Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)

Business Name: Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)
Business Description:

Global diagnostic technology supplier, with tests used in 60+ countries. Designs and manufactures infectious disease detection kits which can differentiate between viral, bacterial, and other infections via syndromic multiplex real time PCR. [3] Acquired by Siemens Healthineers Dec 15, 2017 [3].

City: Sliema
State: NA
Data/Evidence of Effectiveness: Health provider fact sheet states that while the test has been designed to reduce likelihood of false positive results, both false positive and false negative results are possible. Consideration of COVID-19 exposure and associated symptoms are recommended as secondary considerations to the test result. [4] Kit contains positive, negative, and internal controls, and an external RNA positive control is recommended (ex: AccuPlex™ SARS-CoV-2 Reference Material Kit (Material number 0505-0126)) [5]. Reported “100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity.” [7]
Complimentary Products Needed to Perform Test: SCoV2 PP Mix 96 (positive control, double-stranded DNA from target genomic regions), SCoV2 PC 96, Negative Ctrl 96 (nuclease-free molecular-grade water), Internal Ctrl 96 (Equine arteritis virus), 25x RT-PCR Enz. 96 and 2x RT-PCR Buff. 96 [2]
Current Status / Clinical Development Stage / Expected Milestones: Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2]. Currently available for purchase [6]
LOD: 0.0023 TCID50/mL [5] x 53,797 copies/TCID50 (assumed from Rhinovirus copies/TCID50 [12])=123.7 copies/mL
Funding & Ownership : Private: M&A funding status [3]. Acquired by Siemens Healthineers Dec. 15, 2017 for an undisclosed amount [3].
Business Model: Design and produce infectious disease detection kits [3], sold directly by Fast Track Diagnostics/Siemens Healthineers [6].
History & Origins : Company specializes in infectious disease detection technologies, with products in use in 60+ countries.[3]
Date EUA Issued: 05/05/2020[1]
Sources: [1] [2] [3] [4] [5] [6] [7],-now-ce-ivd-registered/ [8]
Organization: Bill Carman (CEO)
No. Tests Per Day: 93wells x (24hr per day/1hr per test) = 2,232 tests/day
Time to Result: results available ~1 hour after beginning RT-PCR [5]. Overall testing process takes several hours and specialized equipment[8].
Test Sample Type: nasal, nasopharyngeal, oropharyngeal swabs; nasopharyngeal wash/aspirate; bronchoalveolar lavage [2]
Technology Overview: detects presence of RNA originating from SARS-CoV-2 within the upper respiratory system [2, 5]
Testing Type: qualitative viral RNA test, RT-PCR based [2, 5]
Test Category: RT-PCR
Test Name: FTD SARS-CoV-2 [2]
Clinical Application & Need: A positive result indicates the patient is actively infected with the virus, and assumed to be contagious[4]
Age of Company: 13 years old, founded in 2007 [3]

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