Results demonstrate Esopredict's ability to
predict the likelihood of progression to high-grade dysplasia or
esophageal adenocarcinoma in patients with Barrett's esophagus.
BALTIMORE, Aug. 15,
2024 /PRNewswire/ -- Previse, a gastrointestinal
health company, announced today that its clinical validation study
results for its flagship assay, Esopredict, were published in the
American Journal of Gastroenterology (AJG). The publication,
"Validation of an Epigenetic Prognostic Assay to Accurately Risk
Stratify Patients with Barrett's Esophagus," highlights 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.
"Effective treatments are available for patients with Barrett's
esophagus," said Sarah Laun, PhD, VP
of Research & Development. "However, gastroenterologists have
lacked access to an epigenetic tool that identifies patients likely
to progress towards cancer. Esopredict enables clinicians to
identify high-risk patients earlier, allowing them to intervene and
treat sooner, potentially saving patients' lives."
Esopredict is the first and only epigenetic assay to predict the
likelihood of a person diagnosed with BE of progressing to HGD or
EAC within five years. Esopredict analyzes DNA methylation levels,
an early indicator of disease progression or cancer that often
precedes morphologic changes. Each result includes a personalized
risk score and a patient's probability of progression.
The retrospective study included 240 patients whose esophageal
biopsy samples were collected across six U.S. clinical sites,
including Allegheny Health Network, Capital Digestive Health
Specialists, Johns Hopkins University,
Mayo Clinic, University of Connecticut,
and University of Maryland. Patient
samples were processed at Previse's CLIA laboratory in
Baltimore, MD. Each sample was
analyzed to quantify DNA methylation levels using biomarkers that
were integrated into a predictive algorithm to determine each
patient's likelihood of progressing to HGD or EAC within five
years. The algorithm was locked and tested on an independent
validation set.
Study results were remarkable in demonstrating that patients
identified by Esopredict as high risk had an average risk of
progression of 22% within five years, four times more likely than
the average risk based on prevalence to progress to HGD or EAC,
while low-risk patients reflected only a 1.9% risk, with a modeled
negative predictive value of 99%.
"This study represents a major leap forward for the care of
patients diagnosed with Barrett's esophagus," said senior author
and Previse Co-Founder and Advisor, Dr. Stephen J. Meltzer. "This study represents that
for the first time, we can offer gastroenterologists a precise,
quantitative, and tailored approach to personalize surveillance and
treatment management decisions."
Esopredict is exceptional among molecular diagnostics
innovations — it is uniquely designed to focus on epigenetic
biomarkers — chemical changes to a patient's DNA that control gene
expression. Such DNA methylation alterations often occur early,
before neoplastic changes emerge. By quantitatively measuring these
changes and stratifying patient risk, Esopredict conveniently
complements traditional BE management by allowing
gastroenterologists to use esophageal biopsy tissue that is
routinely collected during a patient's surveillance endoscopy,
including archived tissue.
We are excited about Esopredict's timing and ability to change
the paradigm in BE surveillance and treatment, as esophageal cancer
rates have continued to climb and claim more lives each year," said
Daniel Lunz, Chief Executive Officer
and Co-Founder of Previse.
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 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