A case-controlled validation study of a blood-based seven-gene biomarker panel for colorectal cancer in Malaysia.
BACKGROUND
Colorectal cancer (CRC) screening is key to CRC prevention and mortality reduction, but patient compliance with CRC screening is low. We previously reported a blood-based test for CRC that utilizes a seven-gene panel of biomarkers. The test is currently utilized clinically in North America for CRC risk stratification in the average-risk North American population in order to improve screening compliance and to enhance clinical decision making.


METHODS
In this study, conducted in Malaysia, we evaluated the seven-gene biomarker panel validated in a North American population using blood samples collected from local patients. The panel employs quantitative RT-PCR (qRT-PCR) to analyze gene expression of the seven biomarkers (ANXA3, CLEC4D, TNFAIP6, LMNB1, PRRG4, VNN1 and IL2RB) that are differentially expressed in CRC patients as compared with controls. Blood samples from 210 patients (99 CRC and 111 controls) were collected, and total blood RNA was isolated and subjected to quantitative RT-PCR and data analysis.


RESULTS
The logistic regression analysis of seven-gene panel has an area under the curve (AUC) of 0.76 (95% confidence interval: 0.70 to 0.82), 77% specificity, 61% sensitivity and 70% accuracy, comparable to the data obtained from the North American investigation of the same biomarker panel.


CONCLUSIONS
Our results independently confirm the results of the study conducted in North America and demonstrate the ability of the seven biomarker panel to discriminate CRC from controls in blood samples drawn from a Malaysian population.
Yip
Kok-Thye
KT
Research Department, GeneNews Ltd, 2 East Beaver Creek Road, Building 2, Richmond Hill, Ontario, L4B 2N3, Canada.
Das
Prashanta K
PK
Suria
David
D
Lim
Chun-Ren
CR
Ng
Guey-Hooi
GH
Liew
Choong-Chin
CC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D015179:Colorectal Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000208:ethnology / Q000235:genetics*; D005260:Female; D015972:Gene Expression Regulation, Neoplastic; D005820:Genetic Testing; D006801:Humans; D016015:Logistic Models; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D011237:Predictive Value of Tests; D012313:RNA / Q000097:blood*; D012372:ROC Curve; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D018570:Risk Assessment; D012307:Risk Factors; D012680:Sensitivity and Specificity
D012313:RNA