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] [2] [3] [4] [5] [6] [7] [8] [9] [10]
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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