Result card

  • TEC17: Is FIT field changing rapidly?
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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}.

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 16 June 2021]. Available from: