Result card

  • CUR23: In which phase is the development of FIT?

In which phase is the development of FIT?

Authors: Mirjana Huic, Eleftheria Karampli, Silvia Florescu, Cipriana Mihaescu-Pintia

Internal reviewers: Laura Cacciani, Sophie Brunner, Esther Kraft

Same as Result card TEC 3 in the Domain Technical description and characteristics of the technology.

FITs (Faecal immunochemical tests), 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 2010 (2), iFOBT 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 FDA (Food and Drug Administration) since 2001 (OC-Sensor).

Today, a wide range of qualitative and quantitative tests is available worldwide. Overtime, 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  {77}.

New generation DNA tests for CRC screening will combine genetic markers with an immunochemical assay for haemoglobin {62}. A multi-marker fecal 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 {78} registered in (NCT01397747) {79}. No study results posted on yet.  This study compared the performance of the Cologuard test to colonoscopy and fecal immunochemical testing or FIT (according the, 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.

Huic M et al. Result Card CUR23 In: Huic M et al. Health Problem and Current Use of the 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: