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

Mesa Biotech Inc.

Business Name:
Mesa Biotech Inc.
Business Genre:
Business Description:

San Diego-based next-gen molecular diagnostics company, focused on nucleic acid PCR amplification and making diagnostics more accessible. Has proprietary OSCAR technology that is basis to all of their diagnostics. [2]

City:
San Diego
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
LOD of 100 genomic copies/reaction, tested in throat swab human clinical matrix. No cross-reactivity with 32 potential organisms, also no interference from a series of human specimens or cold and flu medications. Functioned as expected with contrived samples from healthy volunteers [3]
Complimentary Products Needed to Perform Test:
Kit provides: collection swabs (25), buffer (25), transfer pipette (25), test cassette (25), high positive control swab (1), low positive control swab (1), negative control swab (1), instructions, and quick reference guide. Still required: Accula dock or Silaris dock, Accula SARS-CoV-2 Control Kit (Silaris dock available for $180) [3][5]
Setting of Care:
H, M, and W [1]
Current Status / Clinical Development Stage / Expected Milestones:
EUA approved 3/23/2020, kits available for sale and was able to ship 10,000 kits in early April [1] [4]
Funding & Ownership :
“Worked with Los Alamos National Lab supported by NIH and National Institute of Allergy and Infectious Diseases (NIAID) and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program, also funded by U.S. Health and Human Services. [4]”
Business Model:
Develops and sells more accessible nucleic amplification diagnostic kits, similar to how this kit uses a small docking system rather than a thermocycler [2]
IP:
patented and proprietary tech [2]
History & Origins :
Company produces PCR amplifcation diagnostic tests alrready [2]
Date EUA Issued:
3/23/2020 [1]
Sources:
[1] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [2] https://www.mesabiotech.com/company-leadership [3] https://static1.squarespace.com/static/5ca44a0a7eb88c46af449a53/t/5ec4223ec578f6019605b2d0/1589912128672/60061+Rev+3+Accula+SARS-CoV-2+IFU.pdf [4] https://www.mesabiotech.com/news/euacoronavirusupdate [5] https://www.fishersci.com/shop/products/silaris-dock-use-silaris-in-vitro-diagnostic-assays/22321115
Organization:
President and CEO: Ingo Chakravarty. CTO: Hong Cai. CSO: R. Bruce Cary. VP of Global Business Development & Channel Management: Steven Sepulveda. VP of Quality Assurance: Julie Richardson. VP of Engineering and Product Development: Don Thomas. Senior Director of HR: Pam Fettu [2]
Time to Result:
30 minutes [3]
Test Sample Type:
nasal swab [ specimens (~1 inch up nose) [3]
Technology Overview:
PCR and lateral flow cassette allows for nasal swab to be put into small (hand-sized) dock and get results of COVID-19 infection within 30 minutes. Targets N gene [3]
Testing Type:
PCR and lateral flow [3]
Test Category:
RT-PCR
Test Name:
Accula SARS-Cov-2 Test [1]
Clinical Application & Need:
detect current infection from nasal swab [3]

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