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

Trax Management Service, Inc

Business Name:
Trax Management Service, Inc
Business Genre:
Business Description:

Trax Management Service is a Service-Disabled Veteran Owned Small Business (“SDVOSB”) medical logistics company [2]

City:
Delaware
State:
OH
Country:
USA
Data/Evidence of Effectiveness:
Limit of detection of the kit is 100 copies/ml with different extraction kits and PCR instruments. No cross-reactivity was detected according to in silico experiments. The company also tested the clinical performance of the kit with different sample collecting methods and extraction kits. Both positive and negative samples were 100% agreed with the testing results. [4]
Complimentary Products Needed to Perform Test:
RNA extraction kit, RT-PCR instruments [4]
Setting of Care:
permitted use under EUA in authorized laboratories [4]
Current Status / Clinical Development Stage / Expected Milestones:
The kit is sold by a biotech company called Procomcure Biotech and manufactured in Austria. The company reported a production capacity of one million tests per week and 15 days from purchase to delivery. [2]
Funding & Ownership :
Service-Disabled Veteran Owned Small Business (“SDVOSB”) [2]
Business Model:
Information of this company is quite limited. The company connects global suppliers to provide biomedical solutions for clinical demand. There is no report of other biomedical diagnostics products designed/manufactured by the company.[2]
IP:
N/A
History & Origins :
The company collaborated with an Austrian biotech lab with 25-year experiences in developing diagnostics kits. [2]
Date EUA Issued:
04/20/2020 [3]
Sources:
[1] https://www.fda.gov/media/137150/download [2] https://www.prnewswire.com/news-releases/service-disabled-veteran-owned-small-business-sdvosb-medical-logistics-company-brings-fda-eua-covid19-test-to-north-america-301050741.html [3] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [4] https://www.fda.gov/media/137153/download
Organization:
Rakan Qazziha (Chief Science Officer) [2]
Time to Result:
96 outputs on ABI 7500 platform in 3.5 hours
Test Sample Type:
nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens [4]
Technology Overview:
PCR amplification for SARS-CoV-2 E gene and RdPR gene [4]
Testing Type:
nucleic acid detection
Test Category:
RT-PCR
Test Name:
PhoenixDx 2019-CoV
Clinical Application & Need:
acute infection

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