TEST:

Cologuard®

P=N/A, N=300, Active, not recruiting, University of Chicago | Enrolling by invitation --> Active, not recruiting

"Exact Sciences Corp...announced the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus test during the American College of Gastroenterology (ACG) Annual Meeting. ACG takes place October 25-30, 2024, in Philadelphia, Pennsylvania. Exact Sciences will also present new data on improving adherence to help close the gap in CRC screening. ACG abstracts are available on the meeting website....Researchers used a validated simulation model to assess the benefit to burden ratio of the Cologuard Plus test and other established and emerging CRC screening options. Benefit was defined as life-years gained and burden as the lifetime number of colonoscopies."

Patients with a previously negative colonoscopy and subsequent positive MT-sDNA test were found to have a high rate of advanced adenomas on follow-up colonoscopy (30%). Thus, in patients with a previously negative colonoscopy, MT-sDNA testing may be a reasonable alternative screening option.

P=N/A, N=1851, Active, not recruiting, Exact Sciences Corporation | N=5280 --> 1851 | Trial completion date: Mar 2029 --> Jul 2025 | Trial primary completion date: Mar 2029 --> Jul 2025

Colonoscopy is the most commonly used form of CRC screening pre-HT with other modalities used more frequently in cases requiring mechanical or inotropic support. Further studies should explore optimal post-HT screening guidelines in an immunosuppressed patient population.

Over a 6-month study period, 51 colonoscopists performed 15,719 colonoscopies of which 194 were performed for positive MT-sDNA testing and 82 for positive FIT testing. Among the patients positive MT-sDNA testing, NDR was non-significantly increased in CADe rooms compared to non-CADe rooms (82% versus 75.7%, p=0.4; Table). Adenoma detection non-significantly increased in CADe rooms as well (76% versus 65.3%, p=0.2).

The following themes emerged: 1. Lack of funding, government programs, and insurance to cover the costs associated with colonoscopies. 2.

A total of 106 participants completed the survey.. Of the participants, majority were female (62.2%, n=66), White (23.3% n=91), had a college degree or higher (14.4%, n=56), insured (16.4%, n=64), and had heard about colorectal cancer (79.4%, n=85). Majority were not able to identify genetics (82.6%), smoking (89.7%), alcohol consumption (90.8%), and diet rich in red meat (89.0%) as known risk factors for developing CRC.

The average wait time for a screening colonoscopy was 4 months. From February 2024-May 2024, 226 patients were texted. 136 (60%) patients responded, and of those 38 (28%) were interested and eligible for Cologuard.

Of 5,827 ordered Cologuard ® tests, 248 patients had prior colonoscopies. The average time from initial colonoscopy to Cologuard ® testing was 7.3 years. Of the 63 patients who had a positive Cologuard ® test, 41 patients (65%) completed follow-up colonoscopy.

In our patient, prompt evaluation of the small bowel after an initial negative endoscopy led to a diagnosis of SBA at an earlier stage, amenable to surgical therapy with curative intent. Figure: Jejunal mass on balloon enteroscopy.

Our patient did have a positive FIT and Cologuard tests prior to colonoscopy. Effort should be made to intubate the terminal ileum, and EGD should be considered given increased rates of small bowel cancer in CF patients.

Of the 45 patients who were counseled with the Epic SP, 31.1% of patients completed the recommended screening, but 68.8% did not complete the screening. Of the patient encounters where the Epic Smart phrase was not utilized, only 2.1% of patients completed the recommended screening test (p< 0.001). Of the patients who were counseled using the Epic Smart phrase, colonoscopy was the most common modality ordered, but Cologuard test had the highest rate of follow-up (70%).

Although only a handful cases of gastric PG have been reported in the literature, we believe the incidence is higher as they are frequently mistaken for hyperplastic polyps. Figure: Figure 1 & 2

We identified 70 patients who met study criteria, of whom 20 patients (28.6%) developed new disease in the form of either de novo cancer or recurrence of prior cancer. Of the 20 patients with new disease, 14 patients (70%) had primary or metastatic involvement of the aerodigestive tract, including 8 patients with de novo cancer and 6 patients with recurrence of prior cancer. Of the 8 patients who developed de novo cancer involving the aerodigestive tract, 3 patients were diagnosed with aerodigestive tract cancer on combined upper endoscopy at the time of diagnostic colonoscopy.

The study included 574 participants, with 312 positive Cologuard™ results and 262 positive FIT results. In the Cologuard™ group, 93.3% were white and 52.9% were female, with a mean age of 71.4 ± 7.4 years. In the FIT group, 84.4% were white and 44.3% were female, with a mean age of 76.6 ± 8.1 years.

Our sample included a total of 341 patients with positive MT-sDNA testing. Within our sample, Caucasians were the most represented ethnicity 270/341 (79.2%) and the Median age of screening was 64.4 years of age. Additionally, the majority had no prior colonoscopy 267 (78.3%).

Of 1387 PCPs contacted, 214 responded to the survey. A majority (78%) indicated colonoscopy as their preferred screening CRC test. 13.6% favored Cologuard as the initial screening method while a smaller percentage opted for FOBT or FIT test.

"Exact Sciences Corp...today describing the projected impact of the Cologuard test on patients, health care professionals, and the U.S. health care system since its FDA approval 10 years ago."

Proposed solutions across the three regions will inform a multilevel intervention in a pragmatic trial to increase CRC screening uptake in CHCs.

P=N/A; Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Oct 2024 --> Jun 2024

Why does colorectal cancer (CRC) remain the most preventable yet least prevented cancer in the US? A look at CRC screening gaps, the importance of support and multi-modality protocols that help address screening barriers in African Americans.

Early CRC is a serious problem affecting PwCF. Stool-based testing for CRC has unknown performance characteristics in the high-risk CF population. In this preliminary data, we have seen high interest across the United States in alternatives to colonoscopy for CRC screening.

We show for the first time that a panel of 2 rectal miRs had an excellent performance for diagnosis. It is striking that this simple panel outperformed classic tests such as FIT or Cologuard (∼25% and ∼45% respectively). This proof of concept study suggests a simple rectal swab may be able to personalize CRC screening.

"Geneoscopy announced Monday that it has filed a lawsuit against Exact Sciences in federal court in Delaware in relation to a patent that is central to both companies' colorectal cancer screening tests."

Following the first publication, significant increases in Google search interest were observed. The mean search volume for "Delaying Colonoscopy" increased by 0.9038 (p = 0.038), "Cologuard" by 0.5247 (p = 0.040), and "Colonoscopy Anesthesia" by 0.8654 (p = 0.039).Our analysis revealed a significant increase in Google searches for colonoscopy anesthesia following the policy change. The data depicts increases in Google searches when news articles published the news about Blue Cross Blue Shield’s policy update.

P=N/A; Not yet recruiting --> Recruiting | Initiation date: Jan 2024 --> May 2024 | Trial primary completion date: May 2024 --> Oct 2024

P=N/A; Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Oct 2024

P=N/A; Recruiting --> Active, not recruiting

"Exact Sciences Corp...will present 10 abstracts highlighting the breadth and depth of the company’s screening and diagnostic portfolio at the American Society of Clinical Oncology® (ASCO®) Annual Meeting, taking place May 31 – June 4, 2024, in Chicago, Ill. Presentations will include new data confirming both the predictive and prognostic value of the Oncotype DX Breast Recurrence Score® test in racially and ethnically diverse patients. Exact Sciences will also present data on its approach to multi-cancer early detection (MCED) across multiple tumor types, plus additional real-world evidence showing optimized screening adherence strategies for the Cologuard® test as well as high adherence rates for repeat screenings."

"Exact Sciences Corp...announced that a District Court judge denied in part Geneoscopy’s (defendant) motion to dismiss a patent infringement lawsuit filed by Exact Sciences (plaintiff) in the United States District Court for the District of Delaware. This ruling paves the way for Exact Sciences to seek relief for Geneoscopy’s future infringement and false advertising."

No abstracts available

No abstract available

CMSmin could contribute to CRC control by achieving screening in those who will not use established methods. Substituting blood-based testing for established effective CRC screening methods will require higher CRC and APL sensitivities that deliver programmatic benefits matching those of FIT. High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers. APL detection should not be penalized by a definition of test specificity that focuses on CRC only.

While challenges remain, including optimizing diagnostic accuracy and cost considerations, ongoing research and clinical trials hold promise for integrating stool DNA testing into routine CRC screening programs. With continued advancements and validation efforts, stool DNA testing has the potential to revolutionize CRC screening, ultimately reducing cancer-related morbidity and mortality on a global scale.

He holds 37 US patents and is an elected fellow of the American Institute of Medical and Biological Engineering. He is also a co-founder of Droplet Biosciences.

He holds 37 US patents and is an elected fellow of the American Institute of Medical and Biological Engineering. He is also a co-founder of Droplet Biosciences.

The study encompassed 82 patients, with 40 patients (48.78%) being up-to-date with colorectal cancer screening. This screening included Colonoscopy (65% for 26 patients), FIT/Cologuard (30% for 12 patients), with no patients opting for FlexSig, and 2 patients choosing FOBT (5%). For comparison, a random cohort of patients not identifying as LGBTQ+ was chosen.

Out of 506 patients 356 had an active electronic portal and received the message. Of those patients 140 (39%) read the message and only six patients (4% of readers) had an order placed screening (three for colonoscopy one FIT and two for Cologuard). Analysis of the 8-week period prior to electronic messages revealed 43 referrals placed for colonoscopy and five stool-based tests ordered.

1% of patients opting to get scheduled or were already scheduled from those who replied (Figure ). ConclusionPersonalized MyChart messages to patients are an easy efficient and cost-effective method to serve as reminders and engage patients in conversations related to the completion of CRC Surveillance.

This knowledge will help increase CRC screening rates improve wait times for high-risk colonoscopies by reducing the overall patient load and decrease inappropriate usage of Cologuard. We hope to apply these findings to our resident ambulatory clinic by improving rates of CRC screening and Cologuard prescription in an urban underserved patient population.

In a large retrospective cohort study the PPV of Cologuard for detecting advanced adenomas appears to be comparable between pts not on anticoagulants or antiplatelets and those on either antiplatelet or anticoagulant agents or both agents.