Peer-Reviewed Study Validates Reliability and Reproducibility of Esopredict, Previse’s Prognostic Assay for Patients with Barrett’s Esophagus
BALTIMORE, Sept. 11, 2024 /PRNewswire/ — Previse, a gastrointestinal health company, announced the publication of a study in Diagnostics highlighting the analytical validation of Esopredict, a first-in-class DNA methylation test for identifying patients with precancerous Barrett’s esophagus (BE) who are likely to progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in the future. .
“This analytical validation study compliments Esopredict’s recently published clinical validation study,” said Sarah Laun, PhD, VP of Research and Development. “The results demonstrate the robust analytical performance of the Esopredict assay performed in our Baltimore-based CLIA laboratory.”
This publication, Analytical Validation of Esopredict, an Epigenetic Prognostic Assay for Patients with Barrett’s Esophagus, rigorously confirms Esopredict’s robustness and reproducibility. The data further validates inter and intra-assay precision, demonstrating high reproducibility over a range of risk levels, <9% and <5%, respectively, with recommendations according to CLIA/CLSI guidelines (CV<20%). Study results also demonstrate that Esopredict performs to the utmost validation standards with high repeatability and reproducibility, as well as high analytical sensitivity and specificity.
Esophageal cancer is amongst the deadliest cancers globally and is tied as the second most lethal in the U.S., behind pancreatic cancer. While it is well-known that individuals diagnosed with BE are at a higher likelihood to develop HGD or EAC, a validated, highly accurate, DNA-based prognostic solution has not been available until now. Esopredict offers gastroenterologists and their patients living with BE the ability to effectively stratify the patients’ risk of developing HGD or EAC cancer within five years to guide surveillance and treatment decisions.
About Previse and Esopredict:
Established in 2018, Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. Previse’s mission is to save lives and improve patient health through prevention and early detection. Previse leverages groundbreaking biomarker technology developed by Stephen Meltzer, M.D., and his GI Early Detection Biomarker Lab at the Johns Hopkins University School of Medicine. This technology, backed by funding from the National Institutes of Health (NIH) and decades of research, forms the foundation of Previse’s commitment to combating GI diseases, including cancer. At the forefront is Esopredict, a highly sensitive DNA methylation-based test designed to predict the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with precancerous Barrett’s esophagus. With a turnaround time of about 2 weeks after a sample is received, Esopredict empowers gastroenterologists to tailor effective treatment strategies, marking a pivotal advancement in the battle against esophageal cancer.
For additional information about Esopredict and full study details, please visit www.previsedx.com.
Media Contact:
Rebekah Epstein
rebekah@fifteen-media.com
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SOURCE Previse
