핵심 개념
Next-generation mt-sDNA test shows higher sensitivity but lower specificity compared to FIT for CRC screening.
초록
The next-generation multitarget stool DNA (mt-sDNA) test for colorectal cancer (CRC) screening demonstrated higher sensitivity for all screening-relevant lesions but lower specificity than the currently available fecal immunochemical test (FIT). The study aimed to improve specificity without compromising sensitivity, addressing the need for more accurate and noninvasive screening methods to enhance adherence to CRC screening guidelines.
Key Highlights:
- Next-generation mt-sDNA test by Exact Sciences Corporation showed almost 94% sensitivity for CRC.
- Sensitivity for advanced precancerous lesions was over 43%, with nearly 91% specificity for advanced neoplasia.
- The new test aimed to address feedback on low specificity while maintaining high sensitivity for CRC.
- Improved specificity by 30% for advanced neoplasia compared to the previous version of Cologuard.
- Higher specificity expected to reduce false positive rates and unnecessary colonoscopies.
Testing Details:
- Study evaluated almost 21,000 asymptomatic participants aged 40 and older undergoing screening colonoscopy.
- The new DNA test identified 92 out of 98 participants with CRC and 76 out of 82 participants with screening-relevant cancers.
- Comparison with OC-AUTO FIT by Polymedco showed varying sensitivity and specificity rates for different lesions.
Future Implications:
- Further research needed to determine the test's acceptability, adherence rates, and cost-effectiveness.
- Importance of reducing the incidence and mortality of colorectal cancer through effective screening methods.
- Considerations for cost-effectiveness, testing intervals, and population-based screening strategies.
통계
The multitarget assay showed a sensitivity for CRC of almost 94%.
Specificity for advanced neoplasia was nearly 91%.
The comparator FIT had a specificity of 94.8% for advanced neoplasia.
인용구
"The test's manufacturer developed a new version of its existing Cologuard FIT/DNA test because it took to heart the feedback from primary care providers and gastroenterologists about the test's low specificity."
"Many physicians felt there were too many false positives with the existing version, and that is anxiety-provoking in patients and providers."
"It is hoped that these newer tests will increase use and adherence and elevate the percentage of the population undergoing screening in order to reduce deaths from colorectal cancer."