scholarly journals Evaluating the clinical performance of a dual-target stool DNA test for colorectal cancer detection

Author(s):  
Zhongxin Wang ◽  
Jian Shang ◽  
Guannan Zhang ◽  
Lingjun Kong ◽  
Feng Zhang ◽  
...  
2017 ◽  
Vol 85 (3) ◽  
pp. 657-665.e1 ◽  
Author(s):  
David H. Johnson ◽  
John B. Kisiel ◽  
Kelli N. Burger ◽  
Douglas W. Mahoney ◽  
Mary E. Devens ◽  
...  

2021 ◽  
Author(s):  
Zhongxin Wang ◽  
Jian Shang ◽  
Guannan Zhang ◽  
Lingjun Kong ◽  
Feng Zhang ◽  
...  

BACKGROUND AND AIMS: Methylation-based stool DNA test showed a promising application for colorectal cancer (CRC) detection. This study aimed to evaluate the performance of a novel dual-target stool DNA test (DT-sDNA), composed of SDC2 and TFPI2, for the detection of CRC in clinical practice by using large-scale data from a multicenter clinical trial. METHODS: We enrolled 1,164 participants from three independent hospitals, including 320 CRC patients, 148 adenomas, 396 interfering diseases and 300 healthy controls. Their stool samples were collected and tested paralleled by DT-sDNA test under the guidance of standard operating procedure. All participants were dichotomized as positive and negative according to the cycling threshold (Ct) values measured by quantitative methylation-specific PCR (MSP). The diagnostic performance of DT-sDNA test was assessed by calculating indexes of sensitivity, specificity, and overall coincidence rate. Sanger sequencing and retesting of resected participants were performed to verify the accuracy and effectiveness of the test. RESULTS: Overall, the sensitivity, specificity, and total coincidence rate of DT-sDNA test for CRC detection were 95.31%, 88.39%, and 90.29%, respectively, with the kappa value of 0.775 (P < 0.05) when comparing to non-CRCs. The sensitivities for the detection of advanced adenomas (n=38) and non-advanced adenomas (n=110) were 63.16% and 33.64%, and the specificity was 96.67% for healthy normal controls. The methylation status of SDC2 and TFPI2 in 375 samples were verified by Sanger sequencing and the average coincidence rate reached 99.62%. The coincidence rate was 94.12% (n=32) for 34 participants that undertook DT-sDNA test again after surgical resection. These results demonstrated high accuracy of the DT-sDNA test in discriminating CRCs from other diseases and healthy controls. CONCLUSIONS: The novel DT-sDNA test showed good performance for the diagnosis of colorectal cancer in clinical practice.


2008 ◽  
Vol 103 (11) ◽  
pp. 2862-2870 ◽  
Author(s):  
Steven Itzkowitz ◽  
Randall Brand ◽  
Lina Jandorf ◽  
Kris Durkee ◽  
John Millholland ◽  
...  

Author(s):  
Lesley-Ann Miller-Wilson ◽  
Lila J Finney Rutten ◽  
Jack Van Thomme ◽  
A Burak Ozbay ◽  
Paul J Limburg

Abstract Purpose Colorectal cancer (CRC) is the second most deadly cancer in the USA. Early detection can improve CRC outcomes, but recent national screening rates (62%) remain below the 80% goal set by the National Colorectal Cancer Roundtable. Multiple options are endorsed for average-risk CRC screening, including the multi-target stool DNA (mt-sDNA) test. We evaluated cross-sectional mt-sDNA test completion in a population of commercially and Medicare-insured patients. Methods Participants included individuals ages 50 years and older with commercial insurance or Medicare, with a valid mt-sDNA test shipped by Exact Sciences Laboratories LLC between January 1, 2018, and December 31, 2018 (n = 1,420,460). In 2020, we analyzed cross-sectional adherence, as the percent of successfully completed tests within 365 days of shipment date. Results Overall cross-sectional adherence was 66.8%. Adherence was 72.1% in participants with Traditional Medicare, 69.1% in participants with Medicare Advantage, and 61.9% in participants with commercial insurance. Adherence increased with age: 60.8% for ages 50–64, 71.3% for ages 65–75, and 74.7% for ages 76 + years. Participants with mt-sDNA tests ordered by gastroenterologists had a higher adherence rate (78.3%) than those with orders by primary care clinicians (67.2%). Geographically, adherence rates were highest among highly rural patients (70.8%) and ordering providers in the Pacific region (71.4%). Conclusions Data from this large, national sample of insured patients demonstrate high cross-sectional adherence with the mt-sDNA test, supporting its role as an accepted, noninvasive option for average-risk CRC screening. Attributes of mt-sDNA screening, including home-based convenience and accompanying navigation support, likely contributed to high completion rates.


2019 ◽  
Vol 114 (1) ◽  
pp. S1565-S1565
Author(s):  
MIchael Domanico ◽  
Sandra Statz ◽  
Emily Weiser ◽  
Rebecca Swartz ◽  
Barry M. Berger ◽  
...  

2012 ◽  
Vol 142 (2) ◽  
pp. 248-256 ◽  
Author(s):  
David A. Ahlquist ◽  
Hongzhi Zou ◽  
Michael Domanico ◽  
Douglas W. Mahoney ◽  
Tracy C. Yab ◽  
...  

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