Result card

  • TEC3: What is the phase of FIT?
Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening
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What is the phase of FIT?

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

Internal reviewers: Antonio Migliore, Pernilla Östlund, Frida Mowafi, Daniela d’Angela, Jesus Gonzalez

FITs are a newer class of Faecal Occult Blood tests (the first FOBTs developed and marketed were gFOBTs). According the EU Guideline 2010(6), iFOBTs have improved test characteristics than gFOBT. iFOBTs have been used for population CRC screening in Japan since 1992. In the US, iFOBTs have been approved by the FDA (Food and Drug Administration) since 2001 (OC-Sensor).

Today, a wide range of qualitative and quantitative tests is available worldwide. Over time, manufacturers have developed new sampling methods (brush-sampling vs stick-sampling FIT) with the aim of increasing simplicity of use and acceptability of test by participants {11}.

According to Lin et al. {12}, a new generation DNA test for colorectal cancer screening will combine genetic markers with an immunochemical assay for haemoglobin. A multi-marker faecal DNA test plus FIT, Cologuard has been developed by Exact Sciences Corp.  They announced results of preliminary analysis of recently completed DeeP-C pivotal clinical trial in April 2013 (13), registered in ClinicalTrial.gov {14}. No study results posted on ClinicalTrials.gov yet. This study compared “the performance of the Cologuard test to colonoscopy and faecal immunochemical testing or FIT” (according the ClinicalTrial.gov, Primary outcome was Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer; Secondary outcome was to compare the performance of the Exact CRC screening test to a commercially available FIT, both with respect to cancer and advanced adenoma). Exact Sciences planned to submit data from the DeeP-C study to the U.S. Food and Drug Administration as part of its pre-market approval (PMA) submission, and will submit the study's complete data set for publication in a peer-reviewed journal, presentation at a major medical meeting or both.

Important
Completely
Huic M et al. Result Card TEC3 In: Huic M et al. Description and technical characteristics of technology In: 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 17 August 2022]. Available from: http://corehta.info/ViewCover.aspx?id=206

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.