AKR18 Apr 2011 08:05
Akers Biosciences, Inc (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce that clinical trials have commenced for the Company's Breath Asthma Check rapid assay (the "Trials") in Clearwater, FL, USA. The trials have been designed to provide the clinical information to be included in a submission for regulatory approvals for the test in the USA and EU, which ABI intends to submit towards the end of Q3 2011.
The Breath Asthma Check rapid assay is a rapid manual assay designed to diagnose asthma at the point of care. It is a non-invasive, disposable detector, designed for one-time use, and is based on the Company's proprietary MicroParticle Catalyzed Biosensor Technology. The test is the seventh product in an expanding portfolio of breath condensate tests.
The Breath Asthma Check provides an indication of the acidity/alkalinity of exhaled breath condensate, which has been shown to be a reproducible assay of airway acidity. Airway acidification is associated with airway inflammation, which plays an important role in the pathogenesis of asthma. The Breath Asthma Check has been designed to be a reliable determination of this biomarker in exhaled breath condensate in patients suspected of asthma and could provide an inexpensive, rapid screening aid in the diagnosis of asthma at the earliest stages, to facilitate intervention and treatment. In addition, it may also serve as a compliance tool for physicians to ensure successful drug therapy regimens.
Existing methods to diagnose asthma include pulmonary function tests, such as spirometry and bronchial challenge testing, and a point of care instrument. These methods are expensive, time-consuming, and require sophisticated medical personnel. In addition, the pulmonary function tests often do not identify the underlying inflammation of the disease. By contrast, the Breath Asthma Check detector contains indicator chemistry which will undergo a simple colour change in the presence of biomarkers for asthma in the exhaled breath condensate collected from a test subject.
The Trials are expected to comprise at least 200 subjects with mild, moderate and severe asthma as well as controlled and uncontrolled subjects. The Trials are being conducted in partnership with Innovative Research of West Florida. Innovative Research is an experienced clinical research organization involved in clinical trials for pharmaceutical and medical device companies.