Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population

Jimmy Bok Yan So ^1,2,3, Ritika Kapoor ⁴, Feng Zhu ⁵

¹Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
²Division of Surgical Oncology, National University Cancer Institute, Singapore.
³Department of Surgery, National University Hospital, Singapore.
⁴Graduate School for Integrative Sciences and Engineering, National University of Singapore, Singapore.
⁵Department of Medicine, Yong Loo Lin School of Medicine, National University Singapore, Singapore.
⁶Department of Gastroenterology and Hepatology, National University Hospital, Singapore.
⁷Department of Research and Development, MiRXES Lab, Singapore.
⁸Diagnostics Development Hub, Accelerate Technologies Pte Ltd, Agency for Science Technology and Research, Singapore.
⁹Yonsei Cancer Center, Songdang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, Republic of Korea.
¹⁰Saw Swee Hock School of Public Health, National University of Singapore, Singapore.
¹¹Department of Physiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
¹²Department of Surgery, Tan Tock Seng Hospital, Singapore.
¹³Department of Gastroenterology and Hepatology, Tan Tock Seng Hospital, Singapore.
¹⁴Singapore Immunology Network, Agency for Science Technology and Research, Singapore.
¹⁵Department of Haematology-Oncology, National University Cancer Institute, Singapore.
¹⁶Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
¹⁷Department of Medicine, Yong Loo Lin School of Medicine, National University Singapore, Singapore mdcykg@nus.edu.sg.
¹⁸Singapore Gastric Cancer Consortium, Singapore.

⁰Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

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October 8, 2020

View abstract on PubMed

Summary

A new 12-microRNA (miRNA) serum assay aids gastric cancer diagnosis in high-risk individuals. This non-invasive test shows promise as a cost-effective screening tool compared to existing methods.

Area Of Science

Biomarkers
Oncology
Molecular Diagnostics

Background

Gastric cancer diagnosis lacks non-invasive biomarkers.
Early detection is crucial for improving patient outcomes.
Current diagnostic methods can be invasive or have limitations.

Purpose Of The Study

To develop and validate a serum microRNA (miRNA) panel for non-invasive gastric cancer detection.
To assess the diagnostic performance of the miRNA panel in a high-risk population.
To evaluate the cost-effectiveness of the developed assay for gastric cancer screening.

Main Methods

A multicentre study involving over 5000 subjects from Singapore and Korea.
Serum miRNA profiling and multivariant analysis for biomarker discovery and verification.
Prospective validation of a 12-miRNA clinical assay in symptomatic individuals undergoing endoscopy.

Main Results

The 12-miRNA panel demonstrated high diagnostic accuracy (AUC=0.93 in discovery, 0.92 in verification).
In prospective validation, the assay achieved 87.0% sensitivity and 68.4% specificity (AUC=0.848).
The assay outperformed existing biomarkers like HP serology, PGs, CEA, and CA19-9 and was found to be cost-effective.

Conclusions

A validated serum 12-miRNA biomarker assay can aid in non-invasive gastric cancer risk assessment.
This assay offers a potentially cost-effective screening strategy for gastric cancer.
Further implementation could improve early detection and management of gastric cancer.

Keywords:

gastric cancer screening