These new tests aren't radical departures from the standard FIT. Like the standard test, the multitarget FIT uses antibodies to test for hemoglobin in stool samples . But these multitarget approaches take the standard FIT a step further by testing for additional DNA , RNA , or protein biomarkers associated with CRC to help improve early detection .— as well as a third noninvasive CRC screening test, guaiac fecal occult blood test .
Three new noninvasive multitarget tests under investigation — an updated DNA-based test, Cologuard 2.0 ; an RNA-based test, ColoSense ; and a protein-based test from CRCbioscreen — may be able to do just that. An updated version of the stool FIT-DNA is currently under development. Dubbed Next Generation Cologuard, or Cologuard 2.0, this multitarget test detects three novel methylated DNA markers along with fecal hemoglobin.comparing Cologuard 2.
Compared with the original Cologuard, Cologuard 2.0's sensitivity improved slightly for CRC, from 92% to 93.9%,; for advanced precancerous lesions, from 42% to 43.4%; and for high-grade dysplasia, from 69% to 75%. Specificity also improved with the latest version, ColoSense showed higher sensitivity than standard FIT for the presence of CRC and advanced adenomas . In the group aged 45-50 years, the RNA-based test had a sensitivity of 100% for CRC, correctly identifying all five people with colonoscopy-confirmed CRC, and 45% for advanced adenomas.
Overall, the analysis included stool samples from 13,187 patients aged 55-75 years who were in the Netherlands' national CRC screening program. Stool samples were evaluated with both the multitarget test and the standard FIT, using a positivity cutoff ≥ 47 µg hemoglobin/g feces. Colonoscopy data were available for only 1270 participants.
Perhaps the most telling comparison occurred in scenario 2, with both tests set at the same low positivity threshold to minimize false-positives.
Source: Healthcare Press (healthcarepress.net)
Multitarget FIT Test Early Detection Colorectal Cancer Antibodies Stool Samples DNA RNA Protein Biomarkers False-Positive Findings
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