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Invention and clinical trial of in vitro diagnostic (IVD) tests for depression diagnosis

Invention and clinical trial of in vitro diagnostic (IVD) tests for depression diagnosis

June 23, 2025

Dr. Yao Honghong first began researching Circular RNA in the United States in 2008. Later, in 2016, she led a research team at Southeast University in Nanjing to advance studies on circular RNA technology. By 2019, her team conducted experiments on mice with depression, screening over 20,000 genes to identify four highly expressed Circular RNA biomarkers associated with the condition. This was no small feat—the team progressively narrowed down candidates from 20,000 to 3,000, then to 1,000, then 200, and finally to the four key genes, a process that took nearly three years. 

 

Following this breakthrough, the team obtained gene sequence data through next-generation sequencing (NGS) and developed specific primers, ultimately completing the development of an RT-PCR detection kit for depression. 

 

The clinical trials for the "Major Depressive Disorder (MDD) CircRNA RT-PCR Detection Kit"(Clinical Trial 467 cases) are being led by Professor Yao Honghong from Southeast University’s School of Medicine from March 2023 to June 2024. Collaborating institutions include: 

- Zhongda Hospital Affiliated to Southeast University, 

- Huzhou Third People’s Hospital, and 

  • Huaian Third People’s Hospital.

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