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Sci Rep. 2017 Jun 8;7(1):3032. doi: 10.1038/s41598-017-03321-8.

The performance of the SEPT9 gene methylation assay and a comparison with other CRC screening tests: A meta-analysis.

Song L1,2, Jia J3,4, Peng X5,6, Xiao W6, Li Y7.

Author information

1
Department of Radiotherapy, The Chinese PLA 309th Hospital, Beijing, 100091, P.R. China. songlele@sina.com.
2
BioChain (Beijing) Science and Technology, Inc., Beijing, 100176, P.R. China. songlele@sina.com.
3
Department of Radiotherapy, The Chinese PLA 309th Hospital, Beijing, 100091, P.R. China.
4
Department of Graduate, Hebei North University, Zhangjiakou, Hebei, P.R. China.
5
Medical School of Chinese PLA and Chinese PLA General Hospital, Beijing, P.R. China.
6
Department of Oncology, First Affiliated Hospital of Chinese PLA General Hospital, Beijing, P.R. China.
7
Department of Radiotherapy, The Chinese PLA 309th Hospital, Beijing, 100091, P.R. China. liyuemin224@sina.com.

Abstract

The SEPT9 gene methylation assay is the first FDA-approved blood assay for colorectal cancer (CRC) screening. Fecal immunochemical test (FIT), FIT-DNA test and CEA assay are also in vitro diagnostic (IVD) tests used in CRC screening. This meta-analysis aims to review the SEPT9 assay performance and compare it with other IVD CRC screening tests. By searching the Ovid MEDLINE, EMBASE, CBMdisc and CJFD database, 25 out of 180 studies were identified to report the SEPT9 assay performance. 2613 CRC cases and 6030 controls were included, and sensitivity and specificity were used to evaluate its performance at various algorithms. 1/3 algorithm exhibited the best sensitivity while 2/3 and 1/1 algorithm exhibited the best balance between sensitivity and specificity. The performance of the blood SEPT9 assay is superior to that of the serum protein markers and the FIT test in symptomatic population, while appeared to be less potent than FIT and FIT-DNA tests in asymptomatic population. In conclusion, 1/3 algorithm is recommended for CRC screening, and 2/3 or 1/1 algorithms are suitable for early detection for diagnostic purpose. The SEPT9 assay exhibited better performance in symptomatic population than in asymptomatic population.

PMID:
28596563
PMCID:
PMC5465203
DOI:
10.1038/s41598-017-03321-8
[Indexed for MEDLINE]
Free PMC Article

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