18 Apr 2011 07:00
Embargoed: 0700hrs, 18 April 2011
Akers Biosciences, Inc.
("ABI" or the "Company")
ABI Starts Clinical Trials for Breath Asthma Check Rapid Assay
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.
Dr Raymond F. Akers, Jr., Executive Chairman, commented:
"We believe that the Breath Asthma Check embodies everything that a good point of care test should be. It can be performed just about anywhere, it does not involve complex instrumentation or require technically sophisticated personnel, and its cost to the end user will be relatively inexpensive. However, the real power of this product is what it can do for millions of people that perhaps have a persistent cough, or trouble with waking up during sleep, or persistent allergic rhinitis, but ignore these symptoms. These people may have underlying asthma, and this easy to perform test could positively impact their lives."
Enquiries:
Thomas A. Nicolette, President and CEO
Dr Raymond F. Akers, Jr., Executive Chairman
Tel. +1 856 848 8698
Antony Legge or Noelle Greenaway
Daniel Stewart & Company plc (Nomad and Broker)
Tel. +44 (0)20 7776 6550
Ben Simons
M: Communications
Tel. +44 (0)20 7920 2340
About Akers Biosciences, Inc.
Akers Biosciences develops, manufactures, and supplies rapid, point of care screening and testing products designed to bring healthcare information both rapidly and directly to the consumer or healthcare provider. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company's state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. ABI has aligned with major healthcare companies and high volume medical product distributors to maximise product offerings, and to be a major worldwide competitor in diagnostics. Additional information on the Company and its products can be found at www.akersbiosciences.com