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

Orig3n, Inc.

Business Name:
Orig3n, Inc.
Business Genre:
Business Description:

Offers a line of DNA tests to help people ‘understand more about your mind and body’ to detect certain genes, utilizes induced pluripotent stem (iPS) cells to develop treatments for damaged organs or tissues [3]

City:
Boston
State:
MA
Country:
USA
Data/Evidence of Effectiveness:
LOD is 5 copies/uL. Tested on contrived samples (positive n=90, negative n=30) and verified LOD. [7]
Complimentary Products Needed to Perform Test:
No kit available. Tests will provide swab and other containers that then must be mailed in [6]
Setting of Care:
LDT (laboratory-developed test) only authorized for use in Orig3n [1]
Current Status / Clinical Development Stage / Expected Milestones:
Labs are running for diagnosis of tests, lab processes hundreds of thousands of tests for the company every year [6]
Funding & Ownership :
privately owned [5]
Business Model:
Produce and sell genetic tests for the average person to learn about their genes, such as the ‘superhero’ test or the ‘intelligence’ test. [3] [4]
IP:
tech is proprietary and copyrighted [3]
History & Origins :
Produces genetic tests to detect certain genes at home and custom vitamins, no evident history of qPCR assays [4]
Date EUA Issued:
04/10/2020 [1]
Sources:
[1] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [2] https://orig3n.com/contact/ [3] https://orig3n.com/our-mission/ [4] https://shop.orig3n.com/ [5] https://www.crunchbase.com/organization/orig3n#section-overview [6] https://orig3n.com/covid19/ [7] https://www.fda.gov/media/136873/download
Organization:
COO: Kate Blanchard. CEO: Robin Smith [5]
Time to Result:
4+ days [6]
Test Sample Type:
oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab [6]
Technology Overview:
Testing only available in the Orig3n laboratory in Boston, MA. Samples are sent in and results are produced 24-36hours after receipt of sample. Targets the N gene. [6] [7]
Testing Type:
RT-PCR [6]
Test Category:
RT-PCR
Test Name:
Orig3n 2019 Novel Coronavirus (COVID-19) Test [1]
Clinical Application & Need:
detect current infection from oropharyngeal, nasopharyngeal, anterior nasal, and mid-turbinate nasal swab specimens [6]

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