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The fecal immunochemical test (FIT) is the most widely used test for colorectal cancer (CRC) screening. RAID-CRC Screen is a new non-invasive test based on fecal bacterial markers, developed to complement FIT by increasing its specificity. The test was previously clinically evaluated in FIT-positive patients (>20 μg of hemoglobin/g of feces, “FIT20”), in which it reduced the proportion of false positive results by 16.3% while maintaining most of FIT20’s sensitivity. The aim of this study was to compare the sensitivity and specificity of a CRC screening program using RAID-CRC Screen in addition to FIT20 as a triage test in a European screening population undergoing screening colonoscopy with a CRC screening program with FIT20 alone in the same cohort. A cohort of 2481 subjects aged > 55 years from the German screening colonoscopy program was included. The colonoscopy findings were used as the gold standard in calculating the diagnostic capacity of the tests and included 15 CRC and 257 advanced neoplasia cases. RAID-CRC Screen added to FIT20 provided the same sensitivity as FIT20 alone (66.7%) in detecting CRC and a significantly higher specificity (97.0% vs. 96.1%, p<0.0001). The positive predictive value was 11.9% when using RAID-CRC Screen and 9.5% with FIT20 alone, and the negative predictive value was 99.8% in the two scenarios. For advanced neoplasia detection, the use of RAID-CRC Screen yielded significantly lower sensitivity than with FIT20 alone (17.5% vs. 21.8%, p = 0.0009), and the overall specificity was significantly higher when using RAID-CRC Screen compared with FIT20 alone (98.2% vs. 97.8%, p = 0.0039). Our findings confirm the results obtained in previous clinical studies in a CRC screening setting, showing the potential of RAID-CRC Screen to increase the overall specificity of FIT-based screening.

Guidelines recommend routine screening for colorectal cancer (CRC) in asymptomatic adults starting at age 50. The most extensively used noninvasive test for CRC screening is the fecal immunochemical test (FIT), which has an overall sensitivity for CRC of approximately 61.0%-91.0%, which drops to 27.0%-67.0% for advanced adenomas. These figures contain a high false-positive rate and a low positive predictive value. This work aimed to develop a new, noninvasive CRC screening tool based on fecal bacterial markers capable of decreasing FIT false-positive rates in a FIT-positive population. We defined a fecal bacterial signature ( RAID-CRC Screen ) in a proof-of-concept with 172 FIT-positive individuals and validated the obtained results on an external cohort of 327 FIT-positive subjects. All study participants had joined the national CRC screening program. In the clinical validation of RAID-CRC Screen , a sensitivity of 83.9% and a specificity of 16.3% were obtained for the detection of advanced neoplasm lesions (advanced adenomas and/or CRC). FIT 20 μg/g produced 184 false-positive results. Using RAID-CRC Screen , this value was reduced to 154, thus reducing the false-positive rate by 16.3%. The RAID-CRC Screen test could be implemented in CRC screening programs to allow a significant reduction in the number of colonoscopies performed unnecessarily for FIT-positive participants of CRC screening programs.

[This corrects the article DOI: 10.1371/journal.pone.0243158.].

Abstract Background and Aims Crohn’s disease and ulcerative colitis evolve with alternate outbreaks and remissions of variable duration in both cases. Despite the advances, about 10-30% of patients do not respond to the treatment after the induction period. Besides, between 20% to 50% further patients need an optimization of the dose to respond the treatment. Recent studies have pointed gut microbiota can play a role in the anti-TNF treatment response. This study aimed to define a bacterial signature that could be used to predict the response of patients to anti-TNF treatment. Methods There were obtained 38 stool samples from 38 IBD patients before starting anti-TNF treatments: Adalimumab, Golimumab or Infliximab. Patients were differentiated in 2 groups: responders and non-responders to biological treatment. From each sample, DNA was purified and used in a qPCR for the quantification of the 8 microbial markers. Results In this proof of concept, the predictive ability to identify anti-TNF treatment responders was analyzed. An algorithm consisting in the combination of 4 bacterial markers showed a high capacity to discriminate between responders and non- responders. The algorithm proved high sensitivity and specificity reporting values of 93.33% and 100% respectively, with a positive predictive value of 100% and a negative predictive value of 75% for predicting response to biologic treatment. Conclusions A specific bacterial signature could beneficiate patients with inflammatory bowel disease predicting the therapeutic effectiveness of an anti-TNF treatment, leading to a personalized therapy, improving the patients’ quality of life, saving costs and gaining time in patient improvement. Lay Summary This study aimed to define a microbial signature that could be used to predict the response of patients to anti-TNF treatment in inflammatory bowel disease. An algorithm consisting in the combination of 4 bacterial markers showed a high capacity to discriminate between responders and nonresponders.

BackgroundMany studies have shown the importance of the relationship between intestinal microbiota and health in recent years. This has led to the development of different microbiota tests, but still, there is a need to provide tests that determine dysbiosis. In this line, it was developed a microbial panel to summarize the gut microbiota state and identify dysbiosis, consisting of 15 key microbial markers representing the human intestinal microbiota.This work aimed to clinically validate the robustness of the microbial markers panel by comparing its outcomes with clinical parameters and the dysbiosis index use.MethodsThere were recruited 154 subjects undergoing the microbiota panel analysis. Clinical data and diagnosis of the enrolled subjects were recorded. Total DNA was extracted, and the abundance of the microbial markers was analysed by qPCR. Statistical analysis was performed using RStudio.ResultsA MANOVA analysis determined no significant differences between genders when the microbial abundance that composes the panel is analysed. In addition, no significant differences were observed according to the patient‘s age classification. The microbial panel showed significant differences (p-value 0.017) according to the type of stool (diarrhoea, constipation, or mixed), observing an inverse behaviour in A.muciniphila and M.smithii. The dysbiosis index was divided into healthy, temporary, and dysbiotic. Significant differences were observed when comparing the abundance of the markers to the dysbiosis index (p-value <0.001), showing how when the dysbiosis index is healthy; there is minimal variation in the microbial markers panel; when it is temporary, the variation increases, and when it is dysbiotic, the general dysbiosis is evident.ConclusionsThe clinical validation of the panel of microbial markers demonstrated to be a good indicator of the general state of the intestinal microbiota and to overcome 2 factors: gender and age, and to differentiate 2 dysbiosis degrees.This test could be a potential first step towards the quantification of the intestinal microbiota not only with application to digestive diseases but for all conditions that have already been shown to have dysbiosis.

BackgroundThe faecal immunochemical test (FIT) is the most widely used test for colorectal cancer (CRC) screening. RAIDCRCScreen is a non-invasive test based on faecal biomarkers that complement FIT by increasing its specificity. It was previously clinically evaluated in FIT-positive patients (>20µg haemoglobin/g faeces, ‘FIT20’), in which it reduced the proportion of false-positive (FP) results by 16.3% for CRC and for advanced neoplasia (AN) while maintaining FIT20’s sensitivity for CRC detection.The aim was to demonstrate superiority in specificity and non-inferiority in sensitivity of the RAIDCRCScreen versus FIT20 in a screening cohort undergoing colonoscopy.MethodsA cohort of 2481 subjects aged >55 years from the German CRC screening program was retrospectively included in the DKFZ. They collected a faecal sample prior to colonoscopy to analyse the FIT and the RAID-CRC-Screen test.ResultsRAIDCRCScreen maintained the sensitivity of FIT20 (66.7%) for CRC detection while showing a significantly higher specificity (97.0% vs. 96.1%, p<0.0001). The positive predictive value was higher for RAIDCRCScreen (11.9%) compared with FIT20 alone (9.5%), and the negative predictive value was 99.8% for the two tests. The sensitivity of RAIDCRCScreen in detecting AN was significantly lower compared with FIT20 alone (19.9% vs. 24.8%, p<0.001), whereas the specificity was significantly higher (98.3%) compared with FIT20 alone (97.8%) (p<0.005).In terms of added value over FIT, RAIDCRCScreen reduced the proportion of FIT20 FP by 22.1% while maintaining 100% the proportion of true positives identified by FIT20. For the detection of AN, RAIDCRCScreen decreased the FP rate by 20.4%. The proportion of FIT20 true positives that RAIDCRCScreen still identified was reduced to 80.4%. These results are in line with those obtained in previous studies for both CRC and AN endpoint.ConclusionsOur results elucidate the potential of RAIDCRCScreen to improve the precision of the current CRC screening avoiding unnecessary colonoscopies. The introduction in clinical practice of a three-step CRC screening strategy in which RAIDCRCScreen is performed in FIT-positive individuals can help to rationalize the allocation of resources and alleviate the assistential and economic burden of the healthcare system.