On July 26, 2021 CRCbioscreen, a Dutch diagnostics company, reported to developing a next generation stool test for population based ColoRectal Cancer or CRC screening, reported the publication of promising results of a diagnostic accuracy study with a multitarget immunochemical test (mtFIT) for early detection of CRC (Press release, CRC bioscreen, JUL 26, 2021, View Source [SID1234585204]). Data were published in the prestigious journal Annals of Internal Medicine. The researchers found that the combination of 3 biomarkers (hemoglobin, calprotectin and serpin F2) had significantly higher sensitivity compared with the standard FIT test, without compromising specificity. The mtFIT detects 35% more advanced adenomas, which could translate into 12% CRC incidence reduction and 8% CRC mortality reduction.
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The paper was authored by a team of researchers and clinicians from the Netherlands Cancer Institute, Amsterdam, in collaboration with researchers from AmsterdamUMC and ErasmusMC in Rotterdam, The Netherlands.
Addition of protein biomarkers
The researchers used bio-banked residual FIT sample buffer from 1,284 patients to assess if the addition of protein biomarker quantification in stool could be used to improve the sensitivity of FIT, without sacrificing specificity. The patients were classified by their most advanced lesion – CRC, advanced adenomas, advanced serrated polyps, nonadvanced adenomas, and nonadvanced serrated polyps—and then classification and regression tree (CART) analysis was applied to biomarker concentrations in order to identify the optimal combination for detecting advanced neoplasia. Performance of this combination, the mtFIT, was cross-validated using a ‘leave-one-out’ approach and compared with FIT at equal specificity.
Sensitivity increased by 35% for advanced adenomas
The researchers found that the combination of 3 biomarkers (hemoglobin, calprotectin and serpin F2) had significantly higher sensitivity than FIT for advanced neoplasia (i.e. CRC and advanced precursor lesions) with equal specificity to FIT. The improvement was seen in the advanced adenomas, for which sensitivity was increased by 35%, while sensitivity for CRC and advanced serrated polyps did not change. The improved sensitivity for advanced adenomas may prove critical to improving FIT’s performance as a cancer prevention test. The authors estimate that when performed biennially and compared to traditional biennial FIT, mtFIT would reduce CRC incidence and mortality by 12% and 8%, respectively, assuming 73% adherence.
Finally, the mtFIT was also deemed cost-effective. Funding has been secured to conduct a prospective screening trial to further validate mtFIT within the context of the Dutch CRC screening program.
An independent editorial comment in the same issue of the journal commented on the study to be "important because the challenge of building a better screening test was approached from the perspective of an organized, population-based screening program, and it shows the potential of relatively inexpensive enhancements to the widely used FIT to improve sensitivity without sacrificing specificity" and "Ultimately, this study offers promise of incremental but important improvements in the effectiveness of population-based CRC screening through novel biomarker measurement using an existing screening platform."
Prof. Dr. Gerrit Meijer, CRCbioscreen’s CSO and principal investigator, commented:
"We are very pleased with the results of this diagnostic accuracy study. There is a need for a noninvasive screening test that has higher sensitivity for precursor lesions without increasing false-positive test results. This multitarget protein-based test shows a substantial improvement over FIT in detecting advanced adenomas, while the test logistics still remain fully compatible with that of current FIT based population screening programs. Early detection of colorectal cancer can save many lives. These data underscore our commitment to contribute to a substantial worldwide reduction in incidence and deaths due to this life-threatening disease."
Dr. Meike de Wit, CRCbioscreen’s COO and corresponding author, adds:
"These findings provide a solid basis for conducting a prospective screening trial in the context of the Dutch national CRC screening program. In that study, which is co-funded by CRCbioscreen and is planned to be launched this autumn, the multitarget FIT will be compared to FIT in 13,000 participants of the Dutch national colorectal cancer screening program."