Latest news with #EsoCheck
Medscape
12 hours ago
- Health
- Medscape
Less Invasive Screening May Identify Barrett's Earlier
A new combination modality demonstrated excellent sensitivity and negative predictive value compared with endoscopy in a prospective study of at-risk veterans screened for Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), a small comparative study in US veterans found. BE is up to three times more prevalent in veterans than in the general population. This and other minimally invasive approaches may reduce patient anxiety and increase screening rates, according to investigators led by Katarina B. Greer, MD, MS, of the VA Northeast Ohio Healthcare System and Case Western University in Cleveland. Such screening platforms are expected to open a window on improved prognosis for EAC by offering well-tolerated, office-based testing, the authors wrote in The American Journal of Gastroenterology. Greer and colleagues compared standard upper endoscopy with EsoCheck (EC), a nonendoscopic esophageal balloon cell-sampling device coupled with EsoGuard (EG), a DNA-based precancer screening assay, with standard upper endoscopy, an FDA-approved minimally invasive alternative. Sensitivity and specificity of combined EC/EG for esophagogastroduodenoscopy (EGD)-detected BE/EAC were 92.9% (95% CI, 66.1-99.8) and 72.2% (95% CI, 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI, 18.6-49.1) and 98.6% (95% CI, 92.4-100), respectively. 'With its strong negative predictive power, this screening modality could be a first-line tool available to a greater number of patients,' Greer and associates wrote. 'Data from this test support the notion that EC could be performed as a triaging test to increase the yield of diagnostic upper endoscopy 2.5-fold.' The US rates of EAC have increased more than six-fold in the past four decades and continue to rise. In 2023, 21,560 cases of EAC were diagnosed here. The prognosis for EAC is still poor, with fewer than 22% of patients surviving beyond 5 years. Current guidelines recommend sedated EGD for patients with chronic gastroesophageal reflux disease (GERD) and additional BE risk factors such as smoking, obesity, and family history. This strategy, however, often fails to detect BE when symptoms are well controlled with over-the-counter or physician-prescribed therapies, Greer and colleagues noted. It also fails to detect BE in individuals without GERD, who comprise 40% of those who develop EAC. Fewer than 5% of EACs are diagnosed as early-stage lesions caught by surveillance of patients with previously detected BE. Study Details The researchers recruited veterans meeting American College of Gastroenterology criteria for endoscopic BE and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center. Of 782 eligible veterans, 130 (16.6%) entered the study and 124 completed screening. Common reasons for nonparticipation included completion of upper endoscopy outside of the VA healthcare system, lack of interest in joining a research study, and no recommendation for screening from referring gastroenterology or primary care providers. Eligible candidates had gastroesophageal reflux disorder plus three additional risk factors, such as smoking, higher BMI, male sex, age 50 years or older, and family history. The mean number of risk factors was 4.1. 'Available data suggest that family history is the strongest predictor of BE diagnosis, as prevalence of BE among those with family history was 23%,' Greer's group wrote. 'This points to high priority of pursuing screening in patients with family history of the condition, followed by patients who share multiple risk factors.' All participants completed unsedated EC-guided distal esophageal sampling followed by a sedated EGD on the same day. The prevalence of BE/EAC was 12.9% (n = 14/2), based on standard EGD. 'The study was not powered to prospectively determine EC diagnostic accuracy for subgroups of nondysplastic and dysplastic BE and EAC. These data are reported for this device in development studies but not available for our study population,' the authors wrote. In comparison, they noted, the Cytosponge-TFF3, another nonendoscopic screening device for EAC and BE, exhibited lower sensitivity of 79.5%-87.2%, depending on lesion length, but higher specificity of 92.4%. Procedural Anxiety Baseline scores on the short-form six-item Spielberger State-Trait Anxiety Inventory-6 (STAI-6) revealed notable levels of periprocedural anxiety. STAI-6 scores range from 20 to 80, with higher scores indicating more severe anxiety. In the VA study, scores ranged from 20 to 60, and most domains constituting the scores were the same before and after the procedure. Participants did, however, report a statistically significant decrease in sense of worry after EC and reported good tolerability for both EC and EG. Offering an outsider's perspective on the study, Joshua Sloan, DO, an esophageal gastroenterologist at University of Minnesota Medical Center in Minneapolis, said that with the acceleration of US rates of EAC, developing a nonendoscopic screening tool to improve identification of Barrett's and perhaps early EAC is important. 'The study by Greer et al helps support the use of nonendoscopic screening with EsoCheck and EsoGuard to identify these conditions,' he told Medscape Medical News. 'It will be interesting to see similar studies in the non-VA population as well. As the study notes, veterans are an enriched population with a higher prevalence of Barrett's esophagus.' Ultimately, Sloan added, 'the hope is to increase our ability to identify and manage BE before it becomes EAC. Nonendoscopic screening tools have the potential to increase diagnosis and funnel the appropriate patients for endoscopic surveillance.' The Bottom Line 'Calculations regarding effectiveness of the two-step screening strategy afforded by EC indicate that the burden of screening would be reduced by at least half (53%),' the authors wrote. Since the estimated size of the US screen-eligible population ranges from 19.7 million to 120.1 million, noninvasive tools could significantly decrease EGD procedures. A formal cost effectiveness analysis is being conducted and will be published separately. This study was funded by a Department of Defense award.
Yahoo
27-02-2025
- Health
- Yahoo
Renowned Investigators Awarded $8 Million NIH Grant to Study Lucid Diagnostics' EsoGuard® in At-Risk Patients without Symptomatic GERD
Lucid to support study of this expanded indication for esophageal precancer testing in partnership with NIH investigators NEW YORK, Feb. 27, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that a consortium of prestigious academic medical centers, led by principal investigators from Case Western Reserve University (CWRU) and University Hospitals (UH), has been awarded an $8 million National Institutes of Health (NIH) R01 grant to conduct a five-year clinical study designed to evaluate esophageal precancer detection using Lucid's EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test among at-risk individuals without symptoms of chronic gastroesophageal reflux disease (GERD). The study, "A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett's Esophagus and Its Progression," aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett's Esophagus or BE) to prevent esophageal cancer (EAC) within a non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association's (AGA) risk criteria for screening will be recruited across five participating research centers: University Hospitals, University of Colorado, Johns Hopkins University, University of North Carolina, and Cleveland Clinic. "Patients without GERD symptoms account for nearly half of prevalent esophageal cancer cases," said Amitabh Chak, M.D., Professor of Medicine and Oncology at CWRU, gastroenterologist at UH, and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center. "However, these individuals would be excluded from screening based on the American College of Gastroenterology (ACG) guidelines where chronic GERD is a mandatory prerequisite. We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened, and to do so in a manner that does not over-tax limited endoscopy resources. Given the dismal 20% five-year survival associated with esophageal cancer, increased detection and treatment of BE is the best strategy to meaningfully impact esophageal cancer-related mortality." "We are excited to support this landmark study, continuing our longstanding collaboration with Drs. Amitabh Chak, Sanford Markowitz, and Joseph Willis, principal investigators on the NIH grant, and are gratified that the NIH has committed substantial resources focused on our technology," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "This study has the potential to significantly expand the target population for EsoGuard esophageal precancer testing." The technology behind EsoGuard and EsoCheck was developed at CWRU and UH by faculty members Sanford Markowitz, M.D., Ph.D., Amitabh Chak, M.D., Joseph Willis, M.D., and Helen Moinova, Ph.D. They have collaborated closely with the Lucid team since Lucid licensed the technologies on an exclusive basis from CWRU in 2018. About Lucid DiagnosticsLucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients. For more information about Lucid, please visit and for more information about its parent company PAVmed, please visit View original content to download multimedia: SOURCE Lucid Diagnostics Sign in to access your portfolio
