Am J Cancer Res 2012;2(5):598-605

Original Article
A multiplex serum protein assay for determining the probability of colorectal
cancer

Randall Brock, Bob Xiong, Lily Li, Ruth A VanBogelen, Lori Christman

Onconome, Inc. Redmond, WA USA; Tandem Labs, Woburn, MA USA; Consultant, Woburn, MA USA; Biomarker Science Group,
Manchester, MI USA; STATKING Consulting, Inc. Fairfield, OH, USA

Received May 10, 2012; accepted June 11, 2012; Epub August 20, 2012; Published September 15, 2012

Abstract: Our purpose is to develop a serum assay to determine an individual’s probability of having colorectal cancer (CRC).
We have discovered a protein panel yielding encouraging, clinically significant results. We evaluated 431 serum samples from
donors screened for CRC by colonoscopy. We compared the concentration of seven proteins in individuals with CRC versus
individuals found to be CRC free. The assay monitored a single peptide from each of seven proteins. Comparing CRC to normal
samples in univariate two-sample t-tests, 6 of the 7 proteins yielded a p-value less than 0.01. Logistic regression was used to
construct a model for determination of CRC probability. The model was fit on a randomly chosen training set of 321 samples.
Using 6 of the 7 proteins (ORM1, GSN, C9, HABP2, SAA2, and C3) and a cut point of 0.4, an independent test set of 110 samples
yielded a sensitivity of 93.75%, a specificity of 82.89% and a prevalence-adjusted negative predictive value (NPV) of 99.9775% for
the assay. The results demonstrate that the assay has promise as a sensitive, non-invasive diagnostic test to provide
individuals with an understanding of their own probability of having CRC. (AJCR0000122).

Keywords: Colon cancer, proteomics, cancer, colon, mass spec, MRM, colorectal, CRC


Address all correspondence to:
Dr. Randall Brock
15385 NE 90th Street
Redmond, WA 98052, USA.
Tel: (425) 284-4390 ex 314; Fax: (425) 284-4396
E-mail: rbrock@onconome.com
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American Journal of Cancer Research
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