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Study results support a test‐and‐treat strategy that could benefit symptomatic patients
Modi’in, Israel – April 13, 2015 – Exalenz Bioscience (TASE: EXEN), a leader in developing and marketing
non‐invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver
diseases, today announced new published data supporting the use of the Company’s point‐of‐care
BreathID urea breath test for diagnosing Helicobacter pylori infection (H. pylori) in the emergency
department (ED) setting. The study was published online in Annals of Emergency Medicine on March 24.
“We are encouraged by these study results, confirming the clinical utility of the BreathID test for H.
pylori as part of a successful test‐and‐treat strategy in the emergency room,” said Larry Cohen, CEO of
Exalenz Bioscience. “Approximately two thirds of the world’s population is infected with H. pylori, which
is frequently undiagnosed and untreated, and we believe that our novel, non‐invasive test will not only
help diagnose patients rapidly and inexpensively at the point of care, but could also accelerate delivery
of treatment to patients who need immediate medical intervention.”
The prospective cohort study, developed to examine the feasibility of a test‐and‐treat strategy for H.
pylori infection, enrolled 212 patients from an urban academic medical center ED with a previously
established high prevalence of H. pylori. Symptomatic patients received the BreathID test, and those
who tested positive were prescribed standard of care triple therapy medication (omeprazole,
clarithromycin and amoxicillin). All participants were given a baseline questionnaire detailing general
demographic information and nature of pain severity, and those testing positive for H. pylori were also
asked additional questions about their medication adherence. Enrolled participants were contacted by
telephone two weeks following the initial assessment with the same questions.
Forty‐nine patients (23%) (95% confidence interval [CI] 18% to 30%) had a positive result, 33 of 49 (67%)
(95% CI 53% to 79%) self‐reported receiving the triple therapy medication as prescribed at follow‐up, 23
of 49 (47%) (95% CI 34% to 61%) were retested, and the eradication rate of H. pylori was 87%
(n=20/23)(95% CI 68% to 95%) in patients who returned for a retest and reported medication
compliance. Additionally, there was a significant reduction in pain severity, regardless of H. pylori
A recent publication in Expert Review of Molecular Diagnostics noted that standard serological tests for
detecting H. pylori may be suboptimal due to lack of overall accuracy, and are consequently not
recommended by the U.S., European and Asia‐Pacific Consensus Guidelines. In addition, antibody titers
may decrease up to 6 months after successful treatment, limiting the use of the test for post‐eradication
“While a test‐and‐treat approach to H. pylori infection is currently not the standard of care in the
emergency room, these data demonstrate that this strategy is viable and may confer additional benefits
including early identification and treatment of peptic ulcer disease, and potential to eradicate cases of
infection that could lead to an increased risk of developing gastric cancer,” said Andrew Meltzer, M.D.,
George Washington University Department of Emergency Medicine and principal investigator of the
study. “Furthermore, the BreathID test is a noninvasive, accurate and rapid test for confirming H. pylori
infection and is particularly well suited for use at the point‐of‐care in the emergency department
because it offers the significant clinical advantage of only detecting active infection, unlike standard
antibody‐based testing platforms.”
About Exalenz Bioscience:
Exalenz Bioscience develops and markets diagnostic and monitoring systems that use the breath to
diagnose and help manage GI and liver conditions. The company’s flagship BreathID Hp test detects the
presence of the H. pylori bacteria, associated with various illnesses including gastric cancer. Exalenz
holds regulatory approvals in Europe the US and Israel for H. pylori detection and is currently in the
process of obtaining approvals for additional gastrointestinal and liver applications.
About Helicobacter Pylori
Helicobacter pylori (H. pylori), is a Gram‐negative, microaerophilic bacterium found in the stomach and
linked to the development of various digestive conditions as well as peptic ulcers and gastric cancer.
According to reports, approximately 20% of people under 40 years old and half of adults over 60 years
old in the U.S. are infected, with higher rates in developing countries. Usually, H. pylori is diagnosed
using a blood test. Use of blood testing is limited, however, as it is more invasive and doesn’t directly
detect the presence of the bacteria. For these and other reasons, leading practice associations like the
ACG recommend breath testing as a non‐invasive choice for the diagnosis, management and eradication
of H. pylori.
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1Expert Rev. Mol. Diagn. Early online, 1–14 (2015)