.  Immunoassays take long to develop because require modeling of antibodies to detect for COVID-19.  (Though that work is not wasted -there’s some evidence they can help vaccine manufacture too, a useful side benefit. ) Right now there is some secondary action with these tests, such as using them to decide if PCR testing is needed, or using them where no other option exists.  Eventually, Kalorama expects immunoassays to be developed and to take over as routine tests.  For a crisis, PCR seems logical.  Major POC immunoassay players include Sekisui Diagnostics, Becton Dickinson, and Quidel.
  • Ancillary/Secondary COVID-19 Tests: At least one immunoassay is seeing usage, though not for direct detection of the disease.  Bio-Techne Corporation said their ProteinSimple™-branded Ella™ Automated Immunoassay platform  is being used to detect Cytokine Release Syndrome (CRS) in real-time. Cytokine Release Syndrome represents a critical point in individuals with severe COVID-19 disease where immune molecules, called cytokines, attack the patient’s organs, representing a critical and potentially fatal point in disease management. The test results are available in a few hours and can be repeated throughout the course of care to help guide hospital care and to measure the response to experimental drugs given in clinical trials for COVID-19 patients.  Another firm, BioMedomics, Inc., a small research and development firm in Research Triangle Park, created one of the world’s first rapid tests to assist in the detection of COVID-19, the disease caused by the novel coronavirus.  The test only requires a small blood sample and can deliver results within 15 minutes.   The company is encouraging its use as a first-line test, to decide if testing is necessary.

Congress Passes CARES Act

The U.S. Senate has passed a $2.2 trillion spending bill — dubbed the CARES Act — designed to provide economic stimulus and fund the effort to combat the SARS-CoV-2/COVID-19 epidemic in the U.S.  There will be a great deal of attention on small business loans and checks to American taxpayers, but the bill also contains provisions of interest to laboratories and IVD companies.

Among the provisions: Health plans cannot pass off costs to consumers outside of their normal premiums. Group health plan or health insurers must cover COVID-19 testing (Section 3717) without imposing cost sharing such as deductibles, co-payments, and coinsurance. Prior authorization requirements on COVID-19 diagnostics are banned during the emergency period.  Unlike prior legislation, the CARES Act not only applies to tests that received 510(k) clearance but also includes tests being prepared for emergency use authorization from the FDA.  Or those being prepared for state authorities.

South Korean Firm Blends AI and Portable X-Ray Testing to Power Up  COVID-19 PCR

South Korean Firm JLK Inspection Inc. has added another dimension to RT-PCR testing for COVID-19 with AI and imaging enhanced diagnostic aids.   The company’s product is its AI Total COVID-19 Care based on its AIHuB. AIHuB conducts analysis from MRI, CT, X-ray and mammography imagery with an AI-enabled technology that encompasses a wide variety of diagnostic techniques to pinpoint illnesses such as stroke, Alzheimer’s and cancer. This has been applied to COVID-19 in South Korea, where JLK has connected their system to an RT-PCR test. The company’s AI Total COVID-19 Care is comprised of three products, including AI Software that triages the pneumonia patients develop, a PCR test and a portable X-ray

Challenges

Test Equipment and Worker PPE Remain an issue

Testing cannot fully be brought to bear without proper protection for those operating the tests and collecting the samples.  Supplies of PPE will be a challenge for laboratories and healthcare workers, and could limit test volume.  Some supplies such as COVD-19 reagents or RNA sample extraction kits remain challenging for test makers, even  where innovative instruments are daily appearing on the scene.

JAMA Network Calls for Creative ideas for Increasing PPE Suppl

Orders for standard/disposable masks are on long back-orders, due to both demand and supply chain issues. Other hospitals across the country are reporting the same supply concerns. A recent JAMA Network article soliciting suggestions for PPE is at over 200 comments:

  • Many suggestions advising using ultraviolet light towers to irradiate high numbers of masks, which were originally designed to only be used once.
  • While fabric masks are not to be used in the care of COVID-19 patients, according to the CDC, fabric masks are a crisis response option when other supplies have been exhausted.  Fabric masks can also be helpful in other areas of patient care as supplies of PPE are depleted. Deaconess Medical Center has a video dedicated to the making of masks: https://youtu.be/9tBg0Os5FWQ
  • Many suggestions that dentists donate extra masks. One commenter estimated in Maryland alone, there are about 1000 surgical masks in stock (about 2 weeks worth). According to my research there are about 2,500 dental practices in Maryland. which would mean 2.5 million masks, of which a large portion may no longer be needed due to dentists cancelling elective appointments.
  • A simple “Aerosol Box,” made of clear plastic which helps physicians perform endotracheal intubations, was created by Lai Hsien-yung , an anesthesiologist with Mennonite Christian Hospital in Hualien, Taiwan.
  • Other suggestions including using plastic walls or even plastic curtains like those used in construction or renovation could be used to isolate part of patient rooms. These would allow for eyeballing and IV lines could go from the patient part of the room to outside.
  • Using adapted snorkel masks as PPE were the suggestion of more than a few commenters, and they were completely serious.  One suggested hospitals “Combine “full face” diving masks with 3D printing to adapt the snorkel area with a p100 filter, using 1 instead of the usual 2 filters. These have a good sealing and should be relatively low cost; the filter should be good enough for 1 month, and the mask should be easy to clean.”

SARS-CoV-2 Replication in Upper Respiratory Track Seen as Culprit

Why is this infectious disease threat more daily than influenza, Ebola, Zika or West Nile?  The newness of the infection strain and the means of viral replication may be one of many culprits.  Per the New England Journal of Medicine: “The efficiency of transmission for any respiratory virus has important implications for containment and mitigation strategies. The current study indicates an estimated basic reproduction number (R0) of 2.2, which means that, on average, each infected person spreads the infection to an additional two persons. “

This seems to be due to the heavy and actively replicating presence of virus in the upper respiratory track. More: “Recent reports of high titers of virus in the oropharynx early in the course of disease arouse concern about increased infectivity during the period of minimal symptoms.”

Patients May Continue to Shed Virus After Symptom Clearance

Patients may continue to shed the virus that causes COVID-19 according to a study published online March 23 in the American Thoracic Society’s (ATS) American Journal of Respiratory and Critical Care Medicine. Researchers found that patients treated for mild COVID-19 still had the virus for up to eight days after symptoms resolved — a result that underscores the difficulty of curbing the disease. Their study provides “initial insights” into the ability of the virus to persist even after the resolution of [symptoms] for as long as eight days, which may pose a significant challenge in controlling the spread of the disease. The COVID-19 pandemic is the “third and the most lethal outbreak of coronavirus in the 21st century,” the artcile noted, and its ability to spread appears to arise from transmission from asymptomatic patients. “Cases have been reported where a patient could infect their close contacts even after ‘apparent recovery’ from the infection,” the authors wrote. “This warrants [investigation into] the ‘shedding window’ after the clinical recovery of the patient.” The study sought to investigate the time frame of “viral clearance” as it related to the resolution of COVID-19 symptoms. Their study included 16 patients (median age, 35 years) who were treated for the disease and released from the hospital between January 28 and February 9. The time from infection to the onset of symptoms was five days for all patients except one, and the average duration of symptoms was eight days.

Viral Load/ Symptom Connection: Conflicting Studies

The issue of COVID-19 viral load and severity of illness. has been looked at but not sufficiently answered https://www.newscientist.com/article/2238819-does-a-high-viral-load-or-infectious-dose-make-covid-19-worse/ For instance, health workers investigating the covid-19 outbreak in the Lombardy region of Italy looked at more than 5,000 infected people and found no difference in viral load between those with symptoms and those without. They reached this conclusion after tracing people who had been in contact with someone known to be infected with the coronavirus and testing them to see if they were also infected. Similarly, when doctors at the Guangzhou Eighth People’s Hospital in China took repeated throat swabs from 94 covid-19 patients, starting on the day they became ill and finishing when they cleared the virus, they found no obvious difference in viral load between milder cases and those who developed more severe symptoms.  Although it is difficult to draw firm conclusions at this stage, such studies “may impact our assumptions about whether a high number of viral particles predisposes to a more serious disease”, says van Schaik. For influenza, a higher infectious dose has been associated with worse symptoms. It has been tested by exposing volunteers to escalating doses of influenza virus in a controlled setting and carefully monitoring them over several weeks. This hasn’t been done with covid-19, and is unlikely to happen, given its severity.

Full Weight of mPOC Yet to Be Brought to Bear

In point of care PCR there are approvals, but with caveats that it will take time to deliver systems.  There are now molecular point-of-care approvals with BioFire and Cepheid and Abbott.   But it’s still the logical answer.  Molecular Point of Care (mPOC), which analyze DNA or RNA, typically using polymerase chain reaction (PCR) technology or another form of nucleic acid amplification, make all the sense in the world where you have to know quickly if a patient has COVID-19, where there are carriers without symptoms, and where patients should be isolated.  They make even more sense where there is a potential non-patient population that may wish to know if they’ve been exposed.

Credo Diagnostics Biomedical: VitaPCR platform, COVID-19 assay received a CE Mark. Oxford Nanopore Technologies is another player, having announced in January that it had shipped hundreds of its MinION units, which are portable devices for real-time DNA and RNA sequencing, and related consumables to China, the center of the novel coronavirus outbreak.  Ubiquitome is planning to develop a coronavirus test on its Liberty16, a mobile, real-time PCR system with two to three hours of battery life.

Other companies that are developing or have developed mPOC tests for SARS-CoV-2/COVID-19 include the following:

  • Diagnostics for the Real World: SAMBA II COVID-19 test
  • HiberGene Diagnostics: HG Swift (can use battery power), COVID-19 assay based on loop-mediated isothermal amplification (LAMP)
  • Molbio Diagnostics: Truelab, Truenat SARS-CoV-2, Trueprep, and Truenat instruments
  • Mobidiag: Novodiag COVID-19 + influenza A/B, multiplex test
  • Qiagen: QIAstat-Dx Respiratory 2019-nCoV test
  • QuantuMDx: Q-POC, handheld

The number of labs in the U.S. that are qualified for CLIA high-complexity testing is on the order of 10,000 to 11,000. Based on experience with influenza, which is similar in some respects, the number of tests that are needed for coronavirus will likely rise to tens or even hundreds of thousands per week.

The overlap of symptoms with flu could create a need to rapidly scale up testing to differentiate these cases from coronavirus. Some companies such as Cepheid and Mobidiag are developing multiplex panels for flu and coronavirus to better distinguish the diseases.

Will We See Fundamental Change in IVD?

This is a worthwhile question.  It’s possible diagnostics will not be the same after this crisis in so many ways, though Kalorama can only comment on the IVD market landscape and to a limited degree the vaccine landscape.  It’s useful to point out as a counter to any notion of massive change in the future that the healthcare systems of the world have seen many diseases temporarily get attention, only to lose that attention when the immediate problem is cured, or when there is some other large-scale threat.

That being said, we’d expect some deep thinking about the pace of test approval in the coming months.  The contrast of effective [though still to be measured] Chinese and Korean testing, and other CE Marked test employed in Europe versus the slow rollout of testing in the United States will be an unavoidable one in policy discussions.   This added to the CDC’s snafu in kit delivery , its insistence on commercialization and in waiting on approval of LDTs, would make a powerful argument for reform.

This from the New England Journal.

“This crisis is a stark reminder of the ongoing challenge of emerging and reemerging infectious pathogens and the need for constant surveillance, prompt diagnosis, and robust research to understand the basic biology of new organisms and our susceptibilities to them, as well as to develop effective countermeasures.”

On the spending side, there is already spending for stockpiling and test development in the CARES act and we’d expect that to continue and some continued thought given to building diagnostics innovation long-term.    It’s reasonable to predict that IVDs move from their current status as rationed costs to getting closer to reaching the “first-line” status in healthcare they’ve been seeking.

It would be presumptive to estimate market effects until the true amount of testing revenues by major firms are seen.   Significant costs were likely expended in R&D at major firms during the crisis, and resources devoted to test development.

As a very basic measure – it’s not unusual for Kalorama or other analysts to find flu testing companies grow 10% to 20% during a particularly menacing flu season.  This provides a floor for the type of revenue increase companies will have during this to-be-completed quarter, but not a ceiling.