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  • TEC3: What is the phase of FIT?
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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.

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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 16 June 2021]. Available from: http://corehta.info/ViewCover.aspx?id=206

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