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

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

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Regenstrief Institute Finds Fecal Immunochemical Test May Be as Effective as Colonoscopy at Detecting Colorectal Cancers

Doctors may begin ordering FITs in greater numbers, increasing the demand on clinical laboratories to process these home tests

All clinical laboratory managers and pathologists know that timely screening for colon cancer is an effective way to detect cancer early, when it is easiest to treat. But, invasive diagnostic approaches such as colonoscopies are not popular with consumers. Now comes news of a large-scale study that indicates the non-invasive fecal immunochemical test (FIT) can be as effective as a colonoscopy when screening for colon cancer.

FITs performed annually may be as effective as colonoscopies at detecting colorectal cancer (CRC) for those at average risk of developing the disease. That’s the conclusion of a study conducted at the Regenstrief Institute, a private, non-profit research organization affiliated with the Indiana University School of Medicine in Indianapolis, Ind.

The researchers published their findings in the Annals of Internal Medicine (AIM), a journal published by the American College of Physicians (ACP). The team reviewed data from 31 previous studies. They then analyzed the test results from more than 120,000 average-risk patients who took a FIT and then had a colonoscopy. After comparing the results between the two tests, the researchers concluded that the FIT is a sufficient screening tool for colon cancer.

FIT is Easy, Safe, and Inexpensive

As a medical laboratory test, the FIT is low risk, non-invasive, and inexpensive. In addition, the FIT can detect most cancers in the first application, according to the Regenstrief Institute researchers. They recommend that the FIT be performed on an annual basis for people at average risk for getting colorectal cancers.

“This non-invasive test for colon cancer screening is available for average risk people,” Imperiale told NBC News. “They should discuss with their providers whether it is appropriate for them.”

FIT is performed in the privacy of the patient’s home. To use the test, an individual collects a bowel specimen in a receptacle provided in a FIT kit. They then send the specimen to a clinical laboratory for evaluation. The FIT requires no special preparations and medicines and food do not interfere with the test results.

Thomas Imperiale, MD (above), is a Lawrence Lumeng Professor of Gastroenterology and Hepatology at Indiana University School of Medicine, and a research scientist at the Regenstrief Institute. He led a study which concluded that FITs are as effective as colonoscopies at detecting cancer in average risk patient populations. Should these conclusions become widely accepted, doctors may begin ordering FITs in greater numbers, increasing the demand on clinical laboratories that process the tests. (Photo copyright: Indiana University School of Medicine.)

‘A Preventative Health Success Story’

The FIT can be calibrated to different sensitivities at the lab when determining results. Imperiale and his team found that 95% of cancers were detected when the FIT was set to a higher sensitivity, however, that setting resulted in 10% false positives. At lower sensitivity the FIT produced fewer false positives (5%), but also caught fewer cancers (75%). However, when the FIT was performed every year, the cancer detection rate was similar at both sensitivities over a two-year period.

“FIT is an excellent option for colon cancer screening only if it is performed consistently on a yearly basis,” Felice Schnoll-Sussman, MD, told NBC News. Sussman is a gastroenterologist and Professor of Clinical Medicine at Weill Cornell Medicine. “Colon cancer screening and its impact on decreasing rates of colon cancer is a preventative health success story, although we have a way to go to increase rates to our previous desired goal of 80% screened in the US by 2018.”

The FIT looks for hidden blood in the stool by detecting protein hemoglobin found in red blood cells. A normal result indicates that FIT did not detect any blood in the stool and the test should be repeated annually. If the FIT comes back positive for blood in the stool, other tests, such as a sigmoidoscopy or colonoscopy should be performed. Cancers in the colon may not always bleed and the FIT only detects blood from the lower intestines.

Patients are Skipping the Colonoscopy

Approximately 35% of individuals who should be receiving colonoscopies do not undergo the test, NBC News noted. The American Cancer Society (ACS) lists the top five reasons people don’t get screened for colorectal cancer are that they:

  • fear the test will be difficult or painful;
  • have no family history of the disease and feel testing is unnecessary;
  • have no symptoms and think screening is only for those with symptoms;
  • are concerned about the costs associated with screening; and
  • they are concerned about the complexities of taking the tests, including taking time off from work, transportation after the procedure, and high out-of-pocket expenses.

“Colorectal cancer screening is one of the best opportunities to prevent cancer or diagnose it early, when it’s most treatable,” Richard Wender, MD, Chief Cancer Control Officer for the ACS stated in a press release. “Despite this compelling reason to be screened, many people either have never had a colorectal cancer screening test or are not up to date with screening.”

Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The ACS estimates there will be 101,420 new cases of colon cancer and 44,180 new cases of rectal cancer diagnosed this year. The disease is expected to be responsible for approximately 51,020 deaths in 2019.

New cases of the disease have been steadily decreasing over the past few decades in most age populations, primarily due to early screening. However, the overall death rate among people younger than age 55 has increased 1% per year between 2007 and 2016. The ACS estimates there are now more than one million colorectal cancer survivors living in the US.

The ACS recommends that average-risk individuals start regular colorectal cancer screenings at age 45. The five-year survival rate for colon cancer patients is 90% when there is no sign that the cancer has spread outside the colon.

Clinical laboratory professionals may find it unpleasant to test FIT specimens. Opening the specimen containers and extracting the samples can be messy and malodorous. However, FITs are essential, critical tests that can save many lives.

—JP Schlingman

Related Information:

Annual Stool Test May Be as Effective as Colonoscopy, Study Finds

Top Five Reasons People Don’t Get Screened for Colorectal Cancer

About Colorectal Cancer

Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps: A Systematic Review and Meta-analysis

Clinical Pathology Laboratory Managers Use Lessons in the Best of Medical Laboratory Quality to Improve Lab Operations and Patient Safety

Nation’s largest gathering of clinical laboratory Lean, Six Sigma, and process improvement practitioners took place in New Orleans this week

DATELINE: NEW ORLEANS, LOUISIANA—More than 300 of the nation’s leading quality improvement practitioners in clinical laboratory operations came together this week to share, learn, and master the best approaches to improving the quality of medical laboratory operations in ways that improve performance and productivity even while delivering substantial reductions in cost.

The opening session of the Ninth Annual Laboratory Quality Confab featured three clinical laboratories that have aggressively used quality management methods, including Lean and Six Sigma. These are labs that are strategically committed to creating and sustaining a culture of quality and continuous process improvement. (more…)

Health Insurers Encourage Physicians to Help Patients Use Cost and Quality Data to Select Providers, Including Medical Laboratories

Employers and health insurers want more consumers use healthcare cost estimator tools and pride when choosing a hospital, physician, or clinical laboratory

Having put millions of consumers into high-deductible health plans (HDHPs) as one way to control healthcare costs, both employers and health insurers are now challenged to help these same consumers do better at using price and quality factors when selecting providers.

One solution to this problem is to encourage physicians to play a greater role in helping their patients use price and quality when it is time to select a provider. Obviously, these decisions can involve which clinical laboratory or anatomic pathology practice a patient should select when he or she needs medical laboratory testing.

(more…)

Physician-Led Accountable Care Organizations May Offer Advantages for Clinical Laboratories

Last year, hospital-run ACOs outnumbered physician-led ACOs, but this year, the opposite is true, creating opportunities for pathologists and clinical laboratories

Until recently, the popular wisdom was that hospitals and health systems would tend to play dominant roles in most accountable care organizations (ACOs). However, new data shows that physicians are holding their own in the formation and management of ACOs.

This is an auspicious development for local clinical laboratories and pathology groups. Physician-run ACOs are much more likely to consider using an independent medical laboratory provider. (more…)

University of Michigan Study Predicts that Majority of Physician Practices Will Lose Money on their EHR Systems

Research study shows opportunity for clinical laboratories to help client physicians get more value from their electronic health record systems

For the majority of physicians in the United States, implementation of an electronic health record (EHRs) system in their practice may turn out to be a money-losing proposition. That is one prediction made by researchers at the University of Michigan (UM), based on a study they conducted.

Among other things, these findings indicate that progressive clinical laboratories and pathology groups have the opportunity to leverage the interface between their laboratory information system (LIS) and the client physician’s EHR to deliver added value. That’s because pathologists, Ph.D.s, and laboratory scientists know many ways that physicians can improve how they order medical laboratory tests and act upon the results of those tests.

(more…)

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