Result card

  • TEC17: Is FIT field changing rapidly?
Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening
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Is FIT field changing rapidly?

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

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

This field of faecal tests for CRC screening is changing fast according literature data. In addition to faecal DNA tests, new area of research is 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.

For phase of FIT please see Result card TEC 3.

Faecal DNA tests represent new group of faecal tests designed to detect molecular abnormalities in cancer or precancerous lesion that are shed into the stool. Two faecal DNA tests were commercially available: PreGen Plus, from 2003 to 2008, and ColoSure (single marker faecal DNA assay for methylated vimentin) the only commercially available test in the US, intended for individuals who are not eligible for more invasive CRC screening. New test showed evolution in the composition of the test, as well in pre-analytical factors and analytic factors in comparison with older faecal DNA tests. Authors of the 2012 AHRQ HTA Report {12} concluded that faecal DNA tests have insufficient evidence about its diagnostic accuracy to screen for colorectal cancer in asymptomatic, average-risk patients; insufficient evidence for the harms, analytic validity, and acceptability of testing in comparison to other screening modalities. Existing evidence has little or no applicability to currently available faecal DNA testing.

At its website, Epigenomics stated that Septin9 test, the world's first blood-based IVD test for CRC screening, has been available as a CE-marked test kit in Europe and the Middle East since October 2009. For the improved Septin9 test, Epi proColon 2.0, according to the company’s press release {17}, the fourth module of the PMA was submitted to FDA, which contained the clinical data generated with the test, including the results of the recently reported head-to-head comparative study of the performance of the Epi proColon® to FIT(18) (with no study results posed yet), previously announced data from a clinical validation study in a cohort of prospectively collected samples and other clinical study results generated during the development of Epi proColon®. On 15 05 2013 they also announced that results of the head-to-head comparative study between its blood-based CRC detection test Epi proColon and FIT will be presented at the workshop of the WEO CRC Screening Committee during conference in Orlando, May 17, 2013 {19}.

Important
Completely
Huic M et al. Result Card TEC17 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 28 June 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.