Despite higher sensitivity, multitarget stool DNA tests not as cost-effective for early detection of CRC compared with FIT

Embargoed for release until 5:00 p.m. ET on Monday 12 May 2025   

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.   
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1. Despite higher sensitivity, multitarget stool DNA tests not as cost-effective for early detection of CRC compared with FIT  

FIT would still be more cost-effective even if Cologuard and Cologuard Plus test costs were lowered to $100

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-04026

URL goes live when the embargo lifts              

A brief research report compared screening costs per early-detected colorectal cancer (CRC) case among fecal immunochemical tests (FIT), multitarget stool DNA tests (MSDT) and next-generation MSDTs (N-G MSDT). The study found that screening costs per early-detected advanced neoplasia and CRC case are higher for MSDT-based and N-G MSDT–based screening than for FIT-based screening. The costs per additional early-detected detected CRC case would still be significantly higher than FIT-based screening even if MSDT and N-G MSDT test costs were lowered to less than 20% of their current costs. The study is published in Annals of Internal Medicine. 

Researchers from the German Cancer Research Center in Heidelberg, Germany analyzed results of two studies comparing the diagnostic performance of the MSDT (Exact Sciences’ Cologuard) and N-G MSDT (Exact Sciences’ Cologuard Plus) and a commercial FIT, costs per test reimbursed by Medicare, and uptake rates of colonoscopy after a positive result. The researchers summed the test and follow-up colonoscopy costs and divided the costs by number of study participants with detected CRC or any advanced neoplasia. They also calculated costs per additional early-detected CRC case or any advanced neoplasia. The researchers found that, assuming 60% uptake of follow-up colonoscopy, screening costs per detected advanced neoplasia case or early detected CRC case are 7- to 9-fold higher for MSDT-based and N-G MSDT-based screening than for FIT-based screening. Costs per additional early-detected CRC case compared with FIT-based screening are approximately 40 and 30 times higher, respectively, than costs for the FIT detected CRC cases. The researchers also conducted an analysis assuming lower (30%) and higher (90%) follow-up colonoscopy uptake and hypothetical lower costs per test for MSDT and N-G MSDT. With the lower uptake rate of screening, the incremental costs for early detection of one additional CRC case compared with FIT-based screening would increase to more than $1.4 million for the MSDT and more than $1.5 million for the N-G MSDT. With the higher uptake rate, the detection rates per CRC case would be somewhat lower, but the incremental costs for early detection of one additional CRC case would still be above $500,000 for both the MSDT and N-G MSDT. The researchers note that although the MSDT and N-G MSDT have higher sensitivity compared to FIT, the same sensitivity and specificity could be achieved at no incremental cost by lowering the FIT positivity threshold. 

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To contact corresponding author Hermann Brenner, MD, MPH, please email Sibylle Kohlstädt at s.kohlstaedt@dkfz.de.

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2. As demand for “nonvaccinated” blood increases, experts call for national policy prohibiting directed blood donations

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-25-00815 

URL goes live when the embargo lifts    

According to data from the 2021 U.S. National Blood Collection & Utilization Survey, transfusions from directed donors, or those chosen specifically by the recipient, have increased by 11.1% as compared with 2019. Requests are primarily being driven by recipients’ desire to avoid exposure to blood from COVID-19–vaccinated donors. Now, some states, such as Iowa, Kentucky, and Wyoming, have sought to mandate requests for directed donation, including those demanding “nonvaccinated” blood. The authors of a commentary published in Annals of Internal Medicine say a national policy prohibiting such practices is warranted. 

Lead authors from the University of Minnesota, the Association for the Advancement of Blood and Biotherapies (AABB), Vanderbilt University Medical Center, and Johns Hopkins University say that directed blood donation for nonmedical reasons contradicts ethical imperatives by creating separate access routes influenced by privilege or prejudice. These requests for nonvaccinated blood are driven by misconceptions about vaccine safety. But decades of advancements in donor recruitment and screening have significantly enhanced the safety of the blood supply, refuting this argument. In fact, it's directed donations, rather than anonymous community donations, that may pose accentuated health risks for prospective recipients. For example, first-time parental donors who seek to donate for their children have significantly higher rates of infectious disease marker positivity (8.6%) as compared with first-time community donors (1.09%). In addition, directed donation is resource-intensive, imposing vastly greater operational and logistic complexity than community volunteer blood donation and may contribute to shortages. The authors say that while permitting requests for unvaccinated blood may alleviate psychological distress for some patients and foster trust in medical care, it does not entitle patients or their affiliates to demand medical interventions that lack scientific justification, and physicians are not required to provide nonbeneficial interventions.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To contact corresponding author Jeremy W. Jacobs, MD, MHS John Howser at john.howser@vumc.org.

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3. The American College of Physicians announces quality agenda for internal medicine 

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-25-01040 

URL goes live when the embargo lifts     

A central component of the American College of Physicians’ (ACP) mission is to enhance the quality and effectiveness of health care by fostering excellence and professionalism in the practice of medicine. To focus ACP’s efforts, an initiative is near completion to identify clinical topics of core importance to internal medicine practice. ACP believes that such national efforts to improve health care quality must address issues that represent most clinical encounters. ACP’s quality agenda for internal medicine is published in Annals of Internal Medicine. Key components include: 

• Clinical guidelines - ACP’s commitment to rigor and transparency in the development of trustworthy clinical guidelines is globally recognized. ACP is the only medical society to earn designations as both GRADE and AGREE centers and is a founding member of the Cochrane US Network.

• Educational resources - ACP offers numerous educational resources to support physicians in their continual efforts to improve the quality of care they deliver.
• Annals of Internal Medicine – ACP's flagship peer-reviewed journal publishes research and articles essential to internal medicine practice.  

• Quality improvement (QI) support – Among other support initiatives, the ACP Physician Peer Coaching Program offers individual and group coaching to help clinicians in efforts to improve the quality of care they are delivering. 

• Advocacy - ACP advocates for policies that promote universal access to high quality care, an equitable health care system that prioritizes patients, and reducing administrative tasks for physicians, among others. ACP also offers resources to help members navigate the complex regulatory system in the United States. 
• Performance measurement - ACP is working towards identifying a core set of meaningful performance measures designed to reduce burden and guide internal medicine physicians in their efforts to select measures that are likely to improve patient outcomes.

Additional information about the resources highlighted here can be found at www.acponline.org/QI

Media contacts: For an embargoed PDF, or to speak with someone from ACP, please contact Angela Collom at acollom@acponline.org.  

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Also published in this issue:

Lyme Disease

Robert P. Smith, MD, MPH

In the Clinic

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-25-01111