3D Medicines Corp (3DMed)

3D Medicines (3DMed), founded in 2010, is a leader in precision medicine in China dedicated to making early and personalized diagnosis accessible to each patient.

3DMed set the standard of innovation in automated molecular diagnostics and artificial intelligence (AI) to help physicians leverage genetic information to tailor treatment to individual patients.

3DMed clinical laboratory is accredited by College of American Pathologists (CAP) and certified by Clinical Laboratory Improvement Amendments (CLIA) to provide clinical testing in various disease areas.

In 2018, 3DMed introduced an AI-based cancer genome data interpretation system, the ANDiS Genome Insight. In late 2019, 3DMed launched the world’s first fully closed automated NGS library-prep system, the ANDiS 400. 3DMed aspires to be a game changer by offering a diverse pipeline of automated molecular diagnostics.

Soon after the coronavirus 2019 (COVID-2019) outbreak, 3DMed responded rapidly by developing a series of RT-qPCR-based tests (the ANDiS SARS-CoV-2 Detection Kit and the ANDiS SARS-CoV-2 & Influenza A/B Detection Kit) for qualitative detection of SARS-CoV-2 RNA in upper and lower respiratory specimens collected from individuals who meet the CDC criteria for SARS-CoV-2 testing.

LDT BUSINESS
3DMed Clinical Laboratory
3DMed clinical laboratory was established in October 2015, mainly focusing on molecular diagnostic in terms of laboratory developed test (LDT) business.
Since its establishment, the laboratory has always adhered to the principle of quality first, and established a laboratory quality management system in accordance with international standards such as the College of American Pathologists (CAP) and ISO15189. Since 2016, it has passed the external quality assessment（EQA）of international (CAP and EMQN) and domestic (National Health Commission and Shanghai Center for Clinical laboratory) for 50 consecutive times. The laboratory passed the CAP on-site review on December 7, 2017, and passed the CLIA certification on May 22, 2019, which indicates that the quality system and the reports issued by 3DMed clinical laboratory have been recognized globally.

IVD BUSINESS
Instruments:
*ANDiS 350 Automated Nucleic Acid Extraction System
*ANDiS 400 Automated Closed Library Prep System
Reagents:
*Nucleic Acid Extraction
*SARS-CoV-2 Test
*Library Prep Cassette
Software:
*TINA (Test Information Management Platform)
Solutions:
*ANDiS NGS Intelligent Solution
- ANDiS 350 Nucleic Acid Extraction
- ANDiS 400 Library Preparation
- Sequencer Sequencing
- TINA Variant analysis, annotation and report
*Integrated Solution of SARS-CoV-2 Detection
- Specimens
- ANDiS 350 Nucleic Acid Extraction system
- Real-Time qPCR system
- about 500 tests/6hrs (5 runs)