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

RT-PCR

Business Genre:
Business Description:

Aldatu is currently developing multiple PCR-based disease detection kits using their developed pan-degenerate amplification and adaptation (PANDAA) technology [9].

City:
Boston
State:
MA
Data/Evidence of Effectiveness:
Evaluations summary states 100.0% (95% CI: 95.5% – 100.0%) sensitivity and 98.0% (95% CI: 92.8% – 99.8%) specificity, with a limit of detection of 100 copies/mL [6, 7].
Complimentary Products Needed to Perform Test:
PCR equipment and associated sample prep tools [6].
Setting of Care:
If EUA is granted, assumed to be clinical research laboratories cerified to perform high complexity tests due to PCR equipment and process required [6, 7].
Current Status / Clinical Development Stage / Expected Milestones:
“Aldatu can provide templates, protocols, and reagents (e.g. in vitro transcribed SARS-CoV-2 RNA) for validation following FDA EUA guidance and dedicated Aldatu support (on-site, if needed) to facilitate the EUA validation process and test implementation. Inventory available immediately to enable on-site testing at additional laboratories.” [8]. For research use only as of 06/04/2020 [1, 6].
LOD:
100 copies/mL [7]
Funding & Ownership :
Private [5].Grant funding, raised $4.8M over five funding rounds [5]
Business Model:
Aldatu is currently developing PANDAA RT-PCR kits for research and clinical use for detection of several diseases, but none are currently available for clinical use [9].
IP:
None found
History & Origins :
Founded on January 7, 2014 [5]
Date EUA Issued:
No EUA issued [1]. For research use only [6].
Sources:
[1] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2]https://www.aldatubio.com/ [3] https://www.aldatubio.com/team/ [4] https://www.aldatubio.com/solution/ [5] https://www.crunchbase.com/organization/aldatu-biosciences [6] http://www.aldatubio.com/wp-content/uploads/2020/04/PANDAA-qDx-SARS-CoV-2-Product-Sheet-2020-04-16-v2.0.pdf [7] http://www.aldatubio.com/wp-content/uploads/2020/05/PANDAA-qDx-SARS-CoV-2-Validation-Data-External-Summary-v2.2.pdf [8] https://www.aldatubio.com/news/aldatu-enables-on-site-covid-19-testing-at-major-boston-hospital/ [9] https://www.aldatubio.com/pipeline/
Organization:
David Raiser (Co-Founder, CEO); Iain MacLeod (Co-Founder, CSO); Betsy Wonderly Trainor (VP Development) [3]
No. Tests Per Day:
94 tests/run x 1 run/1hour x 24 hours/day=2256 tests/day
Time to Result:
Results in 1-2 hours [4], results from RNA in 1 hour [6], with 94 samples/run [7].
Test Sample Type:
Assumed to be upper respiratory samples based on evaluation summary [7].
Technology Overview:
Uses a specialized form of RT-PCR developed by Aldatu known as Pan-Degenerate Amplification and Adaptation (PANDAA), which reduces errors and ensures high sensitivity and specificity [7].
Testing Type:
Specialized form of RT-PCR
Test Category:
RT-PCR
Test Name:
PANDAA qDx SARS-CoV-2 [2]
Clinical Application & Need:
Qualtitative nucleic acid test [6], assumed to be applicable for detection of active infection based on RNA validation studies [7].
Age of Company:
6 years old, founded in 2014 [5]
Business Genre:
Business Description:

3D Medicines is a precision medicine company that helps patients with early and personalized diagnosis [2]. Based in China, this company uses “automated molecular diagnostics” and AI to help physician make tailored patient decisons and treatments [2].

City:
Minghang
State:
Shanghai
Country:
China
Data/Evidence of Effectiveness:
100 out 111 clinical specimens tested using this kit met the requirement of qualilty control when evaulated against next generation sequencing [6]. The kit had 100% agreement when testing in parallel with the US CDC 2019-nCoV assay [6].
Complimentary Products Needed to Perform Test:
ANDis 350 Automated Nucleic Acid Extraction System and ABI 7500 Real-Time PCR System [3]
Setting of Care:
Presumably clinical settings
Current Status / Clinical Development Stage / Expected Milestones:
Commercially available through Todos Medical in the New York Area and Israel [5].
LOD:
200 [9]
Funding & Ownership :
Private; 950 Million Chinese Yuan or US$133.23 Million from venture funding [1].
Business Model:
They provide next generation sequencing for oncology testing and diagnoses in China [7]. Also make hardware and software for nucleic acid extraction, detection and analysis [8].
IP:
The kit doesn’t seem protected but the extraction machine is proprietary [5].
History & Origins :
This company was the first to launch a fully enclosed automated NGS library prep system and had previous experience in clinical lab testing [2]. They leveraged those expertise to make SARS-CoV-2 detection kits in response to the outbreak [2].
Date EUA Issued:
CE Certification on 3/17/2020 [4]. Entered review and approval phase for US FDA on 3/18/2020 but isn’t on the EUA website [5].
Sources:
[1] https://www.crunchbase.com/organization/3d-medicines. [2] http://www.3dmedcare.com/company/about.htm [3]http://www.3dmedcare.com/covid/ [4] http://www.3dmedcare.com/infocenter/news/307.htm [5] http://www.3dmedcare.com/infocenter/news/308.htm [6] http://www.3dmedcare.com/covid/ [7] http://www.3dmedcare.com/product/LDT.htm [8] http://www.3dmedcare.com/product/IVD.htm [9] http://www.3dmedcare.com/UploadImage/covid/02PerformanceEvaluationof3DMed2019-nCoVRT-qPCRDetectionKit.pdf
Organization:
Founded by John Gong and Simon Shung [1].
No. Tests Per Day:
N/A
Time to Result:
Not found, but should be similar to other qPCR test.
Test Sample Type:
Upper and lower respiratory specimens [3]
Technology Overview:
Uses RT-qPCR to target sequences specific to SARS-CoV-2 with no cross reactivity SARS-CoV or MERS-CoV [3].
Testing Type:
Qualitative RT-qPCR test for nucleic acids [3]
Test Category:
RT-PCR
Test Name:
ANDiS SARS-CoV-2 RT-qPCR Detection Kit [3]
Clinical Application & Need:
Qualitative detection of SARS-Cov-2 RNA in specimens [3]
Age of Company:
Founded in 2010 [1]
Business Genre:
Business Description:

Abbott is a leader in molecular diagnostics with over 1000 employeess focused on exploring areas including infectious disease, oncology and instrumentation [1].

City:
Abbott Park
State:
IL
Country:
USA
Data/Evidence of Effectiveness:
Inclusivity was established by comparing the primers used in this kit to SARS-CoV-2 sequences available in Genbank as of March 5 2020 [4].
Complimentary Products Needed to Perform Test:
Abbott RealTime m2000 system [2]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [2].
Current Status / Clinical Development Stage / Expected Milestones:
EUA authorized. Waived current good manufacturing practice requirements [5]. Designed for only in vitro diagnostic use [2].
LOD:
100 [10]
Funding & Ownership :
Public, Market Cap – $161.797B [7].
Business Model:
Abbott offers solutions across various facets of the life sciences including instrumentation, infectious diseases, informatics, oncology, and genomics [6]
IP:
N/A for the kit but presumably the m2000 has some proprietary protection.
History & Origins :
Previous experience in genomics, infectious diseases and oncology allowing for an easy pivot into SARS-CoV-2 diagnostics [8].
Date EUA Issued:
03/18/2020 [3]
Sources:
[1] https://www.molecular.abbott/us/en/home [2] https://www.molecular.abbott/us/en/products/infectious-disease/RealTime-SARS-CoV-2-Assay [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [4] https://www.molecular.abbott/sal/9N77-095_SARS-CoV-2_US_EUA_Amp_PI.pdf [5] https://www.fda.gov/media/136255/download [6] https://www.molecular.abbott/us/en/offerings/products [7] https://finance.yahoo.com/quote/ABT/ [8] https://www.molecular.abbott/us/en/offerings/products/featured [9] https://finance.yahoo.com/quote/ABT/profile?p=ABT [9] https://en.wikipedia.org/wiki/Abbott_Laboratories [10] https://www.fda.gov/media/136258/download
Organization:
Robert B. Ford (CEO, Pres, COO & Director), Robert E. Funck Jr (Executive VP of Finance and CFO), Lisa D. Earnhardt (Executive VP of Medical Devices), Miles D. White (Executive Chairman), Scott Michael Leinenweber (VP of Investor Relations) [9]
No. Tests Per Day:
470 [2]
Time to Result:
Up to 470 pateint samples tested in 24 hours [2].
Test Sample Type:
Self-collected nasal swabs, nasopharyngeal and oropharyngeal swabs collected by a healthcare worker [2].
Technology Overview:
A fully automated solution, which uses RT-qPCR to detect RdRP and N-genes from nasal samples [2]
Testing Type:
Qualitative RT-qPCR test for nucleic acids [2]
Test Category:
RT-PCR
Test Name:
Abbott RealTime SARS-CoV-2 assay
Clinical Application & Need:
Qualitative detection of nucleic acids from SARS-CoV-2 [2].
Age of Company:
1888 [9]
Business Genre:
Business Description:

With a background in infectious diseases and molecular technoIogies, this company focuses on RT-PCR and other technologies for in vitro diagnostic purposes [2].

State:
Hamburg
Country:
Germany
Data/Evidence of Effectiveness:
N/A
Complimentary Products Needed to Perform Test:
Any of the following instruments: Mx3005P QPCR System, VERSANT kPCR Molecular System AD, ABI Prism 7500 SDS, LightCycler 480 Instrument II, Rotor-Gene 6000, Rotor-Gene Q 5/6 plex Platform, CFX96 Deep Well Real-Time PCR Detection System, CFX96 Deep Well Dx System, CFX96 Real-Time Detection System, CFX96 DX System [5].
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [3].
Current Status / Clinical Development Stage / Expected Milestones:
EUA authorized. Waived current good manufacturing practice requirements [5]. Designed for only in vitro diagnostic use [3].
LOD:
127 [10]
Funding & Ownership :
Private, Estimated annual revenue – $5M [8].
Business Model:
Offer a range of PCR based technologies with their main product families being the AltoStar (for automated pipetting, and PCR setup/reagents) [6] and RealStar [7].
IP:
N/A
History & Origins :
Previous experience in molecular diagnostics, particularly in infectious disease [9].
Date EUA Issued:
04/22/2020 [4]
Sources:
[1] https://www.altona-diagnostics.com/en/ [2] https://www.altona-diagnostics.com/en/about-us/portrait.html [3] https://www.fda.gov/media/137257/download [4] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [5] https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit-ruo.html [6] https://www.altona-diagnostics.com/en/products/instrumentation/altostar-am16.html [7] https://www.altona-diagnostics.com/en/products/reagents.html [8] https://www.owler.com/company/altona-diagnostics [9] https://www.altona-diagnostics.com/en/about-us/history.html [10] https://www.fda.gov/media/137252/download
Organization:
Ulrich Spengler (Managing Director), Markus Hess (Partner), Thomas Laue (Partner) [9].
No. Tests Per Day:
96* 18 = 1728
Time to Result:
Approximately 79 mins based on time instructions for use [10]
Test Sample Type:
Nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes and nasal aspirates [3]
Technology Overview:
A reagent based system that is dependent on RT PCR and differentiates itself by the extra confirmation of B-betacoronavirus RNA [5].
Testing Type:
Qualitative RT-qPCR test for nucleic acids specific to B-betacoronavirus and SARS-CoV-2 [5].
Test Category:
RT-PCR
Test Name:
RealStar SARS-CoV-2 RT-PCR Kit U.S.
Clinical Application & Need:
Qualitative detection of nucleic acids in specimens obtained from patients suspected of having SARS-CoV-2 [3].
Age of Company:
2007 [8]
Business Genre:
Business Description:

Diagnostics company focused on “developing novel chemistry for nucleic acid amplification and detection of clinical diagnostic applications.” [7].

City:
Mountainview
State:
CA
Data/Evidence of Effectiveness:
Health provider fact sheet states that while the test has been designed to reduce likelihood of false positive results, both false positive and false negative results are possible. Consideration of COVID-19 exposure and associated symptoms are recommended as secondary considerations to the test result [3]. Includes internal, positive, and negative controls which must produce the expected result for a sample test to be considered valid [2]. Reported 100% positive and negative detection rates, though confidence intervals are not given [4].
Complimentary Products Needed to Perform Test:
Internal Control (human Gapdh gene in clinical sample), Positive Template Control, Negative Template Control, other materail required but not included in kit outlined in Instruction For Use [2].
Setting of Care:
“””Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.”” [2].”
Current Status / Clinical Development Stage / Expected Milestones:
Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2].
LOD:
4 copies/uL x 1000uL/mL= 4,000 copies/mL [4]
Funding & Ownership :
Information not available
Business Model:
Atila Biosystems develops and directly sells diagnostic kits for infectious diseases, cancer, and prenatal applications [6].
IP:
AU2018313286A1(published 03-12-2020, status pending), Australian patent for “digital amplification with primers of limited nucelotide compostition.” [9].
History & Origins :
Started in 2009, primarily develops diagnostics for infectious diseases, cancer, and prenatal applications [6, 7].
Date EUA Issued:
04/10/2020 [1]
Sources:
[1]https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2] https://www.fda.gov/media/136872/download [3] https://www.fda.gov/media/136869/download [4]https://www.fda.gov/media/136870/download [5] https://atilabiosystems.com/our-products/covid-19/ [6] https://atilabiosystems.com/our-products/ [7]https://atilabiosystems.com/about-us/ [8] https://atilabiosystems.com/contact-us/ [9] https://patents.google.com/patent/AU2018313286A1/en?assignee=Atila+Biosystems+Incorporated
Organization:
Information not avaliable
No. Tests Per Day:
94 tests/run x 1 run/1 hour x 24 hours/day=2256 tests/day
Time to Result:
Sample-to-result in about 1 hour, up to 94 samples per run [5].
Test Sample Type:
nasal, nasopharyngeal, and oropharyngeal swabs [2].
Technology Overview:
detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [2]
Testing Type:
qualitative viral RNA test, RT-PCR based with isothermal amplification [2]
Test Category:
RT-PCR
Test Name:
iAMP COVID-19 Detection Kit [1]
Clinical Application & Need:
A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [3]
Age of Company:
11 years old, founded in 2009 [7]
Business Genre:
Business Description:

The company is focused on precision medicine, and creating oppurtunities for earlier disease protection, staring with opthalmology [1]

City:
Menlo Park
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
100 % positive and negative agreement on the patient samples [3]
Complimentary Products Needed to Perform Test:
QIAamp DSP Viral RNA Mini Kit, RT-qPCR Master Mix, and Applied Biosystems 7500 Fast Real-Time PCR System [3]
Setting of Care:
“Testing is limited to Avellino Lab USA, Inc., that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests. [2]”
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
55000 [3]
Funding & Ownership :
Private (Accelerator/Incubator Backed) [5]
Business Model:
Company sells proudcts related to genetic tests for diagnostic [4]
IP:
N/A
History & Origins :
Found in 2008 to provide provide genetic testing and diagnostic services [1]
Date EUA Issued:
March 25, 2020 [2]
Sources:
“[1] https://www.avellino.com/en/about/ [2] https://www.fda.gov/media/136450/download [3] https://www.fda.gov/media/136453/download (EUA summary) [4] https://www.avellino.com/en/products/diagnostics/ [5] https://pitchbook.com/profiles/company/170839-00#funding [6] https://www.avellino.com/en/about/leadership/ [7] https://www.avellino.com/en/contact/”
Organization:
Gene Lee (Founder), Tara Moore (Director of R&D), Thomas Kim (CSO), Scott Korney (COO) [6]
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
Not stated, but should be similar to other RT-PCR based method
Test Sample Type:
nasopharyngeal and oropharyngeal swab [2]
Technology Overview:
“A real-time reverse transcription polymerase chain reaction(rRT -PCR) test. Use two sets of primers to detect two regions in SARS-CoV-2 nucleocapsid (N) gene and one set of primer to detect human RNase P (RP). [3]”
Testing Type:
Viral rRT-PCR test [2]
Test Category:
RT-PCR
Test Name:
AvellinoCoV2 test
Clinical Application & Need:
Qualitative detection of nucleic acid from SARS-CoV-2 [2]
Age of Company:
2008
Business Genre:
Business Description:

A global medical technology company that is focusing on advancing medical discovery, diagnostics, and delivery of care. [1]

City:
Franklin Lakes
State:
NJ
Country:
USA
Data/Evidence of Effectiveness:
Low positive sample showed 95% positive agreement, while moderate positive sample showed 100% positive agreement. Negative samples showed 100% negative agreement. [4]
Complimentary Products Needed to Perform Test:
BD MAX System and BD UVT Collection Kit [4]
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 tests. [2]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
40 [4]
Funding & Ownership :
Delisted [5], Cap: 72.814 B [6]
Business Model:
The company provides various products in medical research, diagnosis of infectious disease and cancer, equip surgical and interventional procedures and support the management of diabetes. [1]
IP:
BD Max system is registered as a trademark [7]
History & Origins :
BD is a global company that focuing on medical innovation and clinical excellence. They provided products in numerous area of diagnosis of infectious diseases and cancer. [1]
Date EUA Issued:
04/08/2020 [2]
Sources:
“[1] https://www.bd.com/en-us/company [2] https://www.fda.gov/media/136813/download [3] https://www.bd.com/en-us/offerings/capabilities/molecular-diagnostics/molecular-tests/biogx-sars-cov-2-reagents [4] https://www.fda.gov/media/136816/download [5] https://www.crunchbase.com/organization/becton-dickinson#section-overview [6] https://finance.yahoo.com/quote/BDX?p=BDX&.tsrc=fin-srch [7] https://www.bd.com/en-us/offerings/capabilities/molecular-diagnostics/molecular-systems/bd-max-system [8] https://www.bd.com/en-us/company/executive-leadership”
Organization:
Simon Campion, Gary Cohen, Alexandre Conroy, John Deford, Tony Ezell, Jerry Flasz (Executive Vice President) [8]
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
No information
Test Sample Type:
Nasal, nasopharyngeal and oropharyngeal swab [2]
Technology Overview:
Paired with the BD MAX system, after loading the samples to the buffer tube, all the following steps of nucleuic acid extraction and PCR are done automatically. Detect 2 region of the N genes. Human RNase P gene amplifcation serve as internal control. [4]
Testing Type:
Real-time RT-PCR test using the BD MAX System [3][4]
Test Category:
RT-PCR
Test Name:
BioGX SARS-CoV-2 Reagents for BD MAX™ System [3]
Clinical Application & Need:
Qualitative test for the detection of nucleic acid from SARS-CoV-2 [2]
Age of Company:
1897
Business Genre:
Business Description:

One of the world’s largest genomics companies – with a primary forcus in providing high quality sequencing services [1]

City:
Cambridge
State:
MA
Country:
USA
Additional Addresses:
Hong Kong, China
Data/Evidence of Effectiveness:
Limit of detection is 100 copies/mL (BALF); 150 copies/mL (Throat swabs) [3]. Reactivity/Inclusivity was done by mapping assay to 284 complete SARS-CoV-2 genomes of human host in GenBank and GISAID databases as of March 10th 2020 [3]. No cross reactivity with 54 humar respiratory pathogens [3].
Complimentary Products Needed to Perform Test:
Qiagen RNA extraction kits, Roche LightCycler 480, Applied Biosystems 7500 Fast, QuantStudio 5 RealTime PCR Systems [3]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [2].
Current Status / Clinical Development Stage / Expected Milestones:
EUA authorized. Waived current good manufacturing practice requirements [2]. Designed for only in vitro diagnostic use [2].
LOD:
150 [8]
Funding & Ownership :
Public, Market Cap – 39.53 Billion Chinese Yuan/US$5.54 Billion [4]
Business Model:
Offer primarily services for pharmaceutical drug development – including genomic sequencing and mass spectrometry [1].
IP:
N/A
History & Origins :
Previous experience in genomic and proteomic technologies with customers from all over the world [5].
Date EUA Issued:
03/26/2020 [2] Ammended 04/24/2020 [3]
Sources:
[1] https://www.bgi.com/us/ [2] https://www.fda.gov/media/136473/download [3] https://www.bgi.com/us/sars-cov-2-real-time-fluorescent-rt-pcr-kit-ivd/ [4] https://finance.yahoo.com/quote/300676.SZ?p=300676.SZ&.tsrc=fin-srch [5] https://www.bgi.com/us/company/about-bgi/ [6] https://finance.yahoo.com/quote/300676.SZ/profile?p=300676.SZ [7] https://en.wikipedia.org/wiki/BGI_Group [8] https://www.fda.gov/media/136472/download
Organization:
Ye Yin (CEO, GM & Director), Yiqing Chen (CFO), Qian Xu (Director of Legal Affairs, General Counsel and Secretary), Zhiping Li (Chief Human Resource Officer), Wei Wang (Chief Medical Officer) [6]
No. Tests Per Day:
192*6 = 1152
Time to Result:
Test results within 4 hours for 192 samples [3].
Test Sample Type:
Oropharyngeal swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) [3].
Technology Overview:
Pre-mixed reaction reagents coupled with automated sample preparation and ORF1ab targeting allow for quick output of results from this technology [3].
Testing Type:
Automated sample preparation system and RT-qPCR detection of ORF1ab gene from SARS-CoV-2 [3].
Test Category:
RT-PCR
Test Name:
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
Clinical Application & Need:
Qualitative test for the detection of SARS-CoV-2 nucleic acids [2].
Age of Company:
1999 [7]
Business Genre:
Business Description:

CLIA-certified and CAP-accredited laboratory dedicated to delivering clinical diagnostics tests to improve patients’ safety and quality of care [2]

City:
Fulton
State:
MD
Country:
USA
Data/Evidence of Effectiveness:
Positive Percent Agreement (PPA): 30/30 = 100%, Negative Percent Agreement (NPA): 30/30 = 100% [4]
Complimentary Products Needed to Perform Test:
MagMAX Viral/Pathogen Nucleic acid isolation kit and QuantStudio 5 real-time PCR system [4]
Setting of Care:
Biocerna, certified under the Clinical Laboratory Improvement Amendments of 1988(CLIA), 42 U.S.C. §263a [4]
Current Status / Clinical Development Stage / Expected Milestones:
The procedure received the EUA and ready to perform [3]
LOD:
250-375 [4]
Funding & Ownership :
Revenue: 5 million [5]
Business Model:
They are clinical lab that help performing the diagnostic tests [2]
IP:
N/A
History & Origins :
N/A
Date EUA Issued:
04/28/2020 [3]
Sources:
“[1] http://www.biocerna.com/ [2] https://www.linkedin.com/company/biocerna/about/ [3] https://www.fda.gov/media/137451/download [4] https://www.fda.gov/media/137450/download [5] https://www.zoominfo.com/c/biocerna-llc/374918733”
Organization:
Christopher Sanders (CEO)
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
N/A
Test Sample Type:
nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab and bronchoalveolar lavage (BAL) specimens [4]
Technology Overview:
The test is not a new kit, it uses the ThermoFisher Scientific TaqPath COVID-19 Combo Kit that was FDA authorized for emergency use (EUA) on March 13, 2020. 3 regions from SARR-CoV2 are used: the Orf1ab, N gene and S gene. [4]
Testing Type:
real-time reverse PCR for qualitative detection of nucleic acid from SARS-CoV-2 [4]
Test Category:
RT-PCR
Test Name:
SARS-CoV2-Test
Clinical Application & Need:
acute infection [3]
Age of Company:
2012
Business Genre:
Business Description:

A company focused on in vitro diagnostics for more than 55 years. Present in 44 countries and serves more than 160 countries. [2]

Country:
France
Data/Evidence of Effectiveness:
For target genesN & RdRp gene), there was 100% positive agreement and 100% negative agreement [4]
Complimentary Products Needed to Perform Test:
Depends on the instrument of choice. Extraction systems validated with the kit, and Amplification platforms validated with the kit. [4]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. [3]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approval and available for sale [2]
LOD:
380 [4]
Funding & Ownership :
Public [6], Cap: 15.201 B [7]
Business Model:
Sell proudcts that is related to clinical diagnostics. Provide several management to infectious dieseases as well as selling the kit for diagnostics. [5]
IP:
“Some of the reagents in the kits is the subject of one or more issued US patents. [4]”
History & Origins :
The company has an entrepreneurial spirit and many products, services and solutions for in vitro diagnostics are developed in-house. Recently merge with several different companies. [8]
Date EUA Issued:
05/06/2020 [2]
Sources:
“[1] https://www.biomerieux.com/en [2] https://www.biomerieux.com/en/our-company [3] https://www.fda.gov/media/137743/download [4] fda.gov/media/137742/download [5] https://www.biomerieux-diagnostics.com/ [6] https://www.crunchbase.com/organization/biomerieux [7] https://finance.yahoo.com/quote/BIM.PA?p=BIM.PA [8] https://www.biomerieux-diagnostics.com/our-clinical-history”
Organization:
“Stephane Bancel (CEO), Carine Malcus-Vocanson (Director of clinial affairs) [6]”
No. Tests Per Day:
assume prep time + run time 3 hrs for every 96 samples, ~800 / day
Time to Result:
Depends on the instrument of use. Similar to tradition RT-PCR methods [4]
Test Sample Type:
Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes and bronchoalveolar lavage (BAL) fluid [3]
Technology Overview:
Can be paired with several extraction and amplification instruments. Target the N gene and RdRp gene of the SARS-CoV-2. [4]
Testing Type:
Real-time reverse transcriptase (RT)-PCR test [4]
Test Category:
RT-PCR
Test Name:
SARS-COV-2 R-GENE
Clinical Application & Need:
Qualitative detection of nucleic acid from SARS-CoV-2 [3]
Age of Company:
1963