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

CRISPR

Business Genre:
Business Description:

College of American Pharmacists (CAP)-accredited national reference laboratory, including anatomical and molecular diagnostics divisions [5].

City:
Atlanta
State:
GA
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 [2]. Kit contains internal control, positive extraction control, negative extraction control, and no template (negative) control, which must all generate epected results for test to be considered valid [3]. Reported 100% (95% CI: 90.4% – 100%) sensitivity and 100% (95% CI: 88.7% – 100%) specificity [6].
Complimentary Products Needed to Perform Test:
RNase P (RP) control in clinical samples (internal control), positive extraction control (contains DNA sequence of nCoV nucleoplasmid gene), negative extraction control (previously captured negative patient sample), no template (negative) control (nuclease-free, molecular grade water) [3]. According to EUA summary, “The COV-19 IDx assay is to be used with the KingFisher Flex nucleic acid extraction systems using the Omega Bio-Tek Mag-Bind Viral DNA/RNA 96 Kit and QS12 instrument with software version 1.2.2.,” and thus requires specific RT-PCR equipment (the QS12 instrument) [6].
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 diagnosis of SARS-CoV-2 infection [3]. Currently available for purchase[4].
LOD:
8.5 copies/uL x 1000uL/mL=8,500 copies/mL [6]
Funding & Ownership :
Information not available
Business Model:
Reference lab which conducts specialized diagnostic patient services for profit [5].
IP:
N/A
History & Origins :
Reference laboratory specializing in performance of molecular/RT-PCR diagnoses [5, 7].
Date EUA Issued:
04/01/2020 [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/136619/download [3] https://www.fda.gov/media/136618/download [4]https://ipsumdiagnostics.com/ [5]https://ipsumdiagnostics.com/about/ [6]https://www.fda.gov/media/136621/download [7]https://www.zoominfo.com/c/ipsum-diagnostics-llc/402435074
Organization:
Colin Rogers (CEO, Co-founder); Lauren Bricks (COO, Co-Founder); Elizabeth Brunelli (Quality Director); Henry Skelton, MD, FCAP (Laboratory Medical Director); Steven I. Marlowe, MD, FACP, FIDSA (Medical Director, Molecular Diagnostics); [5]
No. Tests Per Day:
1,000-4,000 tests/day [4]
Time to Result:
FDA approved Ipsum Diagnostics to perform 1,000-4,000 tests/day, allowing for results within 24 hours [4].
Test Sample Type:
nasopharyngeal or oropharyngeal swabs [3]
Technology Overview:
detects presence of RNA originating from SARS-CoV-2 in samples taken from upper respiratory system [3]
Testing Type:
qualitative viral RNA test, RT-PCR based [3]
Test Category:
RT-PCR
Test Name:
COV-19 IDx assay[1]
Clinical Application & Need:
A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [2]
Age of Company:
information not available
Business Genre:
Business Description:

Caspr Biotech is a new company developing disposable CRISPR-based diagnostic devices [2].

City:
San Francisco
State:
CA
Data/Evidence of Effectiveness:
None available
Complimentary Products Needed to Perform Test:
None other than the disposable test strip/device itself [4].
Setting of Care:
Point-of-care, home, laboratory [2, 4]
Current Status / Clinical Development Stage / Expected Milestones:
Assumed to be in very early development based on lack of information available
LOD:
Information not available
Funding & Ownership :
Private, seed funding status [3]. Gathered $450,000 in 3 funding rounds [3].
Business Model:
Caspr Biotech is developing CRISPR-based disposable tests for disease detection (still early in development) [2]
IP:
None found
History & Origins :
Founded in 2018, focused on developing disposable CRISPR-based diagnostic devices [2, 3]
Date EUA Issued:
No EUA issued
Sources:
[1] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2]https://caspr.bio/ [3] https://www.crunchbase.com/organization/caspr [4]https://caspr.bio/technology.html [5]https://kaloramainformation.com/point-of-care-testing-for-covid-19/
Organization:
Franco Goytia (Founder) [3]
No. Tests Per Day:
Disposable single use test, if considered comparable to a serology strip then >2000/day
Time to Result:
Results in less than 30 minutes [4].
Test Sample Type:
Assumed to be blood sample based on Caspr Biotech technology webpage [4].
Technology Overview:
Point-of-care disposable test which utilizes CRIPSR to detect disease nucleic acid sequences [4]
Testing Type:
CRIPSR-based nucleic acid detection, disposable point-of-care test [2, 4]
Test Category:
CRISPR
Test Name:
Phantom 1.0 Dx [5]
Clinical Application & Need:
Nucleic acid test [4], assumed to be qualitiative.
Age of Company:
2 years old, founded in 2018 [3]
Business Genre:
Business Description:

San Francisco-based company that uses CRISPR-Cas9 tech to “address challenges across healthcare, agriculture, environmental monitoring, biodefense, and more”. Team includes Jennifer Doudna, co-inventor of CRISPR-Cas genome editing [4]

City:
San Francisco
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
95% positive predictive agreement and 100% negative predictive agreement. LOD is 10 copies/uL. Does not cross react with other respiratory viruses. [3]
Complimentary Products Needed to Perform Test:
Kit not commercialized yet. [3]
Setting of Care:
Not authorized, but likely authorized setting H [3]
Current Status / Clinical Development Stage / Expected Milestones:
Awaiting EUA approval [2]
Funding & Ownership :
privately owned by investors, mix of companies and individuals listed on website [4]
Business Model:
don’t seem to produce or sell any physical materials, possibly sell IP [4]
IP:
paper is copyrighted to publisher, DETECTR system is proprietary [3] [2]
History & Origins :
Company focuses on development of CRISPR-cas tech for diagnostics, genome editing, and protein discovery, DETECTR platform can detect other infectious diseases [4] [5]
Date EUA Issued:
Currently under review [1] [2]
Sources:
[1] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd [2] https://www.webwire.com/ViewPressRel.asp?aId=259386 [3] https://www.nature.com/articles/s41587-020-0513-4 [4] https://mammoth.bio/about/ [5] https://mammoth.bio/diagnostics/
Organization:
CEO: Trevor Martin. CTO: Janice Chen. CSO: Lucas Harrington. Chair of Scientific Advisory Board: Jennifer Doudna. Chief Busines Officer: Peter Nell. Legal Counsel: William Smith. Chief Operations Officer: Ted Tisch [4]
Time to Result:
40 minute runtime after RNA extraction and prep [3]
Test Sample Type:
nasopharyngeal swab, oropharyngeal swab [3]
Technology Overview:
CRISPR-cas12 holds piece of target DNA and finds match in solution, and cuts DNA at site. Then cutting is ‘active’ and continues to cut fluorescent probes away from quenchers that are also in solution. Targets the E and N genes. [3]
Testing Type:
CRISPER-cas12 lateral flow with RT-LAMP [3]
Test Category:
CRISPR
Test Name:
DETECTR [2] [3]
Clinical Application & Need:
detect current infection from respiratory swab RNA extracts [3]