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