Co-Diagnostics, Inc.

Business Name: Co-Diagnostics, Inc.
Business Genre:
Business Description:

A molecular technologies company, focused on providing low-cost molceular diagnostics for infectious dieases and cancer applications, as well as agricultural appications [5].

City: Salt Lake City
State: UT
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 positive control, internal positive control, and negative control, which must produce expected results for the test to be considered valid [2]. Reported 100% (95% CI: 86.7-100%) sensitivity [4]. Product webpage states 99.52% sensitivity and 100.00% specificity [10].
Complimentary Products Needed to Perform Test: Internal Positive Control (RNase P in clinical samples), Logix Smart COVID-19 Postive Control (blend of synthetic SARS-CoV-2 templates), No Template/Negative Control (Nuclease-free, molecular grade water) [2]. Othe required materials not included in the kit are outlined in instructions for use (IFU) [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.” [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: 4,290 copies/mL [4]
Funding & Ownership : Public (Market Cap $496.013M) [8, 9]
Business Model: Co-Diagnostics directly sells their diagnostic products, as well as customized design of their “CoPrimer” technology for specific applications as a service [7].
IP: US8673569B2 (03-18-2014, exp. 02-15-2032), U.S. patent for “primers for nucleic acid extension or amplification reactions.” [11]. US8815514B2 (08-26-2014, exp. 12-13-2030), U.S. patent for “detection primers for nucleic acid extension or amplification reactions.” [12]. US9410189B2 (08-09-2016, exp. 10-29-2032), U.S. patent for “methods of preventing non-specific reactions of nucelotide sequences.” [13].
History & Origins : Founded in 2013 [8], develops molecular diagnostics for cancer and infectious diseases (including Mycobacteria Tuberculosis, Zika Virus, Dengue Virus, and Chikungunya Virus prior to COVID-19), as well as vector control and agricultural products, all making use of their patented “CoPrimer” technology [7]
Date EUA Issued: 04/03/2020 [1]
Sources: [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13]
Organization: Dwight H. Egan (CEO); Brent Satterfield, PhD (CSO); Reed L. Benson (CSO) [6]
No. Tests Per Day: 93 tests/run x 1 run/1.5 hours x 24 hours/day= 1488 tests/day
Time to Result: 63-90 minutes time-to-detection, depending on PCR equipment used [10].
Test Sample Type: “nasopharyngeal and oropharyngeal swabs for upper respiratory system; bronchoalveolar lavage, sputum, and tracheal aspirate for lower respiratory system [2].”
Technology Overview: detects presence of RNA originating from SARS-CoV-2 in samples taken from upper or lower respiratory system [2]
Testing Type: qualitative viral RNA test, RT-PCR based [2]
Test Category: RT-PCR
Test Name: Logix Smart Coronavirus Disease 19 (COVID-19) 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: 12 years old, founded in 2008 [8]

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