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

DiaCarta, Inc.

Business Name:
DiaCarta, Inc.
Business Genre:
Business Description:

A translational genomics and personalized diagnostics company [5], specializing in precision molecular diagnostics [4].

City:
Hayward
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 Control, Positive Controls, Extraction Control, and No Template Control [2]. Reported 100% (72.3-100%) sensitivity and 100% (90.6-100%) specificity [7]. Product webpage lists 96.7% (95% CI, 81.4%-99.8%) clinical sensitivity and 100% (95% CI, 85.4%-100%) specificity [9].
Complimentary Products Needed to Perform Test:
5x Primer/probe mix, One step qRT-PCR master mix, Internal Control (RNase P control in a clinical sample), Positive Controls (synthetic DNA templates for N, Orflab, and E genes), Extraction Control (ribosomal protein gene in vitro transcribed RNA), and No Template Control (nuclease-free, molecular grade water) [2]. Required use of other authorized materials and reagents described in IFU, including an authorized RT-PCR instrument [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:
200 copies/mL on ABI QuantStudio 5, 100 copies/mL on ABI 7500 Fast Dx [4]
Funding & Ownership :
Private: Early Stage Venture. Cumulative $53M in funding over two rounds, most recent being a Series B which gathered $45M [4].
Business Model:
Diacarta directly sells molecular diagnostic kits, primarily focused on cancer diagnoses [5, 8].
IP:
CA2803753C (03-10-2020), Canadian patent for kits/methods for determining presence of an infectious agent in a sample [10].
History & Origins :
Early stage venutre started in 2011, main focus on precision molecular diagnostics for cancer treatments [4].
Date EUA Issued:
04/08/2020 [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/136806/download [3] https://www.fda.gov/media/136807/download [4] https://www.crunchbase.com/organization/diacarta#section-overview [5]https://diacarta.com/ [6] https://diacarta.com/about#leadership [7] https://www.fda.gov/media/136809/download [8]https://diacarta.com/about [9] https://diacarta.com/products/coronavirus-test [10] https://patents.google.com/patent/CA2803753C/en?assignee=Diacarta+Inc&language=ENGLISH&type=PATENT
Organization:
Aiguo Zhang, Ph.D. (President, CEO, Founder); Michael J. Powell, Ph.D. (Chief Scientific Officer); Paul Okunieff, M.D. (Chief Medical Officer); Laird Q. Cagan (Chief Finiancial Officer) [6]
No. Tests Per Day:
92 tests/run x 1 run/2 hours x 24 hours/day=1104 tests/day
Time to Result:
“Less than 2 hours from RNA to results on most qPCR machines.” [9].
Test Sample Type:
nasal swabs, nasopharyngeal swabs, oropharyngeal swabs and sputum [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 [2]
Test Category:
RT-PCR
Test Name:
QuantiVirus SARS-CoV-2 Test 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:
9 years old, founded in 2011 [4]

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