3D Medicines Corporation

Business Name: 3D Medicines Corporation
Business Genre:
Business Description:

3D Medicines is a precision medicine company that helps patients with early and personalized diagnosis [2]. Based in China, this company uses “automated molecular diagnostics” and AI to help physician make tailored patient decisons and treatments [2].

City: Minghang
State: Shanghai
Country: China
Data/Evidence of Effectiveness: 100 out 111 clinical specimens tested using this kit met the requirement of qualilty control when evaulated against next generation sequencing [6]. The kit had 100% agreement when testing in parallel with the US CDC 2019-nCoV assay [6].
Complimentary Products Needed to Perform Test: ANDis 350 Automated Nucleic Acid Extraction System and ABI 7500 Real-Time PCR System [3]
Setting of Care: Presumably clinical settings
Current Status / Clinical Development Stage / Expected Milestones: Commercially available through Todos Medical in the New York Area and Israel [5].
LOD: 200 [9]
Funding & Ownership : Private; 950 Million Chinese Yuan or US$133.23 Million from venture funding [1].
Business Model: They provide next generation sequencing for oncology testing and diagnoses in China [7]. Also make hardware and software for nucleic acid extraction, detection and analysis [8].
IP: The kit doesn’t seem protected but the extraction machine is proprietary [5].
History & Origins : This company was the first to launch a fully enclosed automated NGS library prep system and had previous experience in clinical lab testing [2]. They leveraged those expertise to make SARS-CoV-2 detection kits in response to the outbreak [2].
Date EUA Issued: CE Certification on 3/17/2020 [4]. Entered review and approval phase for US FDA on 3/18/2020 but isn’t on the EUA website [5].
Sources: [1] [2] [3] [4] [5] [6] [7] [8] [9]
Organization: Founded by John Gong and Simon Shung [1].
No. Tests Per Day: N/A
Time to Result: Not found, but should be similar to other qPCR test.
Test Sample Type: Upper and lower respiratory specimens [3]
Technology Overview: Uses RT-qPCR to target sequences specific to SARS-CoV-2 with no cross reactivity SARS-CoV or MERS-CoV [3].
Testing Type: Qualitative RT-qPCR test for nucleic acids [3]
Test Category: RT-PCR
Test Name: ANDiS SARS-CoV-2 RT-qPCR Detection Kit [3]
Clinical Application & Need: Qualitative detection of SARS-Cov-2 RNA in specimens [3]
Age of Company: Founded in 2010 [1]

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