Point-of-Care Breath Test Rapidly Detects Active H. pylori

A novel, nonradioactive breath test system for the qualitative detection of active Helicobacter pylori infection in symptom-presenting patients provides improved efficiency and accuracy for diagnosis and treatment monitoring.

Exalenz Bioscience (Modiin, Israel) offers its "BreathID Hp" test for noninvasive, presumptive detection of H. pylori (Hp). BreathID Hp is initially designed to support the needs of urgent care facilities, gastroenterologists, bariatric specialists, and PCPs. The ability to rapidly, conveniently, and accurately detect Hp in patients presenting with related symptoms "is an important addition to any physician's office or clinical laboratory," said Steven Eitan, CEO of Exalenz. BreathID Hp detects H. pylori in 10–15 minutes through a simple, single-step, nonradioactive 13C-urea based breath test. The BreathID System platform is capable of analyzing parts-per-million changes in carbon 13 and carbon 12 ratios in human breath. The device is of a compact, benchtop footprint and at 13.6 kg is easily transported.

There are currently three main types of Hp tests being used: blood, stool, and breath tests. Leading practice associations recommend the urea breath test (UBT). Blood and stool tests are somewhat invasive, take 1-3 days with significant lab processing costs, and blood tests are prone to false positives. Furthermore, eradicating Hp through treatment depends on accurate detection of active Hp infection at initial diagnosis and in post-treatment testing. “Given [...] the shortcomings of common blood tests for Hp, which do not accurately differentiate between active and prior infection, we believe we have a compelling offering to advance patient care,” said Mark Hood, Vice President of North American Sales for Exalenz. UBT is currently the most accurate noninvasive means for identifying active Hp infection.

In comparison to the cumbersome radioactive (14C) UBT at 96% sensitivity and specificity, with BreathID Hp a patient drinks a safe low dosage of nonradioactive 13C-labeled urea, then breaths normally into the device while it analyzes in real-time the continuous flow of fresh breath, then rapidly provides a 99% accurate written diagnosis report (real-time analysis is powered by the BreathID platform, which incorporates a number of proprietary core technologies). This enables an "informed" treatment protocol – allowing physicians to immediately prescribe treatment if deemed necessary, rather than prescribing potentially unnecessary preventative treatment "just in case" while waiting for 1–3 days and for less reliable results.

Exalenz provides two distinct offerings. One is the "Hp FasTest" performed with a dedicated BreathID System device located in a physician's regular or emergency room office, enabling point-of-care Hp testing. A non-rapid (1–3 days) but more centralized option will be the "Hp BagTest,” a send-in service at dedicated centers, initially in certain USA states. The first Breath Test Center is being established in cooperation with Metabolic Solutions, a company with 20 years’ experience in breath test-sample analysis. For establishment of channels to provide the device and kits in the USA, Mr. Dennis Boyle (previously of Siemens USA) has been appointed Vice-President and National Manager of Exalenz in the USA.

BreathID Hp is FDA-cleared in the USA and is CE-approved in Europe for diagnosing and treating H. pylori.

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Exalenz Bioscience