NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

SEROLOGY

Business Genre:
Business Description:

A global healthcare company with marketing more than 160 countries. They focus on the area in diabetes, diagnostics, nutritients, neuromodulation. [1]

City:
Abbott Park
State:
IL
Country:
USA
Data/Evidence of Effectiveness:
Urgent care studies showed >94.7 % positive agreement (sensitivity) and >98.6 % negative agreement (specificity) with lab-based PCR methods to detect CoV-2 virus. [4]
Complimentary Products Needed to Perform Test:
An instrument-based isothermal test. Need the ID NOW Instrument, sample receiver, elution/lysis buffer, and a test base [3]
Setting of Care:
Authorized laboratories – laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high and moderate complexity tests. Other Authorized Testing Locations – patient care settings using the ID NOW Instrument. [2]
Current Status / Clinical Development Stage / Expected Milestones:
Authorized under EAU. Waive current good manufacturing practice requirements under EAU. For in vitro diagnostics only. [2]
LOD:
125 [4]
Funding & Ownership :
Public (Market Cap $158.5B) [6-7]
Business Model:
Sell various medical products related to diabetes, cardiovascular, diagnostics, neuromodulation, nutrition, pharmatheuticals [1]
IP:
N/A
History & Origins :
Company with extensive experience in numeral area in biotechnology, including diagnostics. [1]
Date EUA Issued:
03/27/2020 [2]
Sources:
“[1] https://www.abbott.com/ [2] https://www.fda.gov/media/136522/download [3] https://www.fda.gov/media/136522/download (IFU) [4] https://abbott.mediaroom.com/2020-05-21-Abbott-Releases-Interim-Clinical-Study-Data-on-ID-NOW-COVID-19-Rapid-Test-Showing-Strong-Agreement-to-Lab-Based-Molecular-PCR-Tests [5] [6] https://www.crunchbase.com/organization/abbott [7] https://finance.yahoo.com/quote/ABT/ [8] https://www.abbott.com/corpnewsroom/utilities/executive-team.html”
Organization:
Robert B. Ford (CEO), John Ginascol, Andrea Wainer, Jaime Contreras, Christopher Scoggins (VP for Diagnostics) [8]
No. Tests Per Day:
single test can be done in 13 mins, roughly 6 per hours, that would be 144 per day
Time to Result:
13 minutes or less [3]
Test Sample Type:
Throat swab, nasal swab, nasopharyngeal swab [3]
Technology Overview:
Ultilize isothermal nucleic acid amplification technology to detect the CoV-2 virus RNA in the sample [3]
Testing Type:
Qualitative viral RNA test [3]
Test Category:
SEROLOGY
Test Name:
ID NOW COVID-19
Clinical Application & Need:
acute infection [2]
Age of Company:
1888
Business Genre:
Business Description:

global healthcare company in over 160 countries, product portfolio focuses on diagnostics, medical devices, generic medicines, and nutritionals [1]

City:
Abbott Park
State:
IL
Country:
USA
Data/Evidence of Effectiveness:
Many claims in health care provider fact sheet that false positive and false negatives may occur [4]. Control and calibration samples are available to increase robustness of test [3]. U of Washington published in J Clin Microbiol that test had “99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptom began.” [5]
Complimentary Products Needed to Perform Test:
serum separator tube (serum) or lithium heparin in separator tube (plasma) and ARCHITECT i1000SR or i2000SR systems (Abbott instruments) [3], SARS-CoV-2 IgG calibrator and control kit (sold separately), instructions available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Setting of Care:
authorizied laboratories (required to report results to healthcare providers and public health authorities) [3]
Current Status / Clinical Development Stage / Expected Milestones:
NOT FDA cleared/approved; FDA approved to meet EUA criteria [3]. Under EUA, cGMP requirements have been waived [3]; for in vitro diagnostic use ONLY [3]; currently available for purchase [2]
Funding & Ownership :
Public (Market Cap $158.5B) [7]
Business Model:
sale of medical products focused on cardiovascular, diabetes care, neuromodulation, nutrition, and diagnostics and consumer products including some popular brands such as ENSURE protein drinks, ZONEPERFECT bars, PEDIALYTE and PEDIASURE [1]
IP:
N/A
History & Origins :
Company has extensive experience in creating diagnostic tests. Previous focus includes immunosassays, hematology assays, photometric and potentiometric assays. [1]
Date EUA Issued:
4/26/2020 [3]
Sources:
[1] https://www.abbott.com/; [2] https://www.corelaboratory.abbott/us/en/offerings/segments/infectious-disease/sars-cov-2; [3] https://www.fda.gov/media/137384/download; [4] https://www.corelaboratory.abbott/sal/faq/SARS-CoV-2IgGEUARecipientFactSheet.pdf; [5] https://jcm.asm.org/content/early/2020/05/07/JCM.00941-20; [6] https://www.abbott.com/corpnewsroom/utilities/executive-team.html [7] https://finance.yahoo.com/quote/ABT/
Organization:
Robert B. Ford (President/CEO); Miles D. White (Executive Chairman); Executive VPs for diagnostics (John Ginascol, Andrea Wainer, Jaime Contreras, Christopher Scoggins) [6]
Time to Result:
29 minutes for 1 result; 4000 results in 24hr [2]
Test Sample Type:
serum or plasma [3]
Technology Overview:
detects adaptive immune response using a two-step immunoassay using chemiluminescent microparticle immunoassay (CMIA) technology [2-3]
Testing Type:
qualitative IgG antibody test [3]
Test Category:
SEROLOGY
Test Name:
SARS-CoV-2- IgG assay [2]
Clinical Application & Need:
detect current, recent, or prior infection [3]
Business Genre:
Business Description:

They provide top-quality monoclonal antibodies through novel immunization and unique cloning methods using phage display technology [1]

City:
San Diego
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
N/A
Complimentary Products Needed to Perform Test:
N/A
Setting of Care:
Should be in the clinical lab setting
Current Status / Clinical Development Stage / Expected Milestones:
Still in development
Funding & Ownership :
Private, Revenue: less than 1 M [3]
Business Model:
They sell the antibody products and also help customers develop their own antibody [1]
IP:
N/A
History & Origins :
Found in 2012 to address the antibody qualitiy issue. They have patent in their antibody producing methods. [4]
Date EUA Issued:
In development
Sources:
“[1] https://www.abwizbio.com/wizamp [2] https://www.abwizbio.com/the-abwiz-team/covid-19/ [3] https://www.crunchbase.com/organization/abwiz-bio#section-overview [4] https://www.abwizbio.com/the-abwiz-team/”
Organization:
CJ Okumura (CEO), Toshi Maruyama (CSO)
Time to Result:
N/A
Test Sample Type:
should be blood sample
Technology Overview:
Utlilize the rabbit immunizations to create antibodies. For diagnostic use, they are targeting the nucleoprotein (NP) of SARS-CoV-2 [2]
Testing Type:
monoclonocal antibody [2]
Test Category:
SEROLOGY
Test Name:
RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit
Clinical Application & Need:
immunity and futher therapeutics [2]
Age of Company:
2012
Business Genre:
Business Description:

Focus on penetration and improvement of medical laboratory technology,serving for human health” and strives to provide both cost-efficient and high-quality products to medical laboratories [1]

State:
Zhengzhou
Country:
China
Data/Evidence of Effectiveness:
Early onset with poor sensitivity, infection > 15 days: 95.07 % positive agreement [3]
Complimentary Products Needed to Perform Test:
“Sample dilutent, Cassette, alcohol swabs, centrifuge, sample collection containers [3]”
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests [2]
Current Status / Clinical Development Stage / Expected Milestones:
Received EUA approval, ready for purchase
Funding & Ownership :
Public [5], Cap 65.882 B [6]
Business Model:
They sell instruments and kits related to immunoassay and microbiology [4]
IP:
N/A
History & Origins :
Founded in 1998, Autobio has been focusing on the common development of both reagents and instruments. Product catalogue covers many IVD fields, including Immunoassay, Biochemistry, Microbiology, which can provide medical laboratories with comprehensive solutions and service. [1]
Date EUA Issued:
04/24/2020 [2]
Sources:
“[1] http://www.autobio.com.cn/en/index.php?m=content&c=index&a=lists&catid=15 [2] https://www.fda.gov/media/137364/download [3] https://www.fda.gov/media/137367/download [4] http://www.autobio.com.cn/en/index.php?m=content&c=index&a=lists&catid=10 [5] https://www.crunchbase.com/organization/autobio-diagnostics#section-overview [6] https://finance.yahoo.com/quote/603658.SS?p=603658.SS&.tsrc=fin-srch [7] https://www.bloomberg.com/profile/person/18889490”
Organization:
Yongjun Miao (Chairman) [7]
No. Tests Per Day:
serology strip, > 2000/day
Time to Result:
15 to 20 minutes [3]
Test Sample Type:
human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum [2]
Technology Overview:
Test membrane are precoated with two mouse anti-human monoclonal antibodies (anti-IgG and anti-IgM) on two separated test lines. SARS-CoV-2 recombinant spike protein antigen reagents which can specifically bind toSARS-CoV-2 antibodies (IgM and/or IgG), are bound to colloidal gold and sprayed on conjugation pads. The labeled gold colorimetric reagent is used to form a visible red/pink line. [3]
Testing Type:
serology IgG/ IgM [3]
Test Category:
SEROLOGY
Test Name:
Anti-SARS-CoV-2 Rapid Test
Clinical Application & Need:
Immune response to SARS-CoV-2, indicating recent or prior infection [2]
Age of Company:
1998
Business Genre:
Business Description:

Bio-Rad develops products for life science research and clinical diagnostic markets. The company serves university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality [3]

City:
Hercules
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
“Serum: The Platelia SARS-CoV-2 Total Ab assay showed 100% (27/27) positive percent agreement (95% CI: 98.72- 99.85%) in 27 PCR positive subjects and 99.51% (609/612) negative percent agreement [1] (95% CI: 98.58 – 99.83%) in 612 negative subjects. Plasma: The Platelia SARS-CoV-2 Total Ab assay showed 83.3% (20/24) positive percent agreement (95% CI: 64.15 – 93.32%) in 24 PCR positive subjects and 100% (75/75) negative percent agreement (95% CI: 95.13 – 100%) in 75 negative subjects [1] CI: Confidence Interval “
Complimentary Products Needed to Perform Test:
“1. Sterile distilled or deionized water to dilute the concentrated washing solution 2. Sodium hypochlorite (household bleach) and sodium bicarbonate 3. Absorbent paper 4. Adhesive film 5. Gloves and eye / face protection 6. Disposable tubes 7. Precision pipettes or a multipipettor to measure and dispense 10 µL to 1000 µL, 1 mL, 2 mL and 10 mL 8. Graduated cylinders of 25 mL, 50 mL, 100 mL and 1000 mL capacity 9. Microplate washing system 10.Dry-heat incubator, capable of maintaining 37°C ± 2°C 11.Microplate reader equipped with 450 and 620 nm filters 12.Container for biohazardous waste. [1]”
Setting of Care:
Research laboratories [1]
Current Status / Clinical Development Stage / Expected Milestones:
Authorized under Emergency Use Authorization (EUA) granted 4/29/20 [2]. For in vitro diagnotstic use only [1].
Funding & Ownership :
Public [8] First IPO in 1966 [7] net worth as of May 19, 2020 is $13.75B [9].
Business Model:
They provide instruments, software, consumables, reagents, and content for the areas of cell biology, gene expression, protein purification, protein quantitation, drug discovery and manufacture, food safety, and science education. Products and solutions are based on technologies to separate, purify, identify, analyze, and amplify biological materials such as antibodies, proteins, nucleic acids, cells, and bacteria. They are a leading global provider of in-vitro diagnostics supplies for blood transfusion, diabetes monitoring, autoimmune, and infectious disease testing markets [3].
IP:
N/A
History & Origins :
Bio-Rad Laboratories was founded in 1952 by David Schwartz and his wife Alice [7]. The company since then, has expanded to produce diagnostic products for research labs to provide clinical information autoimmune diseases, blood tests, infectious diseases, diabetes monitoring, etc. [7].
Date EUA Issued:
4/29/2020 [2]
Sources:
1. https://www.bio-rad.com/webroot/web/pdf/inserts/CDG/en/IFU_72710_04302020_EUA_EN_US.pdf. 2. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 3. https://www.bio-rad.com/en-us/corporate/about-bio-rad?ID=1003. 4. https://www.bio-rad.com/en-us/corporate/corporate-facts?ID=MR8IQU15. 5. https://www.bio-rad.com/en-us/corporate/newsroom?ID=1006 6. https://www.bio-rad.com/en-us/corporate/corporate-officers?ID=MR8IS7E8Z 7. https://www.bio-rad.com/en-us/corporate/our-history?ID=MR8ISY4VY 8. https://www.crunchbase.com/organization/bio-rad-laboratories#section-overview 9. https://www.macrotrends.net/stocks/charts/BIO/bio-rad-laboratories/net-worth
Organization:
“
Norman Schwartz
- Chairman of the Board,
President and Chief Executive Officer [6]
 Andrew Last- 
Executive Vice President,
Chief Operating Officer [6] 
Giovanni Magni
- Executive Vice President,
Chief Strategy Officer [6] 
Ilan Daskal
- Executive Vice President,
Chief Financial Officer [6] 
Timothy S. Ernst
- Executive Vice President,
General Counsel & Secretary [6] 
Mike Crowley- 
Executive Vice President, 
Global Commercial Operations [6] 
Annette Tumolo
- Executive Vice President,
President, Life Science Group [6] 
Dara Wright- 
Executive Vice President,
President, Clinical Diagnostics Group [6] Ronald Hutton- 
Vice President,
Treasurer
 [6] 
Ajit Ramalingam
- Senior Vice President,
Chief Accounting Officer [6]”
No. Tests Per Day:
96 tests/ 90 minutes. So for 24 hours (1440 minutes), (96 x 1440)/90 tests = 1536 tests.
Time to Result:
1 hour 30 mins [1]
Test Sample Type:
Serum or plasma from blood [1]
Technology Overview:
Platelia SARS-CoV-2 Total Ab is a one-step antigen capture format ELISA for qualitative detection of total anti-SARS-CoV-2 nucleocapsid antibodies (IgM/IgA/IgG) in human serum or plasma samples [1].
Testing Type:
Qualitative totaly antibody – IgG, IgA, IgM [1]
Test Category:
SEROLOGY
Test Name:
Platelia SARS-CoV-2 Total Ab [1]
Clinical Application & Need:
The Platelia SARS-CoV-2 Total Ab assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV2, indicating recent or prior infection [1]
Age of Company:
1952 [7]
Business Genre:
Business Description:

A company that deliver fully integrated suite of biological agent identification products, including FilmArray® and RAZOR® EX Systems to detect the viral and bactria infection [1]

City:
Salt Lake City
State:
UT
Country:
USA
Data/Evidence of Effectiveness:
SARS-CoV-2 archived specimens the positive agreement was 98% (48/49) and negative agreement was 100%. [3]
Complimentary Products Needed to Perform Test:
BioFire® FilmArray® System [3]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity or moderate complexity tests. [2]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
160-500 [3]
Funding & Ownership :
Private, Revenue range: 10M – 50M [4]
Business Model:
Sell their multiplex diagnostic systems along with specific kits for infectious diseases. [1]
IP:
Patent for the FilmArray system [5]
History & Origins :
Specialized in molecular diagnostics using multiplex solution. Merge with BioMérieux in 2014. BioDefense is one of the company splitted from the merge and focus on delivering fully integrated suite of biological agent identification products. [1]
Date EUA Issued:
05/01/2020 [2]
Sources:
“[1] https://www.biofiredefense.com/ [2] https://www.fda.gov/media/137580/download [3] https://www.fda.gov/media/137583/download [4] https://www.crunchbase.com/organization/biofire-defense#section-overview [5] https://www.businesswire.com/news/home/20130313006338/en/BioFire-Diagnostics-Announces-Issuance-U.S.-Patent-FilmArray [6] https://www.biofiredefense.com/about-us/ [7] https://www.linkedin.com/in/kirk-ririe-b136b19a/”
Organization:
Kirk Ririe [7]
No. Tests Per Day:
175 samples / day
Time to Result:
about 45 mins [3]
Test Sample Type:
Nasopharyngeal swabs [2]
Technology Overview:
Paired with the BioFire FilmArray system. After loading the sample, all the other steps including nucleic acid extraction and PCR are done automatically. Detect spike protein and membrane protein of the CoV-2. [3]
Testing Type:
Real-time, nested multiplexed PCR using BioFire® FilmArray® System [3]
Test Category:
SEROLOGY
Test Name:
BioFire COVID-19 Test
Clinical Application & Need:
Multiplexed nucleic acid test intended for the simultaneous qualitative detection and differentiation of nucleic acids from multiple respiratory viral and bacterial organisms1 , including nucleic acid from the SARS-CoV-2 virus [2]
Age of Company:
1990
Business Genre:
Business Description:

Bright Line Research offers biomedical product development, multiplex research and in-vitro diagnostic assay development, label-free binding analysis and cell-based assay services, and protein microarray production, testing, and analysis [4].

City:
Pasadena
State:
CA
Country:
USA
Funding & Ownership :
New Startup (0-1M TTM Revenue) [4]
Business Model:
They provide services in biomedical product development, multiplex research and in-vitro diagnostic assay development, label-free binding analysis and cell-based assay services, and protein microarray production, testing, and analysis [1,2,4].
IP:
N/A
History & Origins :
Company is a start up founded in 2011. They focus on biomedical product development, multiplex research and in-vitro diagnostic assay development, label-free binding analysis and cell-based assay services, and protein microarray production, testing, and analysis [1, 4].
Date EUA Issued:
N/A
Sources:
1. http://www.brightlineresearch.com/home.html 2. http://www.brightlineresearch.com/services.html 3. http://www.brightlineresearch.com/sars-cov-2–covid-19–programs.html 4. https://app.scientist.com/providers/brightline-research 5. https://www.scienceexchange.com/labs/bright-line-research
Organization:
David Ralin, Principal [5]
Test Category:
SEROLOGY
Test Name:
Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test
Age of Company:
2011 [1,4]
Business Genre:
Business Description:

Immunoassay development company that merged with Erba Diagnostics Ltd., offering a comprehensive suite of clinical testing products to small hospitals, reference labs, and physician clinics in the developed and emerging markets. CalBiotech specializes in ELISA (Enzyme-Linked Immunosorbent assay) and CLIA (Chemiluminscent Immunoassay Technology) assays and has over 200 products which are distributed to over 80 countries globally [1].

City:
El Cajon
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
58 serum samples collected from previously RT-PCR confirmed COVID-19 patients were tested. 57 of the tests returned a positive result and 1 negative result. 107 Normal healthy patients with samples collected before COVID-19 outbreak (prior to December 2019) were tested. 105 tested negative and 2 tested positive. The diagnostic sensitivity is reported to be 98.3% and diagnostic specificity is 98.1%.No interference was observed with Haemoglobin, Bilirubin, Biotin or IgM [2].
Complimentary Products Needed to Perform Test:
Ready to use reagents supplied in kit [2]. Kit is compatible with any automated ELISA analyzer [4]
Setting of Care:
N/A? Seems like a clinical lab but not specifically stated.
Current Status / Clinical Development Stage / Expected Milestones:
“Notification status by the FDA, under product code QKO. Not FDA approved. Submission number is D386770 [2]. EUA approval pending [4].”
Funding & Ownership :
Company joined the Erba Diagnostics Ltd. group in 2017 [1]. ERBA Diagnostics is a privately owned for profit company. M&A status. Amount undisclosed [5].
Business Model:
They partner with biotech, pharma and CROs and providing contract manufacturing and assay development services. They specialize in ELISA and CLIA assays for human and animal research. [1]
IP:
ErbaLisa for HIV Gen 3 is a third generation ELISA for the detection of total antibodies (IgG, IgM, & IgA) against HIV 1 & 2 [6]. Unsure if the same ErbaLisa patent applies for the COVID-19 IgG test.
History & Origins :
Calbiotech was founded in 1998 [8].The company specializes in immunoassay manufacturing and development for hormones, infectious disease, cancer, autoimmune disorders, etc. They also provide contract manufacturing and custom assay services. In 2017, they joined the Erba Diagnostics Ltd. group, a fully integrated global in vitro diagnostics company, offering a comprehensive suite of clinical testing [1].
Date EUA Issued:
“Notification Status by the FDA, under product code QKO. Submission number is D386770 [2]. EUA following soon [4].”
Sources:
1. https://www.calbiotech.com/about 2. https://erbalisacovid19.erbamannheim.com/ 3. https://www.medicaldevice-network.com/news/erba-mannheim-covid-19-antibody-kits/ 4. https://erbamannheim.com/article/press/211 5. https://www.crunchbase.com/organization/erba-diagnostics-mannheim#section-overview 6. https://transasia.co.in/reagent/blood-banking/erbalisa-hiv-gen-3/208 7. https://www.wsj.com/market-data/quotes/ERBA/company-people/executive-profile/134773084 8. https://www.linkedin.com/company/calbiotech-inc_4/about/
Organization:
“For parent company (ERBA Mannheim) Suresh Hassanand Vazirani (Executive Chairman), David Barkay (Chief Executive Officer), Jean Felix LaCroix, (Treasurer, Chief Financial & Accounting Officer), Nikhil Kumar Suresh Vazirani (Director), Gerald E. Gallwas (Independent Director), David M. Templeton (Independent Director) [7]”
No. Tests Per Day:
96 tests/ 50 minutes. So for 24 hours (1440 minutes), (96 x 1440)/50 tests = 2764.8 tests.
Time to Result:
50 minute incubation time [2]
Test Sample Type:
Serum from blood [2]
Technology Overview:
Detects IgG antibody levels to identify how many people have been infected and may have developed an immunity [3]. Test uses Indirect ELISA using recombinant Spike subunit antigen [2].
Testing Type:
Serum IgG test. Qualitative and semi- quantitative assay [2-4].
Test Category:
SEROLOGY
Test Name:
ErbaLisa COVID-19 IgG [2-4]
Clinical Application & Need:
Detect current or prior exposure to COVID-19 [2-4]
Age of Company:
Calbiotech was founded in 1998 [8]. They joined the Erba Diagnostics Ltd. groupin 2017 [1].
Business Genre:
Business Description:

Cellex Incorporated is a biotechnology company that develops technologies, instruments and assays for testing of human diseases and conditions, particularly at point-of-care (POC) settings [1, 2].

City:
Research Triangle Park
State:
NC
Country:
USA
Data/Evidence of Effectiveness:
” qSARS-CoV-2 IgG/IgM Rapid Test had a Positive Percent Agreement and Negative Percent Agreement of 93.75% (95% CI: 88.06-97.26%) and 96.40% (95% CI: 92.26-97.78%), respectively [6]”
Complimentary Products Needed to Perform Test:
All inclusive kit [6]
Setting of Care:
laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity test [4-6].
Current Status / Clinical Development Stage / Expected Milestones:
FDA EUA approved and available for in vitro diagnostic use only [4-6].
Funding & Ownership :
Private [1]
Business Model:
They can produce purified antigen or monoclonal antibody conjugates to a marker. They have expertise in production of antigens produced either in mammalian or bacterial cells, monoclonal antibodies produced in hybridomas, and viral lysates/virus produced from large-scale cell cultures. A variety of tools are used to purify the antigens, monoclonal antibodies or viruses, including gel filtration chromatography, affinity chromatography, tangential flow filtration, and sucrose gradient ultracentrifugation [2].
IP:
N/A
History & Origins :
Cellex Incorporated is a biotechnology company founded in 2002. They develop technologies, instruments and assays for testing of human diseases and conditions, particularly at point-of-care (POC) settings. Cellex was founded in the state of Maryland. Cellex moved its main operation to the Research Triangle Park (RTP), North Carolina, USA, where its main R&D staff is located. They also have a manufacturing facility [1, 2].
Date EUA Issued:
4/1/2020 [4]
Sources:
1. https://www.linkedin.com/company/cellex-incorporated/about/ 2. http://www.cellex.us/About/?1-1.html 3. https://cellexcovid.com/ 4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization 5. https://www.evaluate.com/vantage/articles/news/policy-and-regulation/fda-authorises-first-covid-19-antibody-test 6. https://www.fda.gov/media/136625/download 7. https://www.linkedin.com/in/x-james-li-3a061416/
Organization:
X James Li (CEO) [7]
No. Tests Per Day:
serology strip >2000/ day
Time to Result:
15-20 minutes [3]
Test Sample Type:
whole blood, serum, plasma [3]
Technology Overview:
Lateral flow chromatographic immunoassay which can detect and differentiate IgM and IgG antibodies against the SARS-CoV-2 virus [3]
Testing Type:
qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 [3]
Test Category:
SEROLOGY
Test Name:
qSARS-CoV-2 IgG/IgM Rapid Test [3]
Clinical Application & Need:
“Aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests [6]”
Age of Company:
2002 [1,2]
Business Genre:
Business Description:

Chembio specializes in development, manufacture and commercialization of diagnostic solutions. Their focus is to develop products that provide ease of use, and rapid and accurate results at the point-of-care (POC) [2-3].

City:
Medford
State:
NY
Country:
USA
Data/Evidence of Effectiveness:
Extensive testing from populations in New York and East Asia were performmed. Positive Agreement, Negative agreement, corss reactivity, plasma vs. fingerstick data are all presented in company product insert available on request- file:///Users/shriya_s/Downloads/DPPCovid19TestPI-EUA.pdf
Complimentary Products Needed to Perform Test:
Must purchase DPP control IgM/ IgG pack and DPP Microreader with the test kit [1]
Setting of Care:
Point of care [1, 3]
Current Status / Clinical Development Stage / Expected Milestones:
FDA EUA authorized [4]. Company signed a multi-year, non‑exclusive agreement with Thermo Fisher Scientific’s healthcare channel, to distribute Chembio’s DPP COVID-19 System in the United States [2].
Funding & Ownership :
Private. Amount undisclosed [3].
Business Model:
Company strengths are product development, manufacturing and commercialization expertise. Chembio has products on the market in over 40 countries primarily for the rapid and early detection of HIV and syphilis. Chembio is involved in multiple collaborations to address several diseases [2]. They cater to the point of care market by developing quality rapid tests [3].
IP:
Yes- technology uses the company’s patented Dual Path Platform (DPP) [1-3].
History & Origins :
Company was founded in 1986 [3]. They develop, manufacture, licenses and markets proprietary rapid diagnostic tests in the point-of-care testing market. Chembio has developed a patented point-of-care test platform technology, the Dual Path Platform (DPP®) technology. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products based on DPP®. Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U. S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13.485 [2-3].
Date EUA Issued:
4/14/2020 [4]
Sources:
1. http://chembio.com/dpp-covid-19-igm-igg-system/ 2. http://chembio.com/about-us/ 3. https://www.crunchbase.com/organization/chembio-diagnostic-systems-inc#section-overview 4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Organization:
“Richard L. Eberly- President, Chief Executive Officer A. Goldman, CPA- Executive Vice President, Chief Financial Officer Javan Esfandiari- Executive Vice President, Chief Science and Technology Officer Robert Passas Ph.D.- Senior Vice President, Chief Commercial Officer Tom Ippolito- Vice President, Quality and Regulatory Affairs Paul Lambotte- Vice President, Research and Development Paul J. Angelico- Vice President, Global Operation”
No. Tests Per Day:
serology strip >2000/ day
Time to Result:
15 minutes [1]
Test Sample Type:
Fingerstick whole blood/ venous whole blood/ serum/ plasma [1]
Technology Overview:
“Rapid test for the detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in capillary “fingerstick” whole blood, venous whole blood, serum and plasma samples. Allows simultaneous and separate detection of IgM and IgG antibodies using their readers. Readers are simple to use, handheld, and portable. The test requires small sample size- 10 μL and results in 15 minutes. Can store at room temperature (2°C to 30°C; 36°F to 86°F) [1]. “
Testing Type:
Serology IgM/IgG Rapid Test for Fingerstick Blood [1]
Test Category:
SEROLOGY
Test Name:
DPP® COVID-19 IgM/IgG System [1]
Clinical Application & Need:
Detect and distinguish patients with IgM vs. IgG antibodies [1].
Age of Company:
1986 [3]