LOS ANGELES–(BUSINESS WIRE)–Aug 7, 2012–Fidelis Diagnostics, Inc., a rapidly growing healthcare company providing innovative diagnostic services nationally, today announced it has entered into a strategic partnership with Exalenz Bioscience, Inc., a medical device company specializing in the diagnosis and monitoring of gastroenterological and liver related diseases. Fidelis Diagnostics will now offer Exalenz’ advanced Helicobacter pylori (H. pylori) Breath Testing System, the BreathID® System, to its expanding base of 2,000 physicians.
“In addition to providing ElectroDiagnostics, Home Sleep Studies, Audiology Testing and ABI technology, we are pleased to expand the services we provide to physicians by adding Exalenz’ breakthrough breath testing solution for the detection of H. pylori infection,” said Amir London, COO of Fidelis Diagnostics, Inc. “Our strategic relationship with Exalenz further demonstrates our continued commitment to bringing only the highest quality diagnostics to our physicians, so they can better serve their patients.” The BreathID® System is a non-radioactive breath test platform capable of analyzing parts-per-million changes in carbon 13 and carbon 12 ratios in a patient’s breath. This system has FDA 501(k) clearance for the detection of H. pylori bacteria and is distinguished by its ability to continuously measure exhaled breath, rapid, real-time results, single-button operation for ease-of-use, and documented superior sensitivity and specificity.
“Exalenz has seen continued adoption of our BreathID platform amongst primary care physicians, who encounter H. pylori infected patients every day and understand the consequences of untreated infection,” said Mark Hood, Vice President of North American Sales for Exalenz Bioscience. “Fidelis has solid experience delivering in-office diagnostic solutions that advance patient care and enhance the well-being of the primary care practice. We greatly look forward to working with Fidelis to introduce the BreathID breath test to their expanding base of physician customers.” Helicobacter pylori is a bacterium that infects around 1 in 4 Americans. Found in the stomach and small intestine of infected persons, it has been demonstrated to contribute to a variety of conditions, ranging from relatively common symptoms such as dyspepsia and abdominal pain to more severe conditions, including gastritis, ulcers and, in some cases, cancer. Many patients with H. pylori symptoms take long-term prescriptions of acid suppressing medications, like proton pump inhibitors (PPIs) which do not treat the underlying cause. Conclusively eradicating H. pylori through treatment depends on an accurate diagnosis of active H. pylori infection. Urea Breath Testing (UBT) and the BreathID System have been proven to accurately and reliably detect active infection and confirm eradication post-treatment, and the test is supported by the American College of Gastroenterology’s clinical guidelines.
With the BreathID® System, Fidelis offers physicians an in-office testing solution using a dedicated BreathID device that is located in the physician’s office. With this option, H. pylori testing can be done on the spot with results received in about 10 minutes.
About Exalenz Exalenz Bioscience develops and markets medical equipment for breath testing for the purposes of diagnosis and management of digestive system and liver conditions globally. The company sells the BreathID® System together with proprietary disposable test kits. The BreathID® System has been proven effective for clinical use in identifying the presence of the H. pylori bacteria and is presently undergoing clinical testing for use in the field of liver function, liver cirrhosis, and digestive disturbances. Exalenz holds regulatory approvals in Europe and the U.S. for some of the applications and the company is currently in process of applying for approvals for additional indications. For additional information, please visit the company’s website: http://www.exalenz.com/ and the website dedicated to the H. pylori field: http://www.breathid.com/.
About Fidelis Diagnostics Headquartered in Los Angeles, Fidelis Diagnostics is a rapidly growing healthcare company providing a portfolio of innovative diagnostic services to physicians nationwide. Since its inception in 2004, the company has built an exceptional reputation for its quality diagnostics, high standard of business ethics and outstanding service, improving patient health with convenient testing, while reducing overall healthcare costs. In addition to H. pylori testing, Fidelis services include ElectroDiagnostics, Home Sleep Studies, Audiology Testing and ABI technology being provided to thousands of physicians across the United States. For more information, visit www.fidelisdiagnostics.com.
