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

Luminex Corp

Business Name: Luminex Corp
Business Genre:
Business Description:

The company developed products for biological testing including genetic analysis and drug discovery. The company has been known for its development of xMAP technology, an open-architecture platform can be applied to various testing. [1]

State: TX
Country: USA
Data/Evidence of Effectiveness: FDA Sensitivity Evaluation indicates the limit of detection ( over 95% hit rate) is 5.48E-02 TCID50/ml. Clinical performance was evaluated by 30 positive samples with 2x/3x/5x LoD. The positive/negative result agreement is 100% [3]
Complimentary Products Needed to Perform Test: Reagents for sample collection [3]
Setting of Care: permitted use under EUA in authorized laboratories [3]
Current Status / Clinical Development Stage / Expected Milestones: The company claimed hundreds of labs across US were equipped with their ARIES® System. The company also claimed a manufacture capacity to produce up to 200,000 ARIES® SARS-CoV-2 tests per month in April. [5]
Funding & Ownership : Public (Market Cap $1.36B) [7]
Business Model: The company focuses on the development of biological technology for fast testing and analysis. The company designed several open-architecture systems for multiplexed assays, including xMAP® technology for biomarker detection, xTAG® technology for nucleic acid assays and MultiCode®-RTx technology for PCR-based assays. [6]
IP: Several patents related to ARIES® system, like systems and methods for multiplex analysis of PCR in real time (US7955802B2)
History & Origins : The fully automated ARIES® Systems designed by Luminex provides sample-to-answer solutions for PCR-based diagnostics. The integrated open architecture system supported the development of CoV-19 testing. [4]
Date EUA Issued: 04/03/2020 [2]
Sources: [1] https://investor.luminexcorp.com/corporate-profile [2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [3] https://www.fda.gov/media/136693/download [4] https://www.luminexcorp.com/aries/ [5] https://news.yahoo.com/luminex-receives-fda-emergency-authorization-113000184.html [6] https://www.luminexcorp.com/our-technology/ [7] https://www.msn.com/en-us/money/stockdetails/fi-a1wzhw [8] https://www.luminexcorp.com/leadership/
Organization: Nachum “Homi” Shamir (President and Chief Executive Officer) [8]
Time to Result: 12 samples in less than 2 hours, 48 results in 8 hours [4]
Test Sample Type: Nasopharyngeal swab (flocked or polyester swab) sample [3]
Technology Overview: PCR amplification for CovV-19 ORF1ab and N genes [3]
Testing Type: nucleic acid detection
Test Category: RT-PCR
Test Name: ARIES® SARS-CoV-2 Assay
Clinical Application & Need: acute infection

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