Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

Fecal Immunochemical Test (FIT) for colorectal cancer screening compared to CRC screening with Guaiac –based fecal occult blood test (gFOBT) in the screening of Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC). in healthy and/or asymptomatic adults and elderly Any adult over 50 years old, both men and women, with average risk of CRC.

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Mirjana Huic (AAZ), Agnes Männik (UTA - Estonia), Jesus Gonzalez (ISCIII - Spain), Ingrid Rosian (GÖG - Austria), Gottfried Endel (HVB - Austria), Valentina Rupel (IER - Slovenia), Alessandra Lo Scalzo (Agenas - Italy), Ingrid Wilbacher (HVB - Austria)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), AETSA (Spain), A. Gemelli (Italy), Avalia-t (Spain), CEIS (Italy), CEM (Luxembourg), GÖG (Austria), HAS (France), HVB (Austria), IER (Slovenia), ISCIII (Spain), Laziosanità (Italy), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), Osteba (Spain), Regione Veneto (Italy), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
5.4.2013 13.07.00
31.7.2014 9.21.00
Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 19 September 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening

<< Health Problem and Current Use of the TechnologySafety >>

Description and technical characteristics of technology

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cristian Vladescu

Summary

Aim To describe and review the technical characteristics of iFOBT.

Methods The Project scope is applied in this Domain. Results cards are covered by evidence gathered from basic literature search, hand searched literature, manufacturers web sites, company brochures and information for use, and survey (questionnaire) results. No quality assessment tool was used, but multiple sources were used in order to validate individual, possibly biased, sources. Descriptive analysis was performed on different information sources. The assessment elements questions are answered by cooperation of Domain investigators.

Results FITs or iFOBTs are a class of faecal occult blood tests (tests for blood or blood products). They use blood as an indicator of the presence of tumour. FOBTs are recommended for population-based colorectal carcinoma screening (CRC) screening. The target group is asymptomatic people at average risk, of both genders. Regarding the age-range, there is evidence endorsing the provision of CRC screening to average-risk individuals, beginning at age 50, to detect cancers at a favourable stage before they have advanced to a potentially lethal disease state.

The first FOBTs that were developed were guaiac-based (gFOBTs). FITs use antibodies raised against human haemoglobin (Hb) to detect human blood present in faeces. New technologies in the field of FOBTs include faecal DNA tests, the use of RNA markers in stool as well as the use of DNA or RNA in plasma, serum and urine. Much work is still ongoing on use of protein biomarkers in blood for CRC screening and early detection.

The advantages of FIT in contrast to gFOBT are: specificity for human Hb, reducing the number of false positive results; no dietetic restrictions necessary; increased sensitivity to human Hb; automated analysis and the possibility to set cut-off limits (the latter applies only to quantitative FIT tests). Disadvantages include sample instability in liquid collection devices, therefore shorter transportation time frame is required; possible additional requirements for packaging of the liquid sample collection devices to meet different MSs postal regulation; and cost of the test. These characteristics should be taken into account in the development of CRC screening programmes in different settings.

A wide range of qualitative and quantitative iFOBT tests is presently available, with varying levels of sensitivity and specificity. Similar to gFOBT, participants collect one or more stool samples, which can be analysed either using automated systems in the laboratory (for some manufacturers) or are read by the naked eye with a positive result indicated by a colour change on a strip. Automated systems can be qualitative (providing dichotomous result) or quantitative (user-defined cut-off levels). In HTAs performed in other countries, automated FITs were considered appropriate for assessment for a population-based screening programme; this approach was also adopted in the present Core HTA. Three iFOBT are presented here, as three analytical platforms using the three sample collection devices: OC-Sensor/OC-Sensor Diana & OC-Sensor Micro, Hem-SP/MagStream HT, FOB Gold/SENTiFOB analyser.

In the framework of a CRC programme using FIT as the primary screening method, users of the technology include people invited to participate in the programme as well as the health professionals who are involved (primary care physicians and nurses, laboratory staff). Parameters that should be taken into account when using FIT in CRC programmes are the material investments needed (procurement and maintenance of laboratory analysers, sample collection devices, refrigerated storage spaces, waste disposal systems and, in some cases, end-of-life disposal), and training needs of the laboratory staff. Laboratory staff training depends on the type of test to be used. Qualification, training and quality assurance processes needed relate to those required in a CRC screening with FOBT. Individuals invited to participate in the programme should be provided with specific instructions on how to use the test kit. It is important that the participant is able to understand written instructions on how to perform these procedures (apart from written material, visual communication instruments and/or oral interventions can be used to facilitate understanding). Furthermore, information about CRC screening risks and benefits, CRC risks, meaning of test results, potential diagnostic tests and potential treatment options should be provided to the patients.

As is the case in every CRC screening programme, several kinds of data need to be recorded. Specifically, records should include: data on each individual and every screening test performed, test results, decision made as a consequence, diagnostic and treatment procedures and subsequent outcome (including cause of death).

Important for practice: In different settings, individual device characteristics like ease of use by participant and laboratory, suitability for transport, sampling reproducibility and sample stability are important and should be all taken into account when selecting the iFOBT most appropriate for CRC screening programme.

Introduction

Faecal Immunochemical Tests (FITs), also known as Immunochemical Faecal Occult Blood Test (iFOBTs), are a newer class of Faecal Occult Blood tests (the first FOBTs developed and marketed were gFOBTs). According the EU Guideline for quality assurance in CRC screening and diagnosis (2010), iFOBT have improved test characteristics than gFOBT. iFOBTs have been used for population CRC screening in Japan since 1992. In the US, the first iFOBT (OC-Sensor) has been approved by the FDA (Food and Drug Administration) since 2001. The aim of population-based screening for CRC is to reduce morbidity and mortality from CRC through both, prevention (by the removal of adenomas before they had a chance to become malignant, so CRC incidence is reduced) and earlier diagnosis of CRC (at early, curable stage).

A wide range of qualitative and quantitative FITs is presently available, with varying levels of sensitivity and specificity. They all use antibodies raised against human haemoglobin (Hb) to detect human blood present in faeces.

The older class of faecal occult blood tests, guaiac-based fecal occult blood tests (gFOBTs) has proven characteristics that make them suitable for population CRC screening. The advantages and disadvantages of both, gFOBTs and iFOBTs should be taken into account in the development of CRC screening programmes in different settings, like local labour costs, the mechanism of kit distribution and collection as well as the sample stability characteristics.

The aim of this Domain is to describe and review the technical characteristics of iFOBT.

Methodology

Frame

The collection scope is used in this domain.

TechnologyFecal Immunochemical Test (FIT) for colorectal cancer screening
Description

FITs use an antibody (immunoglobulin) specific to human globin, the protein component of haemoglobin, to detect fecal occult blood. Immunochemical tests have improved test characteristics compared to conventional guaiac-based tests for fecal occult blood. FIT should not be subject to interference from dietary blood and it is more specific to bleeding from the distal gastrointestinal tract. They could be analytically and clinically more sensitive and specific, Their measurement can be automated and the user can adjust the concentration at which a positive result is reported. A wide range of qualitative and quantitative tests is presently available, with varying levels of sensitivity and specificity (like Hem-SP/MagStream H, Fujirebio Inc. Japan ; OC-Sensor, Eiken Chemical Co., Tokyo, Japan;    FOB Gold, Medinostics Products Supplier; Sentinel Diagnostics SpA, Milan, Italy).

Intended use of the technologyScreening

CRC screening with faecal inmunochemical test (FIT) for detection of occult blood in the stool associated with colorectal lesions (adenomas and CRC).

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Early detection and treatment of colorectal lesions before they become symptomatic has the potential to improve control of the disease, reducing morbidity and mortality associated to CRC. Early treatment of invasive lesions can be generally less detrimental for quality of life. The endoscopic removal of pre-malignant lesions also reduces the incidence of CRC by stopping the progression to cancer. Colorectal cancers and adenomatous polyps bleed has providing fecal blood haemoglobin as the biomarker of choice for current screening programmes. Stool samples could be periodically taken and analyzed for the presence of occult blood, as an early sign of colorectal lesions (adenoma or CRC).

Target condition
Adenomas, as non-malignant precursor lesions of ColoRectal Cancer (CRC).
Target condition description

CRC is the third most common in incidence and the fourth most common cause of cancer death worldwide. CRC is particularly suitable for screening. The disease is believed to develop in a vast majority of cases from non-malignant precursor lesions called adenomas. Adenomas can occur anywhere in the colorectum after a series of mutations that cause neoplasia of the epithelium. At some time , the adenoma may invade the submucosa and become malignant. Initially, this malignant cancer is not diagnosed and does not give symptoms  (preclinical phase). It can progress from localised (stage I) to metastasised (stage IV) cancer, until it causes symptoms and is diagnosed. Only 5–6% of the population actually develop CRC. The average duration of the development of an adenoma to CRC is estimated to be  at least 10 years. This long latent phase provides a window of opportunity for early detection of the disease.

Target population

Target population sex: Any. Target population age: adults and elderly. Target population group: Healthy and/or asymptomatic people.

Target population description

Adults, average risk of CRC, aged 50 years or over.

The best age range for offering gFOBT or FIT screening has not been investigated in trials. Circumstantial evidence suggests that mortality reduction from gFOBT is similar in different age ranges between 45 and 80 years .The age range for a national screening programme should at least include people aged 60 to 64 years in which CRC incidence and mortality are high and life-expectancy is still considerable. Only the FOBT for men and women aged 50–74 years has been recommended todate by the EU (Council Recommendation and the European guidelines for quality assurance in CRC screening and diagnosis).

Members of families with hereditary syndromes, previous diagnosis of CRC or pre-malignant lesions should follow specific surveillance protocols and are not included in the target population

ComparisonCRC screening with Guaiac –based fecal occult blood test (gFOBT)
Description

CRC screening with Guaiac–based fecal occult blood test (gFOBT)

The guaiac-based FOBT is still a commonly used method for detecting blood in faeces. To detect hemoglobin the test uses guaiac gum and its efficacy as a colorectal cancer screening test has been analyzed in several randomised controlled trials. The test detects the haem component of haemoglobin, which is identical across human and animal species and is chemically robust and only partially degraded during its passage through the gastrointestinal tract. gFOBTs cannot distinguish between human blood and blood residues from the diet.

Many guaiac-based tests are currently on the market (like Coloscreen, Helena Laboratories,Texas,USA; Hema-screen Immunostics Inc.; Hemoccult, Beckman Coulter Inc.; Hemoccult SENSA, Beckman Coulter Inc.; MonoHaem, Chemicon Europe Ltd; Hema-Check, Siemens PLC; HemaWipe, Medtek Diagnostics LLC)

The use of the test is considered under conditions of population based colorectal cancer screening, in the context of organised cancer screening programmes as recommended by the EU. Population-based programmes have been rolled out nationwide in several European countries. Many member states  haveestablished nationwide non-population-based programmes. Some states are planning or piloting a nationwide population-based programme. These have  adopted only FOBT, some only FIT, some a mix between FOBT and endoscopy, or only colonoscopy.

Outcomes

CUR and TEC

  • Health problems (target condition)
  • Epidemiology
  • Burden of disease
  • Target population
  • Current management of the condition
  • Features of the technology
  • Life-Cycle
  • Regulatory status
  • Utilization
  • Investments and tools required to use the technology
  • Training and information needed to use the technology

SAF

  • Colonoscopy probability of perforation
  • Colonoscopy with polypectomy probability of perforation
  • Colonoscopy probability of death following perforation
  • Probability of bleeding following colonoscopy
  • Psychological harms from false-negatives and false-positives (and generally from participating in screening program)

EFF

  • Test (FIT and gFOBT) sensitivity for adenomas
  • Test (FIT and gFOBT) sensitivity for cancer
  • Test (FIT and gFOBT) specificity for adenomas
  • Test (FIT and gFOBT) specificity for cancer 
  • Adenoma incidence (detection rates)
  • Rectal cancer incidence (detection rates)
  • Colon cancer incidence (detection rates)
  • CRC incidence (detection rates)
  • Stage distribution of detected cancers
  • Rectal cancer specific mortality
  • CRC specific mortality
  • Overall mortality
  • Life years saved

ECO:

  • Model/template for  national pilots  to assess the costs and benefits of the two alternative  technologies FIT and gFOBT  and also no-programmed-screening
  • Systematic literature search of   available models and/or economic  evaluation for screening colorectal cancer with FIT and gFOBT and no screening programme
  • Resource Utilization: Publicly funded health care payer costs (screening tests, further examinations e.g. labor, colonoscopy  and treatments and administration and organisation costs of screening programme) for FIT and gFOBT (in cooperation with ORG)
  • Cost per Case detected (average, marginal, incremental) =  intermediate outcome – optional, not decided yet (relevant for deciding how often a test should be carried out and what are the incremental costs for a “new” detected case
  • Indirect Costs: not for the Core modell (should be decided later on)
  • Test accuracy: from SAF
  • Cost effectiveness analysis: HRQoL measures (both generic and context specific) (EFF and SAF for help, own Lit.research), ICER

 ORG:

  • Responsiveness of target population to invitation
  • Invitation-reminder system
  • Competence of human resources – health professionals
  • Investments needed (material,equipment)
  • Costs of using both tests (FIT, gFOBT)
  • Timeliness of results and future phases
  • Use of tools for process monitoring (completed check lists)
  • Model for Budget Impact Analysis from perspective of the payer

SOC

  • Compliance with the tests (FIT, gFOBT)
  • Anxiety and any psychological effects of using  one test or another
  • Information, counseling, communication (quality of) for the use of tests
  • Satisfaction  
  • Quality of life
  • Equity of access

LEG

  • Information as baseline for an informed consent
  • Harms or inequities that can be taken to court

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
B0001Features of the technologyWhat is this technology?yesWhat is FIT?
B0002Features of the technologyWhy is this technology used?yesWhy is FIT used?
B0003Features of the technologyWhat is the phase of the technology?yesWhat is the phase of FIT?
B0004Features of the technologyWho will apply this technology?yesWho will apply FIT?
B0005Features of the technologyIn what place and context is the technology intended to be used?yesIn what place and context is FIT intended to be used?
B0006Features of the technologyAre there any special features relevant to this technology?yesAre there any special features relevant to FIT?
B0016Features of the technologyTo what population(s) will this technology be used on?yesTo what population(s) will FIT be used on?
B0017Features of the technologyIs this technology field changing rapidly?yesIs FIT field changing rapidly?
B0018Features of the technologyAre the reference values or cut-off points clearly established?yesAre the reference values or cut-off points clearly established?
B0007Investments and tools required to use the technologyWhat material investments are needed to use the technology?yesWhat material investments are needed to use FIT?
B0008Investments and tools required to use the technologyWhat kind of special premises are needed to use the technology?yesWhat kind of special premises are needed to use FIT?
B0009Investments and tools required to use the technologyWhat equipment and supplies are needed to use the technology?yesWhat equipment and supplies are needed to use FIT?
B0010Investments and tools required to use the technologyWhat kind of data and records are needed to monitor the use the technology?yesWhat kind of data and records are needed to monitor the use FIT?
B0011Investments and tools required to use the technologyWhat kind of registers are needed to monitor the use the technology?yesWhat kind of registers are needed to monitor the use FIT?
B0012Training and information needed to use the technologyWhat kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technology?yesWhat kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?
B0013Training and information needed to use the technologyWhat kind of training is needed for the personnel treating or investigating patients using this technology?yesWhat kind of training is needed for the personnel treating or investigating patients using FIT?
B0014Training and information needed to use the technologyWhat kind of training and information should be provided for the patient who uses the technology, or for his family/carer?yesWhat kind of training and information should be provided for the patient who uses FIT, or for his family/carer?
B0015Training and information needed to use the technologyWhat information of the technology should be provided for patients outside the target group and the general public?yesWhat information of FIT should be provided for patients outside the target group and the general public?

Methodology description

Domain frame

The Project scope is applied in this domain.

Information sources

- Basic systematic search. Common (basic) literature search strategy was used, run for the whole project and described in COL Appendix 1;

- Additional search for published literature in PubMed and internet search of grey literature using Google search engine;

- Review of the reference lists and bibliographies of studies identified through the basic systematic search;

- Manufacturers web sites;

- Company brochures and Information for use;

Survey: two questionnaires were administered, to EUnetHTA partners and Manufacturers (more information in COL Appendix 2), with aim to get further information about primary CRC screening methods and tests in different EU countries; please see in COL Appendix 2.

Quality assessment tools or criteria

No quality assessment tool was used, but multiple sources were used in order to validate individual, possibly biased, sources.

Analysis and synthesis

Descriptive analysis was performed on different information sources. The assessment elements questions are answered by cooperation of Domain investigators.

Results cards are covered by evidence gathered from basic search (COL Appendix 1), hand searched literature, manufacturers web sites, company brochures and information for use, and survey (questionnaire) results.

Result cards

Features of the technology

Result card for TEC1: "What is FIT?"

View full card
TEC1: What is FIT?
Result

Importance: Critical

Transferability: Completely

Result card for TEC2: "Why is FIT used?"

View full card
TEC2: Why is FIT used?
Result

Importance: Critical

Transferability: Partially

Result card for TEC3: "What is the phase of FIT?"

View full card
TEC3: What is the phase of FIT?
Result

Importance: Important

Transferability: Completely

Result card for TEC4: "Who will apply FIT?"

View full card
TEC4: Who will apply FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC5: "In what place and context is FIT intended to be used?"

View full card
TEC5: In what place and context is FIT intended to be used?
Result

Importance: Important

Transferability: Partially

Result card for TEC6: "Are there any special features relevant to FIT?"

View full card
TEC6: Are there any special features relevant to FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC16: "To what population(s) will FIT be used on?"

View full card
TEC16: To what population(s) will FIT be used on?
Result

Importance: Critical

Transferability: Partially

Result card for TEC17: "Is FIT field changing rapidly?"

View full card
TEC17: Is FIT field changing rapidly?
Result

Importance: Important

Transferability: Completely

Result card for TEC18: "Are the reference values or cut-off points clearly established?"

View full card
TEC18: Are the reference values or cut-off points clearly established?
Result

Importance: Critical

Transferability: Completely

Investments and tools required to use the technology

Result card for TEC7: "What material investments are needed to use FIT?"

View full card
TEC7: What material investments are needed to use FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC8: "What kind of special premises are needed to use FIT?"

View full card
TEC8: What kind of special premises are needed to use FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC9: "What equipment and supplies are needed to use FIT?"

View full card
TEC9: What equipment and supplies are needed to use FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC10: "What kind of data and records are needed to monitor the use FIT?"

View full card
TEC10: What kind of data and records are needed to monitor the use FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC11: "What kind of registers are needed to monitor the use FIT?"

View full card
TEC11: What kind of registers are needed to monitor the use FIT?
Result

Importance: Important

Transferability: Partially

Training and information needed to use the technology

Result card for TEC12: "What kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?"

View full card
TEC12: What kind of qualification, training and quality assurance processes are needed for the use or maintenance of FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC13: "What kind of training is needed for the personnel treating or investigating patients using FIT?"

View full card
TEC13: What kind of training is needed for the personnel treating or investigating patients using FIT?
Result

Importance: Important

Transferability: Partially

Result card for TEC14: "What kind of training and information should be provided for the patient who uses FIT, or for his family/carer?"

View full card
TEC14: What kind of training and information should be provided for the patient who uses FIT, or for his family/carer?
Result

Importance: Critical

Transferability: Partially

Result card for TEC15: "What information of FIT should be provided for patients outside the target group and the general public?"

View full card
TEC15: What information of FIT should be provided for patients outside the target group and the general public?
Result

Importance: Important

Transferability: Partially

Discussion

Some limitations were observed during assessment of domain questions. Authors recognized importance of appropriate stakeholders’ involvement, but only one Manufacturer responded on our questions. Some assessment element questions are overlapping with assessment element questions in Health problem and current use of the technology (CUR) Domain; some should be placed in different order and some are very similar or almost identical in meaning. Authors suggest that assessment elements questions and results cards CUR 23, 24 and 25 should belong to Technical description and characteristics of the technology (TEC) Domain, as well as CUR 27. Referencing to other results cards is used to minimize duplication. Transferability judgement will be mostly appropriately done by HTA doers at national levels, according the core HTA data presented here.

Important for practice: In different settings, individual device characteristics like ease of use by participant and laboratory, suitability for transport, sampling reproducibility and sample stability are important and should be all taken into account when selecting the iFOBT most appropriate for CRC screening programme.

References

1.         Young GP, St John DJ, Winawer SJ, Rozen P. Choice of fecal occult blood tests for colorectal cancer screening: recommendations based on performance characteristics in population studies: a WHO (World Health Organization) and OMED (World Organization for Digestive Endoscopy) report. The American journal of gastroenterology. 2002;97(10):2499-507. eng.

2.         Rabeneck L, Rumble RB, Thompson F, Mills M, Oleschuk C, Whibley A, et al. Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening. Canadian Journal of Gastroenterology. 2012;26(3):131-47. eng.

3.         Health Information and Quality Authority. Health technology assessment (HTA) of a population-based colorectal cancer screening programme in Ireland. Dublin: Health Information and Quality Authority, 2009.

4.         Rabeneck L RR, Thompson F, Mills M, Oleschuk C, Whibley AH, et al. Fecal immunochemical tests compared with guaiac fecal occult blood tests for population-based colorectal cancer screening. Toronto, ON: Cancer Care Ontario, 2011 Nov 8  Contract No.: Program in Evidence-based Care Evidence-based Series No.: 15-8.

5.         NHS Centre for Evidence-based Purchasing. Evaluation report: Immunohistocemical faecal occult blood tests. NHS Purchasing and Supply Agency, 2009 CEP09042.

6.         Segnan N, Patnick J, von Karsa L, editors. European guidelines for quality assurance in colorectal cancer screening and diagnosis - First Edition. 1st ed. Luxembourg: Publications Office of the European Union; 2010.

7.         Whyte S, Chilcott J, Cooper K, Essat M, Stevens J, Wong R, et al. Re-appraisal of the options for colorectal cancer screening. Report for the NHS Bowel Cancer Screening Programme. Sheffield: University of Sheffield, School of Health and related Research, 2011.

8.         Guittet L, Guillaume E, Levillain R, Beley P, Tichet J, Lantieri O, et al. Analytical comparison of three quantitative immunochemical fecal occult blood tests for colorectal cancer screening. Cancer Epidemiol Biomarkers Prev. 2011 2011 Jul;20(7):1492-501. eng.

9.         von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, et al. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. eng.

10.       van Rossum LGM, van Rijn AF, van Oijen MGH, Fockens P, Laheij RJF, Verbeek ALM, et al. False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening. International Journal of Cancer. 2009;125(4):746-50.

11.       Young GP. Fecal immunochemical tests (FIT) vs. office-based guaiac fecal occult blood test (FOBT). Pract Gastroenterol. 2004 2004;28(6):46-56.

12.       Lin J, Webber E, Beil T, Goddard K, EP W. Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults. Rockville, MD: Agency for Healthcare Research and Quality, 2012  Contract No.: AHRQ Publication 12-EHC022-EF.

13.       Exact Sciences Corp. Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer. [Internet]. 2013, April 18 [cited 2013 Aug 9]. Available from: http://investor.exactsciences.com/releasedetail.cfm?ReleaseID=757341.

14.       ClinicalTrials.gov. Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C) [Internet]. U.S. National Institutes of Health; 2013, Jun 18 [cited 2013 Aug 9]. Available from: http://prsinfo.clinicaltrial.gov/ct2/show/record/NCT01397747?id=NCT01397747&rank=1).

15.       Council of the European Union. Recommendation of 2 December 2003 on cancer screening. 2003/878/EC. Off J Eur Union. 2003:34–8.

16.       Medical Advisory Secretariat. Screening Methods for Early Detection of Colorectal Cancers and Polyps. Summary of Evidence-Based Analyses. Toronto: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care, 2009  Contract No.: 6.

17.       Epigenomics AG. Epigenomics AG submits the fourth module and completes its PMA submission to the FDA for Epi proColon®. [Internet]. Epigenomics AG,; 2013, Jan 7 [cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

18.       ClinicalTrials.gov. Head to Head Study Epi proColon and FIT. [Internet]. U.S. National Institutes of Health; 2013 [updated 2013, Feb 6; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

19.       Epigenomics AG. Results of Comparative Study between Epigenomics Epi proColon® and FIT to be Presented at Digestive Disease Week. [Internet]. Epigenomics AG,; 2013, Mar 15 [updated 2011; cited 2013 Oct 26]. Available from: http://clinicaltrials.gov/ct2/show/record/NCT01580540.

20.       van Rossum LGM, van Rijn AF, Laheij RJF, van Oijen MGH, Fockens P, Jansen JBMJ, et al. Cutoff value determines the performance of a semi-quantitative immunochemical faecal occult blood test in a colorectal cancer screening programme. British journal of cancer. 2009;101(8):1274-81.

 

 

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