Previse’s Epigenetic Test: A Game-Changer in Detecting Cancer Risk in Barrett’s Esophagus Patients
Previse, a leading gastrointestinal health company, has recently unveiled groundbreaking data on their flagship esopredict test, which demonstrates an unprecedented ability to predict the progression of Barrett’s esophagus to high-grade dysplasia or esophageal adenocarcinoma. This revelation comes from a clinical validation study published in the American Journal of Gastroenterology (AJG), highlighting the significant strides being made in gastroenterology diagnostics. The esopredict test stands out by identifying high-risk patients with a 22% average risk of progression within five years, a rate that is four times higher than the average risk. In stark contrast, low-risk patients exhibited a mere 1.9% risk, coupled with an impressive 99% negative predictive value. These statistics underscore the test’s potential to revolutionize patient management and outcomes in gastroenterology clinics worldwide.
The esopredict test operates by meticulously analyzing a patient’s DNA methylation levels, an early indicator of disease progression that often precedes visible changes. Each test result is accompanied by a personalized risk score and the patient’s probability of progression, providing clinicians with actionable insights to tailor their intervention strategies. The biomarker technology leveraged in the esopredict test was licensed from the prestigious Johns Hopkins University, adding a layer of credibility and scientific rigor to the test’s foundation. Barrett’s esophagus, characterized by the abnormal growth of cells in the esophagus due to chronic acid reflux, is the only known precursor to esophageal cancer and a significant risk factor for developing this malignancy. Therefore, early and accurate detection of high-risk patients is paramount in preventing the progression to esophageal cancer.
Sarah Laun, Vice President of Research and Development at Previse, emphasized the critical need for reliable tools in identifying high-risk patients with Barrett’s esophagus. Despite the availability of effective treatments, the absence of a dependable method to pinpoint patients at risk of cancer progression has been a significant gap in gastroenterology care. The esopredict test addresses this gap by enabling doctors to identify high-risk patients earlier, allowing for timely intervention and treatment, which could potentially save countless lives. Previse, initially known as Capsulomics, was founded in 2018 and has since made remarkable progress in advancing their esopredict test. In March 2023, the company secured a $3 million seed round to further develop this innovative diagnostic tool.
In October 2023, the National Institute of Health (NIH) awarded Previse a $1.8 million grant to support additional clinical testing of the esopredict test. This funding will facilitate more extensive research and validation, ensuring the test’s robustness and reliability across diverse patient populations. At Digestive Disease Week 2023, Previse announced another exciting development: research into using a minimally invasive swallowable sponge device to collect esophageal cytology samples. These samples are then tested for biomarkers indicative of esophageal adenocarcinoma, offering a promising alternative to traditional endoscopy. This method has been validated as a highly effective approach for detecting esophageal adenocarcinoma without the need for invasive procedures, further enhancing patient comfort and compliance.
The esopredict test’s ability to predict the likelihood of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with Barrett’s esophagus is a significant advancement in the field of gastroenterology. Published data from the American Journal of Gastroenterology (AJG) corroborates the test’s efficacy, showing that high-risk patients identified by esopredict had a 22% average risk of progression within five years. In comparison, low-risk patients had only a 1.9% risk, with a negative predictive value of 99%. These findings highlight the test’s potential to transform patient management by enabling personalized surveillance and targeted interventions based on individual risk profiles.
Johns Hopkins Kimmel Cancer Center researchers played a pivotal role in developing the esopredict test, which measures DNA methylation changes in four specific genes. This precise measurement allows clinicians to determine how frequently patients should be monitored or managed during clinical care. In a study involving biopsy samples from 240 patients with Barrett’s esophagus, the test demonstrated a 5.1% overall risk for neoplastic progression. Patients in the highest risk group had a 21.7% chance of developing high-grade dysplasia or esophageal cancer, compared to a 1.27% risk for those in the lowest risk group. These compelling results were published in the American Journal of Gastroenterology, further validating the test’s clinical utility.
The commercial availability of the esopredict test marks a new era in gastroenterology, where clinicians can now personalize surveillance and endoscopic management based on a patient’s individual risk. Traditionally, patients with Barrett’s esophagus undergo endoscopy every three to five years, a frequency that may not be sufficient to detect neoplastic changes early. Alarmingly, up to 25% of patients who develop high-grade dysplasia or esophageal cancer progress before their next scheduled endoscopy, resulting in missed opportunities for early intervention. By identifying patients with higher esopredict scores, clinicians can increase the frequency of monitoring and intervention, thereby reducing the risk of progression to esophageal cancer.
Treatments for Barrett’s esophagus typically involve removing abnormal cells before they become cancerous. However, the challenge lies in accurately identifying which patients are at the highest risk of progression. The esopredict test provides a solution by offering a precise risk assessment, enabling doctors to prioritize high-risk patients for more frequent surveillance and timely treatment. Conversely, patients with low esopredict scores can benefit from longer intervals between appointments, leading to decreased healthcare costs, reduced patient anxiety, and fewer endoscopic complications. This tailored approach to patient management represents a significant advancement in the standard of care for Barrett’s esophagus.
The esopredict test’s development involved rigorous validation, with biopsy samples from 209 patients with Barrett’s esophagus collected from six medical centers. The initial 99 samples were used to develop the test’s algorithm, while the subsequent 110 samples were utilized for testing. Additionally, a separate group of 31 patients who later developed high-grade dysplasia or esophageal cancer was included in the study. Among the 209 patients, 78 progressed to high-grade dysplasia or esophageal cancer within five years. Patients in the higher risk groups were found to be 6.4 times more likely to progress to these conditions within five years, with this risk increasing to 15.2 times for those in the highest risk group compared to the lowest risk group.
Future studies aim to include patients of diverse races and ethnicities to ensure the test’s applicability across different demographic groups. Ongoing research is also examining whether the risk score changes with biopsy location or over time, providing further insights into the test’s long-term reliability and accuracy. The esopredict test’s ability to offer a personalized risk assessment based on DNA methylation levels represents a paradigm shift in the early detection and management of Barrett’s esophagus and its progression to esophageal cancer.
The implications of the esopredict test extend beyond individual patient care, offering significant benefits to the broader medical community. By enabling earlier detection and intervention, the test has the potential to improve patient outcomes, reduce healthcare costs, and enhance the overall efficiency of gastroenterology practices. Previse’s commitment to advancing gastrointestinal health through innovative diagnostic tools is evident in their ongoing research and development efforts, supported by substantial funding from both private investors and governmental agencies like the NIH.
In conclusion, the esopredict test developed by Previse represents a monumental advancement in the field of gastroenterology. By accurately predicting the risk of progression from Barrett’s esophagus to high-grade dysplasia or esophageal adenocarcinoma, the test empowers clinicians to make informed decisions about patient management and intervention. The personalized risk scores provided by the test enable targeted surveillance and treatment, ultimately improving patient outcomes and potentially saving lives. As further research and validation efforts continue, the esopredict test is poised to become an indispensable tool in the early detection and prevention of esophageal cancer, heralding a new era of precision medicine in gastroenterology.