Business Name: QuantuMDx
Business Genre:
Business Description:

QuantuMDx is a venture funded company that is trying to develop a protable machine that performs diagnostics in 30 minutes. [1]

State: Newcastle
Country: United Kingdom
Data/Evidence of Effectiveness: “• Inclusivity: “Sequences for the SARS-CoV-2 virus were downloaded from the NCBI and GISAID. The downloading and vetting of the SARS-CoV-2 sequence data occurred on 15 Apr 2020 with a resulting 10,151 sequences (1,022 = NCBI and 9,126 = GISAID) utilized for inclusivity analysis.” • Cross-reactivity: in silico analysis only • Interfering substances were analyzed • Clinical validation: Results were concordant across 89/90 samples. SARS-CoV-2 positive (n=60) and negative (n=29). (sensitivity of 100% and a specificity of 96.77%) [5] “
Complimentary Products Needed to Perform Test: “• Positive (Twist Synthetic SARS-CoV-2 RNA Control 2) and negative controls • RNA Extraction Kit (Qiagen QIAamp Viral RNA Mini Kit) • RT-PCR machine (Qiagen Rotor-Gene Q and BioRad CFX96 Dx) • Laboratory supplies: centrifuge, vortex, reagent troughs, 96 well plates, and film cover [5]”
Setting of Care: “””Testing with the QuantuMDx SARS-CoV-2 Detection Assay is intended for use by trained laboratorians who are proficient in performing molecular based tests.”” [5]”
Current Status / Clinical Development Stage / Expected Milestones: They recently applied for an EUA and are waiting for a response. [5] The BALSA Group suspects but cannot be certain that they want to modify this test to work with their Q-POC system.
Funding & Ownership : Their lead investor is the Helsinn Investment Fund [6]
Business Model: They were founded in 2008 and are currently being funded by venture. [6]
IP: QuantuMDx has patents for its microfluidic cassette called “Fabrication and use of a microfluidics multitemperature flexible reaction device”[2] and “Improved target cell concentration using dielectrophoresis (dep)” [3]
History & Origins : They were founded in 2008 and are still trying to develop their Q-POC device. [1]
Date EUA Issued: “Our SARS-CoV-2 assay has been CE-IVD marked under the in vitro Diagnostics Directive (98/79/EC). We have also applied to the US Food and Drug Administration (FDA) for Emergency Use Authorisation.” [5]
Sources: [1] [2] [3] [4] [5] [6]
Organization: Founder and CEO: Jonathan O’Halloran
No. Tests Per Day: 24 hours/day / 4 hour runs = 6 runs/day. 94 samples/plate x 6 runs/day = 564 samples/day
Time to Result: Not stated, but likely 3-4 hours since it is a QPCR test.
Test Sample Type: Upper respiratory specimens (e.g. nasopharyngeal or oropharyngeal swabs, etc.) [5]
Technology Overview: RT-PCR test that uses Taqman primers against Orf1, N-gene, and S-gene (all FAM), and RNAse P as internal control (HEX) [5]
Testing Type: Qualitative viral RNA test [4]
Test Category: RT-PCR
Test Name: SARS-CoV-2 RT-PCR
Clinical Application & Need: acute infection [4]
Age of Company: 2008 [6]

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