News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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New Fecal Occult Blood Testing Strategies for Colorectal Cancer Provide Labs with More Accuracy and Higher Profitability



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Media Contact: Ron Martin


AUSTIN, Texas (April 15, 2013) – Colorectal cancer (CRC), or cancer of the colon or rectum, is the second leading cause of cancer deaths in the U.S. According to the Centers for Disease Control and Prevention (CDC), about 140,000 Americans are diagnosed with CRC annually, and more than 50,000 people die as a result of the cancer.

There is a fairly simple and straightforward laboratory test available to detect for CRC. It is called the Fecal Occult Blood test (FOBT) and is recommended for everyone starting at age 50. For laboratories, tests for CRC are one of the most commonly requested and performed lab tests. There are two different types of FOBTs available to laboratories: chemical-based FOBT (CFOBT) and immunochemical FOBT (iFOBT). New iFOBTs have shown to have far fewer false positive results than CFOBTs, as well as far greater sensitivity.

Stephen Kincaid, owner of medical consulting firm SDK Instruments, Inc., (North Carolina), says, “Newer CRC testing modalities are more sensitive, more accurate, and can lead to better patient compliance and higher profitability for laboratories.”

The iFOBT has significant advantages over the CFOBT. The iFOBT detects human hemoglobin and is specific for blood in the lower G.I. tract instead of blood originating from other sources higher in the G.I. tract. The CFOBTs also have a high incidence of false negative results because of the presence of plant and animal materials in the colon.

In order to get the most accurate tests results, CFOBTs require patients to avoid certain foods, drugs, vitamins, and other substances for three to seven days prior to testing. As a result, pseudo-positive results remain as high as 30 percent and only 38 percent of patients in trials completed all planned tests – in order words, patient compliance is a major issues with the CFOBT.

The iFOBT does not require cleansing of the colon prior to testing and the sample can be collected at home. Hemosure’s iFOBT has greater than 87% sensitivity, able to detect as low as 50 ng HB/ml and is human hemoglobin specific. By comparison, traditional Guaiac tests offer only 50% sensitivity and detect 90,000 ng HB/ml or higher of non-specific hemoglobin. Traditional FOBT tests offer 86% accuracy, where the Hemosure iFOBT test offers greater than 97% accuracy.

“A fast, reliable and cost-effective FOBT platform is a necessity in today’s era of cost-conscious healthcare and the need for clinical laboratories to become more efficient,” says Robert L. Michel, Editor-In-Chief of The Dark Report. “As the Babyboomers age, they will increasingly need and demand quick and inexpensive screening tests for colorectal cancer and other cancers. At the same time, clinical laboratories and physicians are demanding easy-to-use laboratory tests that are as good or better than previous methodologies.”

The Dark Report is delighted to offer a recently published FREE White Paper that compares CFOBTs with iFOBTs, and looks at the cost effectiveness of the new technologies. It is titled, “Cleaning Up Your Medical Laboratory’s FOB Testing Program: New Opportunities for Better Patient Compliance, Increased Accuracy, and a Happier Staff.”   Published by The Dark Report  and Dark Daily,  it is available free to laboratory professionals as a PDF download.

Along with other topics, this FREE White Paper specifically addresses:

• A comparison of false negative results between CFOBT and iFOBT

• An evaluation of the various FOBT platforms’ sensitivity and efficacy

• A cost comparison and discussion of Medicare reimbursement between the two modalities

• Case studies in which laboratories and institutions’ use of iFOBT led to positive financial performance and greater customer returns

The paper’s editor, author, Stephen Kincaid, owns and operates SDK Instruments, Inc., a medical consultation company in North Carolina. He has more than 40 years experience in the clinical laboratory field. Having served as an FDA consultant to Mindray Electronics, Inc., he currently serves as a technical resource and eastern regional manager for Hemosure, Inc.

This White Paper, “Cleaning Up Your Medical Laboratory’s FOB Testing Program: New Opportunities for Better Patient Compliance, Increased Accuracy, and a Happier Staff,” is available for free download as a PDF at It is part of the Dark Daily Resource Center, which has a growing library of White Papers  and other information resources tailored specifically for the needs of laboratory administrators, lab managers, pathologists, and lab industry consultants.

For additional information, Contact: Ron Martin, 512-264-7103


Established in 1995, THE DARK REPORT  is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely-read by leaders in laboratory medicine and diagnostics. The DARK REPORT produces the famous Executive War College on Laboratory and Pathology Management (every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals), Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.