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

DiaSorin Molecular

Business Name:
DiaSorin Molecular
Business Genre:
Business Description:

DiaSorin Molecular LLC is focused on manufacturing and distributing molecular diagnostic products on the LIAISON MDX platform [2]. Their products help hospitals and reference labs to better manage patients with rapid clinical assay results [2].

City:
Cypress
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
100% positive and negative agreement on nasal swab, nasopharyngeal and BAL samples [2].
Complimentary Products Needed to Perform Test:
LIAISON MDX and Direct Amplification Disc [1]
Setting of Care:
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [3].
Current Status / Clinical Development Stage / Expected Milestones:
EUA approved and available for trial [2]
LOD:
242 (for nasal swab samples, which was their lowest LOD) [10]
Funding & Ownership :
Public, Annual Revenue – $763.6M [5], Market Cap – $10.32B [6]
Business Model:
Company partners with vendors to sell moelcular diagnostic services and products to hospitals and laboratories [2]
IP:
LIAISON is federally registered with the US Patent and Trademark office [7]
History & Origins :
The LIAISON MDX enables rapid thermocycling while their SImplexa line contains reagents for testing HSV 1 & 2, Flu A/B & RSV, Group A Strep, and C. difficile [2]. Therefore the company had previous experience with viral testing using RT PCR methods
Date EUA Issued:
03/19/2020 [4]
Sources:
[1] https://molecular.diasorin.com/us/kit/simplexa-covid-19-direct-kit/ [2] https://molecular.diasorin.com/us/about-us/ [3] https://www.fda.gov/media/136286/download [4] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [5] https://www.owler.com/company/diasorin [6] https://finance.yahoo.com/quote/DIA.MI?p=DIA.MI [7] https://molecular.diasorin.com/us/liaison-mdx/ [8] https://finance.yahoo.com/quote/DIA.MI/profile?p=DIA.MI [9]https://en.wikipedia.org/wiki/DiaSorin [10] https://www.fda.gov/media/136286/download
Organization:
CEO, GM & Exec Director – Carlo Rosa; CCO, Sr Corp VP of Commercial Operations & Exec Director – Chen Menachem Even; Corp Accounting Documents Officer, CFO & Sr. Corp VP – Piergiorgio Pedron; Sr. Director of Investor Relations & Corp Communication – Riccardo Fava; Mang. of the Corp. Legal Affairs Department – Marco Minolfo [8]
No. Tests Per Day:
24 * 24 = 576
Time to Result:
Little more than an hour [1].
Test Sample Type:
Nasal swab, nasopharyngeal swab, bronchoaveolar lavage (BAL) sample [1].
Technology Overview:
Paired with the LIAISON MDX system and Direct Amplification Disc, this kit eliminates the need for traditional nucleic acid extraction [1]
Testing Type:
Real-time RT-PCR System [3]
Test Category:
RT-PCR
Test Name:
Simplexa COVID-19 Direct
Clinical Application & Need:
In vitro qualitative detection of nucleic acids from SARS-CoV-2 [3].
Age of Company:
2000[9]

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