Next-Generation Stool DNA Test Shows Highest Detection Rate Among Noninvasive Colorectal Cancer Screening Tools

Next-Generation Stool DNA Test Shows Highest Detection Rate Among Noninvasive Colorectal Cancer Screening Tools


A recent study led by Regenstrief Institute and Indiana University School of Medicine research scientist Dr. Thomas Imperiale has revealed that the next-generation multi-target stool DNA colorectal cancer screening test is capable of detecting 94% of colorectal cancers. The study, which involved over 21,000 average-risk patients from 186 sites across the U.S., demonstrated that this innovative test outperforms other noninvasive screening tools in detecting both colorectal cancer and advanced precancerous polyps. The findings of this study have been published in the prestigious New England Journal of Medicine.

Dr. Imperiale, the first author of the study, emphasized the superior sensitivity of the next-generation stool DNA test compared to the fecal immunochemical test (FIT). He explained that the new test struck a good balance between sensitivity (detecting disease) and specificity (low false positive results). While a direct comparison between the current and next-generation tests was not made, the study results indicated that the new version exhibited either similar or slightly improved sensitivity and approximately 30% better specificity, leading to significantly fewer false positives.

The study participants, asymptomatic males and females aged 40 years or older, represented a diverse population that mirrors the racial and ethnic demographics of individuals eligible for colorectal cancer screening in the U.S. The next-generation multi-target stool DNA test, which incorporates new biomarkers, demonstrated superior performance in detecting cancers and advanced precancerous lesions compared to the commonly used FIT test. However, the FIT test had a lower overall false positive rate. Notably, both tests require a single stool sample and differ in their frequency of administration – FIT annually and stool DNA testing at three-year intervals.

Dr. Imperiale highlighted the pivotal role of primary care providers in driving colon cancer screening efforts. While the study showcased the higher sensitivity of the next-generation DNA stool test over FIT, it does not definitively declare one screening modality as superior. The choice of screening method should be determined through a collaborative discussion between the clinician and the patient, considering various factors such as disease risk and patient compliance.

Ideal candidates for the next-generation stool DNA test are average-risk individuals aged 45 to 60-to-65 years without predisposing factors for colorectal cancer. These factors include a personal history of inflammatory bowel disease, previous colorectal cancer or pre-cancerous polyps, and a significant family history of early-onset colorectal cancer. Colorectal cancer, the second leading cause of cancer-related deaths in the U.S., affects approximately 153,000 individuals annually. Screening for colorectal cancer is recommended by the U.S. Preventive Services Task Force and the American Cancer Society for average-risk men and women aged 45 to 75. Despite the proven benefits of screening in reducing colorectal cancer incidence and mortality, adherence rates remain below 60% as of 2021.

1. Source: Coherent Market Insights, Public sources, Desk research
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